nicotinic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
nicotinic acid or nicotinoyl alcohol derivatives	2835	59-67-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: niacin potassium niacin magnesium nicotinic acid vitamin b3 (niacin) 3-pyridinecarboxylic acid niaspan niacin niacor Vitamin B3	A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has PELLAGRA-curative, vasodilating, and antilipemic properties. Molecular weight: 123.11 Formula: C6H5NO2 CLOGP: 0.80 LIPINSKI: 0 HAC: 3 HDO: 1 TPSA: 50.19 ALOGS: -0.17 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

niacin potassium
niacin magnesium
nicotinic acid
vitamin b3 (niacin)
3-pyridinecarboxylic acid
niaspan
niacin
niacor
Vitamin B3

A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has PELLAGRA-curative, vasodilating, and antilipemic properties.

Molecular weight: 123.11
Formula: C6H5NO2
CLOGP: 0.80
LIPINSKI: 0
HAC: 3
HDO: 1
TPSA: 50.19
ALOGS: -0.17
ROTB: 1

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.20	g	O
0.20	g	P
2	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	18 mg/mL	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	101.53 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

Date	Agency	Company	Orphan
July 24, 1957	FDA	MEDPOINTE PHARM HLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Flushing	281.57	10.44	341	56304	74746	63357631
Contraindicated product administered	160.98	10.44	8	56637	217640	63214737
Synovitis	144.46	10.44	5	56640	186913	63245464
Systemic lupus erythematosus	117.63	10.44	22	56623	208896	63223481
Treatment failure	109.86	10.44	22	56623	199021	63233356
Completed suicide	108.82	10.44	5	56640	145668	63286709
Infusion related reaction	106.32	10.44	43	56602	245478	63186899
Glossodynia	104.70	10.44	17	56628	178859	63253518
Maternal exposure during pregnancy	101.21	10.44	35	56610	220027	63212350
Off label use	98.74	10.44	293	56352	674169	62758208
Drug intolerance	98.08	10.44	79	56566	308582	63123795
Drug ineffective	97.62	10.44	542	56103	1044223	62388154
Product use in unapproved indication	92.36	10.44	23	56622	179057	63253320
Pericarditis	90.77	10.44	7	56638	131572	63300805
Product use issue	84.10	10.44	46	56599	220474	63211903
Wound	80.34	10.44	23	56622	163240	63269137
Muscle spasms	79.94	10.44	313	56332	155837	63276540
Product dose omission issue	76.93	10.44	412	56233	233901	63198476
Skin burning sensation	72.34	10.44	72	56573	12662	63419715
Toxicity to various agents	64.87	10.44	75	56570	247175	63185202
Duodenal ulcer perforation	61.98	10.44	4	56641	87205	63345172
Diarrhoea	61.42	10.44	936	55709	714430	62717947
Lower respiratory tract infection	60.87	10.44	21	56624	132286	63300091
Fall	60.38	10.44	574	56071	391760	63040617
Helicobacter infection	58.54	10.44	7	56638	92778	63339599
Therapeutic product effect decreased	56.99	10.44	53	56592	193134	63239243
Arthropathy	54.58	10.44	78	56567	234714	63197663
Drug abuse	52.52	10.44	3	56642	72515	63359862
General physical health deterioration	48.71	10.44	65	56580	201337	63231040
Therapy cessation	48.63	10.44	93	56552	30364	63402013
Therapeutic product effect incomplete	47.77	10.44	26	56619	125030	63307347
Pruritus	46.10	10.44	509	56136	360944	63071433
Device expulsion	44.36	10.44	97	56548	34825	63397552
Unevaluable event	44.29	10.44	123	56522	51263	63381114
Dizziness	41.68	10.44	575	56070	429350	63003027
C-reactive protein increased	40.28	10.44	17	56628	94690	63337687
Psoriasis	40.23	10.44	169	56476	86788	63345589
Intentional product use issue	40.22	10.44	33	56612	127859	63304518
Myalgia	39.11	10.44	244	56401	146285	63286092
Rheumatoid arthritis	38.62	10.44	108	56537	253711	63178666
Full blood count decreased	38.56	10.44	77	56568	25947	63406430
Folliculitis	38.29	10.44	8	56637	70309	63362068
Paraesthesia	37.98	10.44	255	56390	156711	63275666
Joint swelling	37.90	10.44	157	56488	327509	63104868
Feeling abnormal	36.46	10.44	242	56403	148150	63284227
Discomfort	34.69	10.44	60	56585	167314	63265063
Alopecia	34.67	10.44	169	56476	337367	63095010
Neuropathy peripheral	33.98	10.44	195	56450	113472	63318905
Device dislocation	32.19	10.44	71	56574	25634	63406743
Hot flush	31.56	10.44	109	56536	51050	63381327
Exposure during pregnancy	31.12	10.44	57	56588	155490	63276887
Condition aggravated	30.89	10.44	221	56424	401996	63030381
COVID-19	29.96	10.44	34	56611	113069	63319308
Deep vein thrombosis	29.96	10.44	151	56494	83649	63348728
Fatigue	29.42	10.44	1016	55629	887012	62545365
Liver injury	28.89	10.44	9	56636	60511	63371866
Hepatic enzyme increased	27.95	10.44	90	56555	202238	63230139
Irritable bowel syndrome	27.52	10.44	20	56625	82392	63349985
Back pain	27.48	10.44	358	56287	263787	63168590
Burning sensation	26.94	10.44	108	56537	54299	63378078
Discoloured vomit	26.91	10.44	14	56631	880	63431497
Asthenia	26.86	10.44	486	56159	383118	63049259
Feeling hot	26.59	10.44	102	56543	50252	63382125
Blister	26.47	10.44	47	56598	129767	63302610
Nausea	26.15	10.44	969	55676	853502	62578875
Urticaria thermal	26.08	10.44	11	56634	428	63431949
Constipation	25.15	10.44	309	56336	224634	63207743
Femoral artery dissection	24.49	10.44	6	56639	36	63432341
Headache	24.41	10.44	738	55907	632503	62799874
Low density lipoprotein increased	24.00	10.44	29	56616	6328	63426049
Laboratory test abnormal	23.76	10.44	65	56580	26847	63405530
Plasma cell myeloma	23.47	10.44	78	56567	35827	63396550
Ill-defined disorder	23.42	10.44	23	56622	81732	63350645
Abdominal discomfort	22.40	10.44	181	56464	320704	63111673
Flatulence	22.34	10.44	75	56570	34627	63397750
Injection site pain	21.95	10.44	194	56451	129606	63302771
Product residue present	21.68	10.44	22	56623	3957	63428420
Tremor	21.52	10.44	196	56449	132043	63300334
Eye swelling	21.34	10.44	58	56587	23860	63408517
Intentional overdose	21.08	10.44	21	56624	74131	63358246
Memory impairment	20.94	10.44	162	56483	104096	63328281
Chest pain	20.92	10.44	289	56356	215670	63216707
Cardiac failure congestive	20.47	10.44	147	56498	92286	63340091
Administration site erythema	20.26	10.44	11	56634	754	63431623
Pelvic pain	20.02	10.44	40	56605	13479	63418898
Injection site bruising	19.80	10.44	82	56563	41828	63390549
Swelling face	19.69	10.44	110	56535	63365	63369012
Drug hypersensitivity	19.45	10.44	387	56258	310300	63122077
Impaired healing	19.26	10.44	39	56606	102503	63329874
Insomnia	19.23	10.44	284	56361	214968	63217409
Nervousness	19.10	10.44	66	56579	30913	63401464
Depression	19.05	10.44	263	56382	196229	63236148
Body height decreased	18.90	10.44	33	56612	10045	63422332
Fluid retention	18.89	10.44	104	56541	59582	63372795
Hepatic function abnormal	18.69	10.44	5	56640	37137	63395240
Swelling	18.45	10.44	157	56488	275221	63157156
Type 2 diabetes mellitus	18.25	10.44	18	56627	63850	63368527
Overdose	18.20	10.44	48	56597	115030	63317347
Oedema peripheral	18.11	10.44	253	56392	189258	63243119
Dry skin	17.92	10.44	99	56546	56788	63375589
Injection site haemorrhage	17.87	10.44	55	56590	24259	63408118
Hypoaesthesia	17.40	10.44	228	56417	168165	63264212
Nasal congestion	17.29	10.44	109	56536	65551	63366826
Pneumonia	17.19	10.44	531	56114	456236	62976141
Cyst	16.60	10.44	38	56607	14061	63418316
Atrial fibrillation	16.57	10.44	168	56477	116468	63315909
Coma	16.34	10.44	20	56625	64344	63368033
Sinoatrial block	16.15	10.44	10	56635	878	63431499
Febrile neutropenia	16.13	10.44	53	56592	118396	63313981
Dehydration	15.98	10.44	230	56415	173124	63259253
Hypersensitivity	15.76	10.44	176	56469	292509	63139868
Nocturia	15.72	10.44	27	56618	8114	63424263
Dyspnoea	15.39	10.44	729	55916	660584	62771793
Drug interaction	15.18	10.44	131	56514	229000	63203377
Depressed level of consciousness	15.03	10.44	20	56625	62058	63370319
Hip fracture	14.98	10.44	59	56586	29415	63402962
Dizziness postural	14.95	10.44	25	56620	7351	63425026
Injection site erythema	14.94	10.44	126	56519	83048	63349329
Rhinorrhoea	14.93	10.44	105	56540	65472	63366905
Pain in extremity	14.85	10.44	394	56251	331092	63101285
Injection site reaction	14.69	10.44	96	56549	58428	63373949
Haemoglobin decreased	14.20	10.44	195	56450	145290	63287087
Skin discolouration	14.10	10.44	69	56576	37759	63394618
Blood triglycerides increased	13.98	10.44	33	56612	12455	63419922
Internal haemorrhage	13.97	10.44	20	56625	5145	63427232
Anxiety	13.94	10.44	272	56373	217269	63215108
Interstitial lung disease	13.94	10.44	21	56624	61887	63370490
Chills	13.64	10.44	158	56487	113220	63319157
Erythema	13.46	10.44	226	56419	175525	63256852
Agranulocytosis	13.39	10.44	3	56642	25131	63407246
Urticaria	13.36	10.44	215	56430	165587	63266790
Pulmonary embolism	13.33	10.44	161	56484	116523	63315854
Prescribed overdose	13.18	10.44	7	56638	34146	63398231
Fibromyalgia	13.13	10.44	33	56612	80387	63351990
Red blood cell sedimentation rate increased	13.03	10.44	12	56633	43970	63388407
Pyrexia	13.01	10.44	320	56325	470158	62962219
Drug reaction with eosinophilia and systemic symptoms	12.96	10.44	7	56638	33829	63398548
Influenza like illness	12.95	10.44	103	56542	66721	63365656
Dry eye	12.88	10.44	71	56574	40690	63391687
Vision blurred	12.86	10.44	132	56513	91792	63340585
Dyspnoea exertional	12.83	10.44	95	56550	60207	63372170
Plasma cell myeloma recurrent	12.69	10.44	15	56630	3198	63429179
Infection	12.65	10.44	137	56508	229036	63203341
Gait disturbance	12.40	10.44	231	56414	182947	63249430
Hypervolaemia	12.19	10.44	54	56591	28359	63404018
Foetal exposure during pregnancy	11.69	10.44	7	56638	31955	63400422
Urinary tract infection	11.67	10.44	314	56331	264370	63168007
Altered state of consciousness	11.60	10.44	4	56641	25226	63407151
Adverse event	11.60	10.44	27	56618	67532	63364845
Cholestasis	11.41	10.44	6	56639	29428	63402949
Product complaint	11.37	10.44	31	56614	12778	63419599
Dysgeusia	11.35	10.44	76	56569	46634	63385743
Epilepsy	11.28	10.44	5	56640	27060	63405317
Blood potassium decreased	11.20	10.44	70	56575	41956	63390421
Pigmentation disorder	11.16	10.44	17	56628	4622	63427755
Blood pressure fluctuation	11.13	10.44	15	56630	46302	63386075
Cardio-respiratory arrest	11.09	10.44	23	56622	59936	63372441
Ageusia	10.98	10.44	32	56613	13696	63418681
Tooth disorder	10.96	10.44	52	56593	28105	63404272
Vaginal haemorrhage	10.87	10.44	51	56594	27436	63404941
Cardiac disorder	10.78	10.44	80	56565	50736	63381641
Lactic acidosis	10.70	10.44	11	56634	38276	63394101
Blood glucose decreased	10.70	10.44	42	56603	20910	63411467
Administration site swelling	10.56	10.44	9	56636	1298	63431079

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Flushing	707.48	10.61	463	43220	31957	34881291
Product residue present	178.58	10.61	81	43602	2665	34910583
Off label use	149.99	10.61	183	43500	419341	34493907
Drug abuse	109.84	10.61	3	43680	99093	34814155
Product use in unapproved indication	89.17	10.61	19	43664	117480	34795768
Toxicity to various agents	84.12	10.61	76	43607	200286	34712962
Completed suicide	70.25	10.61	18	43665	98150	34815098
Pruritus	67.62	10.61	353	43330	141628	34771620
Skin burning sensation	59.25	10.61	48	43635	4595	34908653
High density lipoprotein decreased	58.94	10.61	42	43641	3318	34909930
Myalgia	57.78	10.61	233	43450	83877	34829371
General physical health deterioration	51.02	10.61	51	43632	128218	34785030
Asthenia	43.54	10.61	483	43200	244768	34668480
Fatigue	41.77	10.61	672	43011	369981	34543267
Drug interaction	40.27	10.61	146	43537	225800	34687448
Dizziness	39.06	10.61	431	43252	218090	34695158
Myocardial infarction	39.00	10.61	272	43411	120813	34792435
Febrile neutropenia	36.84	10.61	72	43611	136777	34776471
Feeling hot	36.34	10.61	77	43606	19295	34893953
Muscle spasms	36.00	10.61	187	43496	74814	34838434
Blood glucose increased	35.30	10.61	171	43512	66547	34846701
Product dose omission issue	35.13	10.61	263	43420	119448	34793800
Plasma cell myeloma	35.09	10.61	124	43559	41913	34871335
Intentional overdose	33.23	10.61	7	43676	43667	34869581
Product use issue	32.96	10.61	19	43664	63197	34850051
Respiratory tract infection bacterial	32.94	10.61	23	43660	1759	34911489
Coronary artery occlusion	32.43	10.61	53	43630	10909	34902339
Paraesthesia	31.48	10.61	161	43522	64011	34849237
Burning sensation	30.97	10.61	70	43613	18324	34894924
Treatment failure	30.74	10.61	10	43673	46687	34866561
Laboratory test abnormal	29.34	10.61	73	43610	20318	34892930
Rash	28.91	10.61	414	43269	222338	34690910
Fall	28.73	10.61	383	43300	202502	34710746
Interstitial lung disease	28.25	10.61	24	43659	65258	34847990
Respiratory tract infection viral	27.92	10.61	24	43659	2493	34910755
Full blood count decreased	27.35	10.61	66	43617	18022	34895226
Diarrhoea	25.18	10.61	651	43032	389261	34523987
Hepatic function abnormal	25.10	10.61	12	43671	44351	34868897
Low density lipoprotein increased	24.54	10.61	29	43654	4407	34908841
Hypoaesthesia	24.02	10.61	145	43538	61299	34851949
Drug hypersensitivity	23.08	10.61	176	43507	80353	34832895
Coronary artery disease	22.86	10.61	120	43563	48185	34865063
Cardiac failure	22.85	10.61	50	43633	91198	34822050
Leukopenia	22.75	10.61	27	43656	62829	34850419
Renal impairment	22.69	10.61	53	43630	94460	34818788
Intentional product use issue	22.40	10.61	25	43658	59791	34853457
Foetal exposure during pregnancy	22.02	10.61	10	43673	38091	34875157
Drug reaction with eosinophilia and systemic symptoms	21.85	10.61	7	43676	33005	34880243
Blood triglycerides increased	21.77	10.61	52	43631	14107	34899141
Blood testosterone decreased	21.68	10.61	27	43656	4330	34908918
Flatulence	21.68	10.61	67	43616	21131	34892117
Drug ineffective	21.59	10.61	422	43261	456329	34456919
Suicide attempt	21.49	10.61	11	43672	39105	34874143
Condition aggravated	20.62	10.61	148	43535	192048	34721200
Eosinophilia	20.37	10.61	4	43679	26218	34887030
Overdose	19.58	10.61	54	43629	91005	34822243
Blood creatine phosphokinase increased	19.57	10.61	109	43574	44748	34868500
Psoriasis	19.46	10.61	98	43585	38714	34874534
Adverse drug reaction	19.10	10.61	80	43603	29262	34883986
Coma	18.32	10.61	18	43665	45660	34867588
Cardiac disorder	18.29	10.61	104	43579	43022	34870226
Drug resistance	18.06	10.61	5	43678	25922	34887326
Agranulocytosis	17.75	10.61	4	43679	23817	34889431
Urticaria	17.69	10.61	136	43547	62241	34851007
Muscular weakness	17.48	10.61	153	43530	72744	34840504
Contraindicated product administered	17.28	10.61	3	43680	21478	34891770
Cerebrovascular accident	16.84	10.61	171	43512	84640	34828608
Altered state of consciousness	16.75	10.61	4	43679	22889	34890359
Hot flush	16.56	10.61	55	43628	18011	34895237
Viral infection	16.47	10.61	54	43629	17569	34895679
Gastrointestinal haemorrhage	16.43	10.61	176	43507	88301	34824947
Sinusitis	16.36	10.61	98	43585	41304	34871944
Oedema peripheral	16.03	10.61	224	43459	119588	34793660
Multiple organ dysfunction syndrome	16.02	10.61	46	43637	76520	34836728
Therapy cessation	15.85	10.61	52	43631	16921	34896327
Haemoglobin decreased	15.84	10.61	225	43458	120547	34792701
Cardiac failure congestive	15.63	10.61	166	43517	83104	34830144
Thrombosis	15.43	10.61	112	43571	50346	34862902
Dyspepsia	15.20	10.61	88	43595	36644	34876604
Malignant neoplasm progression	14.92	10.61	58	43625	87988	34825260
Cytomegalovirus infection	14.89	10.61	7	43676	26128	34887120
Transaminases abnormal	14.61	10.61	7	43676	261	34912987
Drug dependence	14.56	10.61	6	43677	24211	34889037
Rash pruritic	14.20	10.61	69	43614	26872	34886376
Hepatocellular injury	14.19	10.61	5	43678	22206	34891042
Cholestasis	14.18	10.61	8	43675	26940	34886308
Infusion related reaction	14.18	10.61	28	43655	53029	34860219
Increased tendency to bruise	13.90	10.61	21	43662	4040	34909208
COVID-19	13.85	10.61	50	43633	77500	34835748
Weight decreased	13.64	10.61	302	43381	175999	34737249
Chest pain	13.50	10.61	228	43455	126534	34786714
Neurotoxicity	13.47	10.61	3	43680	18007	34895241
Platelet count decreased	13.36	10.61	217	43466	119500	34793748
Dysgeusia	13.35	10.61	67	43616	26430	34886818
Influenza like illness	13.31	10.61	69	43614	27565	34885683
Therapeutic product effect incomplete	13.23	10.61	27	43656	50514	34862734
Myopathy	13.22	10.61	38	43645	11516	34901732
Mental status changes	13.09	10.61	87	43596	37996	34875252
Septic shock	13.03	10.61	46	43637	71788	34841460
Rash maculo-papular	12.88	10.61	10	43673	28441	34884807
Fluid retention	12.86	10.61	67	43616	26820	34886428
Delirium	12.84	10.61	22	43661	43969	34869279
Feeling abnormal	12.79	10.61	128	43555	63107	34850141
Contusion	12.46	10.61	83	43600	36281	34876967
Muscle fatigue	12.39	10.61	12	43671	1453	34911795
Injury	12.39	10.61	55	43628	20632	34892616
Disseminated intravascular coagulation	12.19	10.61	6	43677	21810	34891438
High density lipoprotein abnormal	12.12	10.61	4	43679	54	34913194
Fibrin D dimer increased	11.85	10.61	20	43663	4224	34909024
Drug eruption	11.85	10.61	5	43678	19893	34893355
Neutropenia	11.84	10.61	132	43551	156646	34756602
Influenza	11.77	10.61	104	43579	49562	34863686
Headache	11.74	10.61	331	43352	200304	34712944
Intentional product misuse	11.41	10.61	25	43658	45586	34867662
White blood cell count decreased	11.40	10.61	175	43508	95270	34817978
Myelosuppression	11.22	10.61	5	43678	19260	34893988
Drug ineffective for unapproved indication	11.16	10.61	8	43675	23707	34889541
Application site exfoliation	11.12	10.61	5	43678	161	34913087
Erythema	11.08	10.61	164	43519	88616	34824632
Unevaluable event	10.93	10.61	74	43609	32516	34880732
Back pain	10.84	10.61	213	43470	121576	34791672
Neoplasm progression	10.79	10.61	8	43675	23292	34889956
Abdominal discomfort	10.63	10.61	118	43565	59717	34853531

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Off label use	182.15	10.06	363	74717	906852	78762456
Completed suicide	157.92	10.06	22	75058	245745	79423563
Product use in unapproved indication	140.09	10.06	32	75048	250327	79418981
Flushing	139.84	10.06	277	74803	87991	79581317
Drug abuse	134.74	10.06	4	75076	162687	79506621
Synovitis	127.48	10.06	3	75077	150731	79518577
Toxicity to various agents	121.15	10.06	131	74949	421409	79247899
Contraindicated product administered	111.48	10.06	10	75070	157528	79511780
Treatment failure	98.99	10.06	20	75060	170466	79498842
Product dose omission issue	88.23	10.06	463	74617	247074	79422234
Hand deformity	84.45	10.06	3	75077	103916	79565392
Drug intolerance	81.60	10.06	77	75003	264042	79405266
Drug ineffective	80.87	10.06	642	74438	1080271	78589037
Infusion related reaction	79.87	10.06	60	75020	230177	79439131
Fall	72.41	10.06	739	74341	486890	79182418
Product use issue	72.36	10.06	55	75025	209767	79459541
Dizziness	69.86	10.06	780	74300	525661	79143647
General physical health deterioration	68.99	10.06	95	74985	275143	79394165
Myalgia	65.26	10.06	346	74734	185295	79484013
Muscle spasms	65.11	10.06	331	74749	174399	79494909
Systemic lupus erythematosus	62.89	10.06	18	75062	121131	79548177
Therapy cessation	58.39	10.06	117	74963	37445	79631863
Asthenia	54.31	10.06	727	74353	510962	79158346
Maternal exposure during pregnancy	53.52	10.06	31	75049	136507	79532801
Pericarditis	53.16	10.06	16	75064	104220	79565088
Lower respiratory tract infection	52.59	10.06	28	75052	129192	79540116
Glossodynia	52.46	10.06	16	75064	103321	79565987
Device expulsion	52.04	10.06	90	74990	25771	79643537
Plasma cell myeloma	46.93	10.06	133	74947	53126	79616182
Therapeutic product effect incomplete	46.47	10.06	39	75041	141606	79527702
Duodenal ulcer perforation	42.31	10.06	6	75074	66205	79603103
Fatigue	42.21	10.06	1159	73921	928568	78740740
Cardiac failure congestive	41.19	10.06	252	74828	142150	79527158
Diarrhoea	40.06	10.06	1098	73982	879391	78789917
Intentional product use issue	39.61	10.06	51	75029	152061	79517247
Drug interaction	39.09	10.06	230	74850	414953	79254355
Helicobacter infection	38.77	10.06	9	75071	69695	79599613
Intentional overdose	37.51	10.06	27	75053	105933	79563375
Myocardial infarction	37.44	10.06	299	74781	183830	79485478
Coronary artery disease	37.35	10.06	141	74939	65333	79603975
Respiratory tract infection bacterial	35.65	10.06	23	75057	2054	79667254
Haemoglobin decreased	34.97	10.06	341	74739	221778	79447530
Deep vein thrombosis	34.34	10.06	213	74867	120706	79548602
Full blood count decreased	34.12	10.06	77	75003	26742	79642566
Fluid retention	33.15	10.06	142	74938	69667	79599641
Hepatic function abnormal	32.56	10.06	14	75066	73093	79596215
Joint swelling	32.13	10.06	151	74929	288495	79380813
Blood triglycerides increased	32.06	10.06	65	75015	20975	79648333
Condition aggravated	31.79	10.06	310	74770	500814	79168494
Rheumatoid arthritis	31.69	10.06	96	74984	208374	79460934
Coma	31.45	10.06	29	75051	100620	79568688
Wound	31.24	10.06	38	75042	116141	79553167
Febrile neutropenia	31.23	10.06	112	74968	230887	79438421
COVID-19	30.65	10.06	64	75016	157610	79511698
Dehydration	29.37	10.06	360	74720	247827	79421481
Dyspnoea exertional	29.01	10.06	160	74920	86913	79582395
Interstitial lung disease	28.04	10.06	39	75041	112561	79556747
C-reactive protein increased	28.03	10.06	49	75031	128978	79540330
Overdose	27.87	10.06	85	74995	184121	79485187
Drug reaction with eosinophilia and systemic symptoms	27.51	10.06	13	75067	64231	79605077
Unevaluable event	27.12	10.06	114	74966	55471	79613837
Intentional product misuse	26.80	10.06	30	75050	95135	79574173
Hepatocellular injury	26.76	10.06	6	75074	47587	79621721
Arthropathy	26.60	10.06	82	74998	177029	79492279
High density lipoprotein decreased	26.48	10.06	27	75053	4628	79664680
Feeling abnormal	26.33	10.06	247	74833	158952	79510356
Chest pain	25.82	10.06	391	74689	281913	79387395
Folliculitis	25.64	10.06	10	75070	55370	79613938
Coronary artery occlusion	25.37	10.06	49	75031	15266	79654042
Urticaria thermal	25.37	10.06	11	75069	434	79668874
International normalised ratio increased	25.17	10.06	151	74929	84570	79584738
Myelosuppression	24.95	10.06	4	75076	40292	79629016
Respiratory tract infection viral	24.77	10.06	25	75055	4234	79665074
Agranulocytosis	24.67	10.06	6	75074	45024	79624284
Flatulence	24.35	10.06	92	74988	42632	79626676
Oedema peripheral	24.07	10.06	352	74728	251936	79417372
Device dislocation	24.00	10.06	66	75014	25904	79643404
Administration site erythema	23.89	10.06	10	75070	361	79668947
Mental status changes	23.63	10.06	125	74955	66834	79602474
Femoral artery dissection	23.02	10.06	6	75074	45	79669263
Low density lipoprotein increased	22.82	10.06	34	75046	8588	79660720
Therapeutic product effect decreased	22.44	10.06	79	75001	163784	79505524
Irritable bowel syndrome	21.84	10.06	16	75064	62225	79607083
Cardiac disorder	21.35	10.06	120	74960	65637	79603671
Eosinophilia	21.30	10.06	8	75072	45337	79623971
Dyspnoea	21.28	10.06	998	74082	856027	78813281
Pelvic pain	21.18	10.06	42	75038	13339	79655969
Blood glucose increased	20.85	10.06	182	74898	114793	79554515
Drug resistance	20.60	10.06	7	75073	42206	79627102
Depression	20.49	10.06	302	74778	216488	79452820
Leukopenia	20.44	10.06	50	75030	116463	79552845
Hypervolaemia	20.39	10.06	87	74993	42603	79626705
Renal impairment	20.34	10.06	78	75002	157705	79511603
Cholestasis	20.17	10.06	12	75068	52097	79617211
Altered state of consciousness	20.14	10.06	8	75072	43814	79625494
Nausea	20.14	10.06	1097	73983	956099	78713209
Nasal congestion	19.97	10.06	132	74948	76420	79592888
Discoloured vomit	19.71	10.06	14	75066	1464	79667844
Eye swelling	19.44	10.06	62	75018	26406	79642902
Cytomegalovirus infection	19.25	10.06	8	75072	42636	79626672
Dizziness postural	19.19	10.06	37	75043	11512	79657796
Depressed level of consciousness	18.97	10.06	39	75041	96613	79572695
Injection site pain	18.81	10.06	196	74884	129642	79539666
Dysgeusia	18.34	10.06	104	74976	57073	79612235
Cerebrovascular accident	18.24	10.06	225	74855	155067	79514241
Gastrointestinal haemorrhage	18.21	10.06	216	74864	147503	79521805
Pulmonary embolism	18.18	10.06	244	74836	171410	79497898
Back pain	18.15	10.06	394	74686	303786	79365522
Blood testosterone decreased	17.71	10.06	16	75064	2361	79666947
Suicide attempt	17.55	10.06	32	75048	82900	79586408
Rotator cuff syndrome	17.41	10.06	40	75040	14055	79655253
Thrombosis	17.31	10.06	137	74943	83963	79585345
Tremor	17.29	10.06	240	74840	169843	79499465
Rheumatic fever	17.29	10.06	3	75077	28522	79640786
Exposure during pregnancy	17.27	10.06	44	75036	101088	79568220
Neoplasm progression	17.23	10.06	14	75066	51668	79617640
Influenza like illness	17.13	10.06	121	74959	71586	79597722
Hospice care	17.06	10.06	33	75047	10291	79659017
Psoriasis	16.86	10.06	143	74937	89444	79579864
Haematocrit decreased	16.77	10.06	107	74973	61205	79608103
Blister	16.76	10.06	57	75023	119419	79549889
Injection site haemorrhage	16.71	10.06	61	75019	27809	79641499
Hepatic enzyme increased	16.71	10.06	102	74978	182508	79486800
Small intestinal obstruction	16.61	10.06	60	75020	27212	79642096
Hip fracture	16.52	10.06	65	75015	30696	79638612
Epilepsy	16.40	10.06	9	75071	40851	79628457
Viral infection	16.36	10.06	82	74998	42934	79626374
Weight decreased	16.34	10.06	444	74636	354754	79314554
Discomfort	16.25	10.06	62	75018	125555	79543753
Ill-defined disorder	16.22	10.06	23	75057	65852	79603456
Hypoaesthesia	15.84	10.06	247	74833	179105	79490203
Drug eruption	15.80	10.06	11	75069	43924	79625384
Liver injury	15.77	10.06	18	75062	56596	79612712
Alopecia	15.54	10.06	141	74939	231214	79438094
Pneumonia	15.32	10.06	764	74316	659482	79009826
Fibromyalgia	15.31	10.06	23	75057	64317	79604991
Burning sensation	15.23	10.06	101	74979	58531	79610777
Multiple organ dysfunction syndrome	15.14	10.06	60	75020	120186	79549122
Feeling hot	14.98	10.06	102	74978	59632	79609676
Toxic epidermal necrolysis	14.95	10.06	12	75068	44569	79624739
Myopathy	14.95	10.06	48	75032	20515	79648793
Headache	14.86	10.06	755	74325	653017	79016291
Neurotoxicity	14.84	10.06	6	75074	32512	79636796
Intentional self-injury	14.77	10.06	6	75074	32413	79636895
Skin burning sensation	14.59	10.06	36	75044	13236	79656072
Labelled drug-drug interaction medication error	14.54	10.06	4	75076	27646	79641662
Respiratory depression	14.53	10.06	4	75076	27626	79641682
Stomatitis	14.48	10.06	80	75000	146677	79522631
Product complaint	14.46	10.06	36	75044	13313	79655995
Cardio-respiratory arrest	14.40	10.06	53	75027	108457	79560851
Rash maculo-papular	14.39	10.06	19	75061	56059	79613249
Anaphylactic shock	14.35	10.06	8	75072	35988	79633320
Aspartate aminotransferase increased	14.23	10.06	196	74884	138445	79530863
Neutropenic sepsis	14.08	10.06	4	75076	27060	79642248
Hypoacusis	14.06	10.06	61	75019	30089	79639219
Blood glucose decreased	13.74	10.06	55	75025	26179	79643129
Bone marrow failure	13.44	10.06	17	75063	51090	79618218
Injection site bruising	13.42	10.06	75	75005	40927	79628381
Neuropathy peripheral	13.40	10.06	197	74883	141108	79528200
Lymphopenia	13.37	10.06	6	75074	30551	79638757
Lactic acidosis	13.30	10.06	29	75051	70330	79598978
Pneumocystis jirovecii pneumonia	13.28	10.06	7	75073	32501	79636807
Multiple sclerosis relapse	13.22	10.06	82	74998	46451	79622857
Influenza	13.21	10.06	183	74897	129423	79539885
Memory impairment	13.16	10.06	162	74918	111572	79557736
Chills	13.14	10.06	218	74862	160016	79509292
Internal haemorrhage	13.11	10.06	27	75053	8806	79660502
Therapeutic response decreased	13.10	10.06	27	75053	66826	79602482
Infection	13.08	10.06	155	74925	241557	79427751
Muscular weakness	12.94	10.06	218	74862	160511	79508797
Nervousness	12.92	10.06	64	75016	33351	79635957
Sedation	12.89	10.06	18	75062	51877	79617431
Serotonin syndrome	12.89	10.06	14	75066	45013	79624295
Pain in extremity	12.83	10.06	441	74639	364097	79305211
Cellulitis	12.79	10.06	158	74922	108902	79560406
Post procedural haemorrhage	12.77	10.06	35	75045	13709	79655599
Mitral valve repair	12.75	10.06	6	75074	287	79669021
Blood potassium decreased	12.62	10.06	81	74999	46431	79622877
Occult blood positive	12.62	10.06	23	75057	6860	79662448
Laboratory test abnormal	12.51	10.06	56	75024	27992	79641316
Muscle fatigue	12.51	10.06	16	75064	3503	79665805
Gait disturbance	12.44	10.06	269	74811	207237	79462071
Blood pressure fluctuation	12.42	10.06	28	75052	67117	79602191
Red blood cell sedimentation rate increased	12.37	10.06	15	75065	45927	79623381
Paraesthesia	12.37	10.06	234	74846	176089	79493219
Atrial fibrillation	12.34	10.06	258	74822	197628	79471680
Vision blurred	12.24	10.06	153	74927	105745	79563563
Platelet count decreased	12.20	10.06	254	74826	194410	79474898
Electrocardiogram QT prolonged	12.09	10.06	44	75036	90342	79578966
Transient ischaemic attack	12.05	10.06	88	74992	52607	79616701
Radioisotope scan abnormal	11.99	10.06	7	75073	523	79668785
Complication associated with device	11.96	10.06	40	75040	17456	79651852
Haemodialysis	11.95	10.06	41	75039	18127	79651181
Sinoatrial block	11.89	10.06	10	75070	1341	79667967
Scratch	11.76	10.06	25	75055	8338	79660970
Insomnia	11.70	10.06	308	74772	244862	79424446
Blood creatine phosphokinase increased	11.66	10.06	104	74976	65986	79603322
Disseminated intravascular coagulation	11.59	10.06	10	75070	35832	79633476
Asthma	11.56	10.06	77	75003	135018	79534290
Drug ineffective for unapproved indication	11.54	10.06	19	75061	51219	79618089
Rhabdomyolysis	11.50	10.06	148	74932	102983	79566325
Body height decreased	11.32	10.06	25	75055	8555	79660753
Rash pruritic	11.27	10.06	110	74970	71519	79597789
Very low density lipoprotein increased	11.24	10.06	5	75075	210	79669098
Constipation	11.14	10.06	347	74733	282703	79386605
Transaminases abnormal	11.12	10.06	8	75072	854	79668454
Poisoning	11.00	10.06	5	75075	25267	79644041
Failure to thrive	10.84	10.06	30	75050	11814	79657494
Blood pressure systolic increased	10.79	10.06	30	75050	66956	79602352
Left atrial dilatation	10.68	10.06	14	75066	3139	79666169
Anxiety	10.68	10.06	308	74772	248204	79421104
Sinus headache	10.64	10.06	18	75062	5062	79664246
Mucosal inflammation	10.64	10.06	36	75044	75544	79593764
Accidental overdose	10.58	10.06	13	75067	39568	79629740
Atelectasis	10.56	10.06	59	75021	32198	79637110
Swelling face	10.55	10.06	108	74972	71104	79598204
Septic shock	10.51	10.06	70	75010	122731	79546577
Bronchitis	10.44	10.06	177	74903	130467	79538841
Meniscus injury	10.42	10.06	21	75059	6747	79662561
Injection site erythema	10.37	10.06	116	74964	78081	79591227
Pulmonary hypertension	10.27	10.06	79	75001	48001	79621307
Lymphocyte count decreased	10.23	10.06	18	75062	47271	79622037
Skin laceration	10.17	10.06	54	75026	28908	79640400
Ventricular hypertrophy	10.06	10.06	21	75059	6917	79662391

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C04AC01	CARDIOVASCULAR SYSTEM PERIPHERAL VASODILATORS PERIPHERAL VASODILATORS Nicotinic acid and derivatives
ATC	C10AD02	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN Nicotinic acid and derivatives
ATC	C10AD52	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN Nicotinic acid and derivatives
ATC	C10BA01	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
FDA CS	M0014839	Nicotinic Acids
FDA EPC	N0000175594	Nicotinic Acid
MeSH PA	D000963	Antimetabolites
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D000960	Hypolipidemic Agents
MeSH PA	D057847	Lipid Regulating Agents
MeSH PA	D018977	Micronutrients
MeSH PA	D014665	Vasodilator Agents
MeSH PA	D014803	Vitamin B Complex
MeSH PA	D014815	Vitamins
CHEBI has role	CHEBI:25212	metabolites
CHEBI has role	CHEBI:35620	vasodilator agents
CHEBI has role	CHEBI:35679	antilipemic drugs
CHEBI has role	CHEBI:50247	antidotes
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:76924	plant metabolites
CHEBI has role	CHEBI:76971	Escherichia coli metabolites
CHEBI has role	CHEBI:84087	human urinary metabolites
CHEBI has role	CHEBI:84264	nicotinamide deaminase inhibitors
CHEBI has role	CHEBI:22586	antioxidants
CHEBI has role	CHEBI:23357	cofactor
CHEBI has role	CHEBI:61115	histone deacetylase inhibitors
CHEBI has role	CHEBI:62913	PARP
CHEBI has role	CHEBI:63726	neuroprotective agents
CHEBI has role	CHEBI:67079	anti-inflammatory agents
CHEBI has role	CHEBI:71181	Sir2 inhibitors
CHEBI has role	CHEBI:75772	S. cerevisiae metabolites
CHEBI has role	CHEBI:176497	geroprotectors

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Hypercholesterolemia	indication	13644009
Hyperlipidemia	indication	55822004	DOID:1168
Vitamin deficiency	indication	85670002
Familial hypercholesterolemia - heterozygous	indication	238079002
Mixed hyperlipidemia	indication	267434003
Hypertriglyceridemia	indication	302870006

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.31	acidic
pKa2	4.85	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Hydroxycarboxylic acid receptor 2	GPCR	Q8TDS4	HCAR2_HUMAN	AGONIST	Ki	7.30	CHEMBL	SCIENTIFIC LITERATURE
Nicotinamide N-methyltransferase	Enzyme	P40261	NNMT_HUMAN				WOMBAT-PK
Nicotinate-nucleotide pyrophosphorylase [carboxylating]	Enzyme	Q15274	NADC_HUMAN				WOMBAT-PK
Nicotinamide phosphoribosyltransferase	Enzyme	P43490	NAMPT_HUMAN				WOMBAT-PK
Hydroxycarboxylic acid receptor 3	GPCR	P49019	HCAR3_HUMAN	AGONIST	EC50	6.52	IUPHAR
Amyloid beta A4 protein	Unclassified	P05067	A4_HUMAN		IC50	4.88	CHEMBL
Hydroxycarboxylic acid receptor 2	GPCR		HCAR2_MOUSE		IC50	6.85	CHEMBL
Hydroxycarboxylic acid receptor 2	GPCR		HCAR2_RAT		Ki	7.48	CHEMBL

External reference:

ID	Source
4019440	VUID
N0000147570	NUI
D00049	KEGG_DRUG
4017632	VANDF
4017661	VANDF
4017718	VANDF
4019440	VANDF
4020285	VANDF
4021898	VANDF
C0027996	UMLSCUI
CHEBI:15940	CHEBI
NIO	PDB_CHEM_ID
CHEMBL573	ChEMBL_ID
938	PUBCHEM_CID
DB00627	DRUGBANK_ID
1588	IUPHAR_LIGAND_ID
218728	RXNORM
2275	MMSL
4947	MMSL
5169	MMSL
5170	MMSL
5684	MMSL
7159	MMSL
7161	MMSL
72420	MMSL
d00314	MMSL
d03739	MMSL
001052	NDDF
001055	NDDF
173196005	SNOMEDCT_US
273943001	SNOMEDCT_US
63639004	SNOMEDCT_US
D009525	MESH_DESCRIPTOR_UI
373	INN_ID
2679MF687A	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3074	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	NDA	29 sections
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3074	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	NDA	29 sections
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3079	TABLET, FILM COATED, EXTENDED RELEASE	750 mg	ORAL	NDA	29 sections
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3079	TABLET, FILM COATED, EXTENDED RELEASE	750 mg	ORAL	NDA	29 sections
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3080	TABLET, FILM COATED, EXTENDED RELEASE	1000 mg	ORAL	NDA	29 sections
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3080	TABLET, FILM COATED, EXTENDED RELEASE	1000 mg	ORAL	NDA	29 sections
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3265	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	NDA	29 sections
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3265	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	NDA	29 sections
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3274	TABLET, FILM COATED, EXTENDED RELEASE	750 mg	ORAL	NDA	29 sections
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3274	TABLET, FILM COATED, EXTENDED RELEASE	750 mg	ORAL	NDA	29 sections
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3275	TABLET, FILM COATED, EXTENDED RELEASE	1000 mg	ORAL	NDA	29 sections
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3275	TABLET, FILM COATED, EXTENDED RELEASE	1000 mg	ORAL	NDA	29 sections
VitafolOne	HUMAN PRESCRIPTION DRUG LABEL	16	0642-0070	CAPSULE, GELATIN COATED	15 mg	ORAL	unapproved drug other	14 sections
Vitafol Caplet	HUMAN PRESCRIPTION DRUG LABEL	12	0642-0072	CAPSULE	15 mg	ORAL	UNAPPROVED DRUG OTHER	13 sections
Select OB	HUMAN PRESCRIPTION DRUG LABEL	15	0642-0077	TABLET, CHEWABLE	15 mg	ORAL	UNAPPROVED DRUG OTHER	14 sections
Vitafol OB Caplet	HUMAN PRESCRIPTION DRUG LABEL	15	0642-0079	TABLET	18 mg	ORAL	Unapproved drug other	14 sections
Vitafol OB Caplet	HUMAN PRESCRIPTION DRUG LABEL	15	0642-0079	TABLET	18 mg	ORAL	Unapproved drug other	14 sections
Vitafol Plus	HUMAN PRESCRIPTION DRUG LABEL	17	0642-0092	CAPSULE, LIQUID FILLED	15 mg	ORAL	UNAPPROVED DRUG OTHER	13 sections
Strovite Forte Caplet	HUMAN PRESCRIPTION DRUG LABEL	19	0642-0204	TABLET, COATED	100 mg	ORAL	UNAPPROVED DRUG OTHER	15 sections
Reaphirm Plant Source DHA	HUMAN PRESCRIPTION DRUG LABEL	16	0642-3010	CAPSULE, GELATIN COATED	15 mg	ORAL	unapproved drug other	7 sections
O-Cal Prenatal Vitamin	HUMAN PRESCRIPTION DRUG LABEL	16	0813-0202	TABLET	17 mg	ORAL	UNAPPROVED DRUG OTHER	6 sections
Niacin	HUMAN PRESCRIPTION DRUG LABEL	1	10135-612	TABLET, EXTENDED RELEASE	500 mg	ORAL	ANDA	25 sections
Niacin	HUMAN PRESCRIPTION DRUG LABEL	1	10135-613	TABLET, EXTENDED RELEASE	750 mg	ORAL	ANDA	25 sections
Niacin	HUMAN PRESCRIPTION DRUG LABEL	1	10135-614	TABLET, EXTENDED RELEASE	1000 mg	ORAL	ANDA	25 sections
TriStart DHA	HUMAN PRESCRIPTION DRUG LABEL	15	15370-250	CAPSULE, LIQUID FILLED	5 mg	ORAL	UNAPPROVED DRUG OTHER	12 sections
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	21695-852	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	NDA	26 sections
Niaspan	HUMAN PRESCRIPTION DRUG LABEL	1	21695-865	TABLET, FILM COATED, EXTENDED RELEASE	1000 mg	ORAL	NDA	26 sections
Niacin	Human Prescription Drug Label	1	33342-187	TABLET	500 mg	ORAL	ANDA	25 sections
Niacin	Human Prescription Drug Label	1	33342-189	TABLET	1000 mg	ORAL	ANDA	25 sections
NIACIN	Human Prescription Drug Label	1	47335-539	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	ANDA	27 sections