ezetimibe Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antihyperlipidaemics, acyl CoA: cholesterol acyltransferase (ACAT) inhibitors	1125	163222-33-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: SCH58235 SCH-58235 ezetimib ezetimibe ezedoc ezentia ezetrol zetia	An azetidine derivative and ANTICHOLESTEREMIC AGENT that inhibits intestinal STEROL absorption. It is used to reduce total CHOLESTEROL; LDL CHOLESTEROL, and APOLIPOPROTEINS B in the treatment of HYPERLIPIDEMIAS. Molecular weight: 409.43 Formula: C24H21F2NO3 CLOGP: 3.96 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 60.77 ALOGS: -4.68 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

SCH58235
SCH-58235
ezetimib
ezetimibe
ezedoc
ezentia
ezetrol
zetia

An azetidine derivative and ANTICHOLESTEREMIC AGENT that inhibits intestinal STEROL absorption. It is used to reduce total CHOLESTEROL; LDL CHOLESTEROL, and APOLIPOPROTEINS B in the treatment of HYPERLIPIDEMIAS.

Molecular weight: 409.43
Formula: C24H21F2NO3
CLOGP: 3.96
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 60.77
ALOGS: -4.68
ROTB: 6

Status: OFP

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

Drug dosage:

Dose	Unit	Route
10	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	2 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.35 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Oct. 25, 2002	FDA	MSD INTL GMBH
April 18, 2007	PMDA	Schering-Plough K.K

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
Myalgia	794.77	10.38	881	62294	132610	53153281
Rhabdomyolysis	664.82	10.38	491	62684	43432	53242459
Blood creatine phosphokinase increased	309.33	10.38	264	62911	28721	53257170
Low density lipoprotein increased	217.74	10.38	118	63057	6048	53279843
Contraindicated product administered	131.87	10.38	7	63168	135622	53150269
Muscle spasms	123.87	10.38	396	62779	134399	53151492
Maternal exposure during pregnancy	117.90	10.38	21	63154	155618	53130273
Myopathy	117.32	10.38	95	63080	9597	53276294
Pemphigus	109.16	10.38	3	63172	104028	53181863
Rheumatoid arthritis	107.15	10.38	129	63046	314402	52971489
Drug ineffective	105.54	10.38	555	62620	816690	52469201
Coronary artery disease	101.75	10.38	159	63016	33278	53252613
Synovitis	100.55	10.38	7	63168	107886	53178005
Muscular weakness	97.61	10.38	302	62873	100690	53185201
Myocardial infarction	95.93	10.38	297	62878	99057	53186834
Angina pectoris	93.60	10.38	141	63034	28584	53257307
Pancreatitis acute	93.51	10.38	134	63041	25975	53259916
Liver function test abnormal	87.75	10.38	183	62992	47888	53238003
Toxicity to various agents	81.37	10.38	84	63091	219514	53066377
Infusion related reaction	80.64	10.38	42	63133	155915	53129976
Acute kidney injury	79.14	10.38	543	62632	253325	53032566
Pain in extremity	78.08	10.38	591	62584	284459	53001432
Death	69.17	10.38	206	62969	357026	52928865
Off label use	68.61	10.38	307	62868	471905	52813986
Pancreatitis	65.56	10.38	159	63016	45983	53239908
Wound	63.82	10.38	15	63160	91542	53194349
Exposure during pregnancy	62.53	10.38	35	63140	124825	53161066
Coronary artery occlusion	62.13	10.38	62	63113	8225	53277666
Treatment failure	61.46	10.38	38	63137	128365	53157526
Completed suicide	60.67	10.38	45	63130	138156	53147735
Hyper IgE syndrome	58.05	10.38	21	63154	400	53285491
Product use issue	58.05	10.38	48	63127	139536	53146355
Blood cholesterol increased	57.36	10.38	165	63010	52824	53233067
Hyperlipidaemia	56.87	10.38	91	63084	19424	53266467
Acute coronary syndrome	55.35	10.38	65	63110	10359	53275532
Pericarditis	55.05	10.38	6	63169	64400	53221491
Glossodynia	51.84	10.38	27	63148	100264	53185627
Aspartate aminotransferase increased	51.03	10.38	216	62959	83813	53202078
High density lipoprotein decreased	50.19	10.38	30	63145	1855	53284036
Systemic lupus erythematosus	49.87	10.38	45	63130	125369	53160522
Alanine aminotransferase increased	49.14	10.38	233	62942	94862	53191029
Arterial stenosis	48.65	10.38	21	63154	647	53285244
Blood glucose increased	47.86	10.38	200	62975	77161	53208730
Blood triglycerides increased	46.23	10.38	65	63110	12376	53273515
Vascular stent stenosis	45.61	10.38	19	63156	535	53285356
Intentional overdose	44.92	10.38	12	63163	67193	53218698
Drug abuse	43.23	10.38	12	63163	65514	53220377
Therapeutic product effect decreased	42.20	10.38	52	63123	125603	53160288
Flatulence	42.01	10.38	106	63069	31411	53254480
Dyslipidaemia	41.40	10.38	44	63131	6283	53279608
Joint swelling	40.01	10.38	143	63032	234495	53051396
Carotid arteriosclerosis	39.66	10.38	21	63154	1026	53284865
Polymyositis	39.15	10.38	25	63150	1739	53284152
Dizziness	39.00	10.38	638	62537	371621	52914270
Infection	38.79	10.38	92	63083	172113	53113778
Immune-mediated myositis	38.58	10.38	21	63154	1085	53284806
Cardiac failure congestive	37.99	10.38	213	62962	92544	53193347
Febrile neutropenia	36.76	10.38	42	63133	104894	53180997
Arterial occlusive disease	36.43	10.38	37	63138	5012	53280879
Restrictive pulmonary disease	34.36	10.38	22	63153	1537	53284354
Coombs positive haemolytic anaemia	34.23	10.38	14	63161	376	53285515
Sensorimotor disorder	34.13	10.38	15	63160	483	53285408
Myositis	34.05	10.38	46	63129	8437	53277454
Angina unstable	33.86	10.38	43	63132	7425	53278466
Pyrexia	33.79	10.38	310	62865	402883	52883008
Muscle rupture	33.60	10.38	25	63150	2229	53283662
Antinuclear antibody negative	33.20	10.38	12	63163	228	53285663
Muscle disorder	32.01	10.38	33	63142	4548	53281343
Crush syndrome	31.74	10.38	10	63165	122	53285769
Asthenia	31.67	10.38	577	62598	343013	52942878
Swelling	31.56	10.38	118	63057	190987	53094904
Myopathy toxic	30.16	10.38	13	63162	399	53285492
Lipids increased	29.83	10.38	18	63157	1132	53284759
Cerebrovascular accident	29.22	10.38	219	62956	104955	53180936
Chest pain	28.77	10.38	348	62827	189837	53096054
Disease progression	28.48	10.38	48	63127	101872	53184019
Neutropenia	28.48	10.38	95	63080	159090	53126801
Duodenal ulcer perforation	28.30	10.38	4	63171	35179	53250712
Hyperkalaemia	28.06	10.38	133	63042	54123	53231768
Palpitations	27.81	10.38	212	62963	102136	53183755
Herpes simplex reactivation	27.79	10.38	12	63163	370	53285521
Hypoglycaemia	27.20	10.38	140	63035	58873	53227018
Inhibitory drug interaction	26.77	10.38	22	63153	2268	53283623
Body tinea	26.60	10.38	17	63158	1184	53284707
Gangrene	25.21	10.38	30	63145	4847	53281044
Aortic stenosis	25.14	10.38	29	63146	4534	53281357
Transient ischaemic attack	24.99	10.38	96	63079	35629	53250262
Polycystic ovaries	24.81	10.38	21	63154	2255	53283636
Microscopic polyangiitis	24.76	10.38	9	63166	174	53285717
Glucose tolerance impaired	24.70	10.38	31	63144	5289	53280602
Coma acidotic	23.52	10.38	8	63167	126	53285765
Lower respiratory tract infection	23.48	10.38	45	63130	90936	53194955
Arthropathy	22.91	10.38	88	63087	141365	53144526
Gait disturbance	22.87	10.38	288	62887	158554	53127337
Device expulsion	22.60	10.38	4	63171	29809	53256082
Ischaemic cardiomyopathy	22.35	10.38	21	63154	2587	53283304
Pregnancy	22.20	10.38	5	63170	31436	53254455
Cardiac valve disease	21.48	10.38	26	63149	4276	53281615
Renovascular hypertension	21.31	10.38	5	63170	17	53285874
Coronary artery thrombosis	21.12	10.38	15	63160	1244	53284647
Depressed level of consciousness	21.06	10.38	20	63155	54408	53231483
Blood cholesterol decreased	21.01	10.38	11	63164	525	53285366
Helicobacter infection	20.96	10.38	10	63165	39059	53246832
Fall	20.64	10.38	563	62612	357877	52928014
Coronary artery stenosis	20.50	10.38	27	63148	4832	53281059
Lipids abnormal	20.42	10.38	9	63166	292	53285599
Intentional product use issue	20.38	10.38	34	63141	72460	53213431
Back pain	20.37	10.38	390	62785	233857	53052034
Copper metabolism disorder	20.19	10.38	4	63171	4	53285887
Biliary fibrosis	20.19	10.38	4	63171	4	53285887
Peripheral artery haematoma	19.86	10.38	6	63169	63	53285828
Acute myocardial infarction	19.82	10.38	85	63090	33150	53252741
Pain	19.59	10.38	539	62636	587859	52698032
Chest discomfort	19.48	10.38	192	62983	99503	53186388
Abortion spontaneous	19.42	10.38	16	63159	46619	53239272
Pancytopenia	19.35	10.38	50	63125	90878	53195013
Vascular purpura	19.31	10.38	15	63160	1426	53284465
Sleep disorder due to general medical condition, insomnia type	19.05	10.38	3	63172	24346	53261545
Spontaneous haematoma	19.05	10.38	12	63163	815	53285076
Sepsis	18.96	10.38	99	63076	146330	53139561
Gastritis haemorrhagic	18.92	10.38	15	63160	1469	53284422
Nasopharyngitis	18.71	10.38	142	63033	192153	53093738
Obstructive pancreatitis	18.64	10.38	8	63167	243	53285648
Blood glucose decreased	18.52	10.38	59	63116	19957	53265934
Foetal exposure during pregnancy	18.45	10.38	9	63166	34706	53251185
Device dislocation	18.25	10.38	3	63172	23594	53262297
Toxic epidermal necrolysis	18.20	10.38	3	63172	23547	53262344
Lipoprotein (a) increased	17.99	10.38	5	63170	38	53285853
Diabetic neuropathy	17.96	10.38	23	63152	4004	53281887
Muscle discomfort	17.79	10.38	6	63169	92	53285799
Abnormal dreams	17.77	10.38	39	63136	10562	53275329
Depression	17.74	10.38	310	62865	182742	53103149
Intestinal transit time abnormal	17.73	10.38	6	63169	93	53285798
Total cholesterol/HDL ratio decreased	17.43	10.38	4	63171	12	53285879
Alopecia	17.25	10.38	186	62989	234397	53051494
Carotid artery stenosis	17.13	10.38	26	63149	5301	53280590
Therapy cessation	16.96	10.38	72	63103	27953	53257938
Paresis	16.93	10.38	17	63158	2272	53283619
C-reactive protein abnormal	16.58	10.38	5	63170	25865	53260026
Respiratory disorder	16.43	10.38	10	63165	34087	53251804
Euglycaemic diabetic ketoacidosis	16.38	10.38	19	63156	2988	53282903
Gastric disorder	16.37	10.38	75	63100	30090	53255801
Congenital musculoskeletal anomaly	16.24	10.38	9	63166	482	53285409
Restless legs syndrome	16.15	10.38	51	63124	17172	53268719
Oedema peripheral	16.11	10.38	288	62887	170499	53115392
Low density lipoprotein decreased	16.09	10.38	7	63168	220	53285671
Gastrooesophageal reflux disease	16.05	10.38	159	63016	82504	53203387
Hyperphosphataemia	15.96	10.38	16	63159	2133	53283758
Cell death	15.82	10.38	17	63158	2458	53283433
Disease risk factor	15.72	10.38	5	63170	63	53285828
Product use in unapproved indication	15.63	10.38	74	63101	112215	53173676
Hepatic cyst	15.53	10.38	24	63151	4972	53280919
Infection susceptibility increased	15.47	10.38	17	63158	2520	53283371
Spleen congestion	15.07	10.38	6	63169	150	53285741
Hyperparathyroidism secondary	14.75	10.38	13	63162	1474	53284417
Chromaturia	14.74	10.38	47	63128	15903	53269988
Stomatitis	14.67	10.38	63	63112	98095	53187796
Anembryonic gestation	14.58	10.38	9	63166	590	53285301
Troponin increased	14.56	10.38	32	63143	8673	53277218
Glycosylated haemoglobin increased	14.29	10.38	38	63137	11617	53274274
Lactic acidosis	14.23	10.38	84	63091	37169	53248722
Psoriatic arthropathy	14.11	10.38	22	63153	48168	53237723
Ill-defined disorder	14.07	10.38	23	63152	49421	53236470
Platelet count decreased	14.03	10.38	73	63102	108026	53177865
Helicobacter gastritis	14.00	10.38	13	63162	1577	53284314
Muscle injury	13.97	10.38	9	63166	29757	53256134
Inappropriate schedule of product discontinuation	13.93	10.38	3	63172	6	53285885
C-reactive protein increased	13.93	10.38	38	63137	67848	53218043
Sedation	13.89	10.38	9	63166	29666	53256225
Gingival oedema	13.88	10.38	5	63170	94	53285797
Condition aggravated	13.88	10.38	258	62917	296876	52989015
Seizure	13.87	10.38	93	63082	129416	53156475
Blood cholesterol abnormal	13.84	10.38	16	63159	2506	53283385
Language disorder	13.78	10.38	14	63161	1897	53283994
Complex regional pain syndrome	13.74	10.38	15	63160	2208	53283683
Irritable bowel syndrome	13.67	10.38	19	63156	43613	53242278
Blood creatine phosphokinase MM increased	13.60	10.38	4	63171	38	53285853
Cataract	13.59	10.38	103	63072	49517	53236374
Hypertension	13.49	10.38	356	62819	225075	53060816
Pulmonary pain	13.36	10.38	15	63160	2277	53283614
Vitamin D deficiency	13.11	10.38	38	63137	12210	53273681
Intervertebral disc degeneration	13.09	10.38	42	63133	14256	53271635
Necrotising myositis	12.87	10.38	7	63168	361	53285530
Myoglobin blood increased	12.84	10.38	12	63163	1468	53284423
Hypocholesterolaemia	12.79	10.38	5	63170	119	53285772
Hypotrichosis	12.75	10.38	5	63170	120	53285771
Peripheral swelling	12.63	10.38	170	63005	205938	53079953
Malignant neoplasm progression	12.57	10.38	43	63132	71498	53214393
Muscle atrophy	12.49	10.38	25	63150	6349	53279542
Arteriosclerosis	12.43	10.38	33	63142	10078	53275813
Premature baby	12.38	10.38	4	63171	19797	53266094
Suicide attempt	12.36	10.38	32	63143	58136	53227755
Drug dependence	12.30	10.38	5	63170	21467	53264424
Non-high-density lipoprotein cholesterol increased	12.23	10.38	5	63170	134	53285757
Mucosal inflammation	12.08	10.38	20	63155	42764	53243127
Pancreatitis relapsing	12.07	10.38	9	63166	805	53285086
Neutrophil count decreased	12.05	10.38	25	63150	49073	53236818
Pulmonary haematoma	12.00	10.38	4	63171	59	53285832
Hypersensitivity pneumonitis	11.97	10.38	15	63160	2555	53283336
Pleural effusion	11.96	10.38	59	63116	88520	53197371
Septic shock	11.91	10.38	36	63139	62193	53223698
Impaired quality of life	11.91	10.38	21	63154	4850	53281041
Blood pressure increased	11.89	10.38	233	62942	140246	53145645
Ear haemorrhage	11.86	10.38	11	63164	1333	53284558
Pneumonia aspiration	11.71	10.38	14	63161	34287	53251604
Weight decreased	11.57	10.38	362	62813	234586	53051305
Abdominal pain upper	11.56	10.38	268	62907	166023	53119868
Discomfort	11.55	10.38	66	63109	95406	53190485
Nephropathy	11.53	10.38	22	63153	5395	53280496
Blister	11.49	10.38	51	63124	78702	53207189
Xanthelasma	11.37	10.38	4	63171	70	53285821
Acquired epidermolysis bullosa	11.32	10.38	4	63171	71	53285820
Autoimmune hepatitis	11.11	10.38	28	63147	8290	53277601
Nasal cyst	11.07	10.38	4	63171	76	53285815
Antiphospholipid syndrome	11.06	10.38	12	63163	1754	53284137
Purpura	10.98	10.38	33	63142	10820	53275071
Small intestinal haemorrhage	10.93	10.38	13	63162	2098	53283793
Renal tubular necrosis	10.88	10.38	34	63141	11385	53274506
Cerebellar syndrome	10.75	10.38	17	63158	3590	53282301
Peroneal nerve palsy	10.72	10.38	19	63156	4404	53281487
Rash	10.71	10.38	426	62749	445765	52840126
Low density lipoprotein abnormal	10.71	10.38	5	63170	186	53285705
White blood cell count decreased	10.69	10.38	95	63080	124380	53161511
Hyperleukocytosis	10.68	10.38	7	63168	509	53285382
Encephalopathy	10.59	10.38	17	63158	36791	53249100
Neoplasm progression	10.44	10.38	12	63163	29907	53255984

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
Myalgia	977.62	10.98	957	58666	80273	32373630
Rhabdomyolysis	509.79	10.98	622	59001	66643	32387260
Blood creatine phosphokinase increased	505.74	10.98	514	59109	44962	32408941
Myopathy	315.36	10.98	218	59405	11123	32442780
Low density lipoprotein increased	235.47	10.98	127	59496	4119	32449784
Myocardial infarction	132.68	10.98	518	59105	125158	32328745
Death	118.54	10.98	337	59286	382180	32071723
Coronary artery disease	117.90	10.98	273	59350	49433	32404470
Blood cholesterol increased	111.80	10.98	150	59473	17607	32436296
Angina pectoris	107.91	10.98	201	59422	31225	32422678
Muscular weakness	106.80	10.98	320	59303	67609	32386294
Drug abuse	98.05	10.98	15	59608	80228	32373675
Toxicity to various agents	95.05	10.98	112	59511	177929	32275974
Low density lipoprotein decreased	92.38	10.98	43	59580	1010	32452893
Muscle spasms	91.77	10.98	311	59312	70107	32383796
Immune-mediated myositis	89.80	10.98	49	59574	1626	32452277
Off label use	83.99	10.98	285	59338	306035	32147868
High density lipoprotein decreased	76.11	10.98	57	59566	3295	32450608
Febrile neutropenia	74.22	10.98	66	59557	119500	32334403
Venous pressure jugular increased	71.06	10.98	33	59590	771	32453132
Pancreatitis	67.92	10.98	188	59435	37963	32415940
Neutropenia	58.62	10.98	107	59516	142068	32311835
Type IIa hyperlipidaemia	57.86	10.98	20	59603	207	32453696
Myositis	57.53	10.98	86	59537	11149	32442754
Foetal exposure during pregnancy	57.19	10.98	5	59618	41296	32412607
Dizziness	56.05	10.98	609	59014	209009	32244894
Angina unstable	55.46	10.98	89	59534	12266	32441637
Blood triglycerides increased	54.59	10.98	97	59526	14522	32439381
Completed suicide	53.95	10.98	54	59569	92463	32361440
Drug interaction	51.19	10.98	618	59005	217567	32236336
Hepatic enzyme increased	48.57	10.98	164	59459	36873	32417030
Pneumonia	47.55	10.98	420	59203	354832	32099071
Necrotising myositis	47.37	10.98	22	59601	514	32453389
Pancreatitis acute	46.97	10.98	133	59490	27202	32426701
Liver function test abnormal	45.97	10.98	146	59477	31801	32422102
Suicide attempt	44.80	10.98	8	59615	38236	32415667
Asthenia	43.19	10.98	639	58984	235305	32218598
Blood cholesterol decreased	41.83	10.98	25	59598	989	32452914
Amyotrophic lateral sclerosis	38.06	10.98	24	59599	1046	32452857
Sepsis	38.02	10.98	156	59467	158678	32295225
Acute kidney injury	37.82	10.98	751	58872	292717	32161186
Malignant neoplasm progression	37.07	10.98	54	59569	78442	32375461
Pyrexia	36.96	10.98	392	59231	319576	32134327
Intentional overdose	36.92	10.98	15	59608	41586	32412317
Chest pain	36.56	10.98	368	59255	123769	32330134
Dyspnoea exertional	35.78	10.98	154	59469	38807	32415096
Acute coronary syndrome	35.72	10.98	79	59544	13862	32440041
Product use in unapproved indication	35.58	10.98	66	59557	87138	32366765
Chromaturia	34.81	10.98	80	59543	14398	32439505
Coronary artery occlusion	33.96	10.98	69	59554	11416	32442487
Pancytopenia	33.84	10.98	73	59550	91162	32362741
Erectile dysfunction	33.56	10.98	96	59527	19743	32434160
Septic shock	33.03	10.98	47	59576	68942	32384961
Pain in extremity	32.41	10.98	347	59276	118554	32335349
Erythromelalgia	31.85	10.98	9	59614	44	32453859
Cardiac failure congestive	30.74	10.98	263	59360	84589	32369314
Dissociation	30.69	10.98	22	59601	1188	32452715
Nonalcoholic fatty liver disease	30.23	10.98	14	59609	325	32453578
Cutaneous lupus erythematosus	30.10	10.98	18	59605	713	32453190
Muscle rupture	29.83	10.98	28	59595	2214	32451689
Muscle disorder	29.71	10.98	29	59594	2408	32451495
Drug dependence	29.57	10.98	4	59619	23480	32430423
Disease progression	29.39	10.98	73	59550	86789	32367114
Alanine aminotransferase increased	29.35	10.98	245	59378	78234	32375669
Hospitalisation	29.20	10.98	28	59595	48943	32404960
Glycogen storage disease type V	28.85	10.98	8	59615	36	32453867
Bone marrow failure	28.59	10.98	10	59613	30394	32423509
Ischaemic cardiomyopathy	28.40	10.98	46	59577	6388	32447515
Cytomegalovirus infection	28.40	10.98	6	59617	25458	32428445
White blood cell count decreased	28.31	10.98	80	59543	91118	32362785
Stent placement	27.80	10.98	38	59585	4537	32449366
Treatment failure	27.58	10.98	19	59604	39144	32414759
Overdose	27.31	10.98	76	59547	87001	32366902
Type V hyperlipidaemia	27.29	10.98	17	59606	725	32453178
Left ventricular dysfunction	27.20	10.98	57	59566	9638	32444265
Leukopenia	26.80	10.98	43	59580	60079	32393824
Aspartate aminotransferase increased	26.79	10.98	211	59412	66218	32387685
Mucosal inflammation	26.65	10.98	14	59609	33420	32420483
Myasthenia gravis	26.55	10.98	33	59590	3589	32450314
Ascites	26.36	10.98	21	59602	40170	32413733
Arthralgia	26.30	10.98	400	59223	148048	32305855
Muscle atrophy	26.17	10.98	47	59576	7093	32446810
Low density lipoprotein abnormal	26.17	10.98	12	59611	272	32453631
Oedema peripheral	26.16	10.98	322	59301	113769	32340134
Left atrial dilatation	26.11	10.98	24	59599	1848	32452055
Cardio-respiratory arrest	25.96	10.98	39	59584	55950	32397953
Plasma cell myeloma	25.88	10.98	41	59582	57573	32396330
Muscle injury	25.49	10.98	20	59603	1239	32452664
Haematocrit increased	25.36	10.98	23	59600	1740	32452163
Multiple organ dysfunction syndrome	24.99	10.98	57	59566	69797	32384106
Rheumatoid arthritis	24.82	10.98	27	59596	44517	32409386
Exercise lack of	24.33	10.98	9	59614	115	32453788
Phaeochromocytoma malignant	24.14	10.98	8	59615	72	32453831
Allergy to animal	23.92	10.98	11	59612	251	32453652
Infection	23.66	10.98	78	59545	84637	32369266
Dyslipidaemia	23.58	10.98	44	59579	6839	32447064
Exercise tolerance decreased	23.31	10.98	35	59588	4553	32449350
Pancreatic neoplasm	23.16	10.98	17	59606	953	32452950
Dyspnoea	22.99	10.98	845	58778	361200	32092703
Cardiac disorder	22.75	10.98	143	59480	41723	32412180
Toxic epidermal necrolysis	22.66	10.98	5	59618	20588	32433315
Food aversion	22.65	10.98	12	59611	375	32453528
Restrictive pulmonary disease	22.19	10.98	18	59605	1170	32452733
Platelet count decreased	21.87	10.98	122	59501	114469	32339434
Pemphigoid	21.83	10.98	48	59575	8388	32445515
Orthostatic hypotension	21.73	10.98	99	59524	25551	32428352
Hypercholesterolaemia	21.35	10.98	46	59577	7928	32445975
Total cholesterol/HDL ratio increased	21.28	10.98	9	59614	167	32453736
Mucosal dryness	20.89	10.98	17	59606	1110	32452793
Candida infection	20.83	10.98	3	59620	16800	32437103
Neutrophil count decreased	20.74	10.98	34	59589	47105	32406798
Acute myocardial infarction	20.52	10.98	172	59451	54977	32398926
Hypovolaemia	20.19	10.98	48	59575	8829	32445074
Faeces pale	20.16	10.98	19	59604	1510	32452393
Cardiac murmur	19.85	10.98	42	59581	7149	32446754
Tendon rupture	19.41	10.98	42	59581	7261	32446642
Myocardial ischaemia	19.32	10.98	74	59549	17685	32436218
Iron binding capacity total increased	19.30	10.98	6	59617	43	32453860
Hepatitis cholestatic	19.28	10.98	45	59578	8180	32445723
Respiratory arrest	19.09	10.98	15	59608	28893	32425010
Intentional product use issue	18.99	10.98	30	59593	42181	32411722
Self esteem decreased	18.71	10.98	12	59611	539	32453364
Laryngeal discomfort	18.60	10.98	8	59615	155	32453748
Arteriosclerosis	18.28	10.98	53	59570	10981	32442922
Ischaemic stroke	18.11	10.98	72	59551	17504	32436399
Spinal stenosis	18.02	10.98	31	59592	4523	32449380
Paraesthesia	17.93	10.98	176	59447	58768	32395135
Respiratory failure	17.89	10.98	119	59504	107063	32346840
Neck pain	17.88	10.98	86	59537	22701	32431202
Atrial fibrillation	17.86	10.98	307	59316	116397	32337506
Sedation	17.58	10.98	6	59617	18520	32435383
Thrombocytopenia	17.33	10.98	181	59442	148118	32305785
Aldolase increased	17.20	10.98	6	59617	64	32453839
Tumour lysis syndrome	17.13	10.98	3	59620	14544	32439359
Hyperlipidaemia	17.06	10.98	62	59561	14449	32439454
Coeliac disease	16.97	10.98	12	59611	634	32453269
Suspected suicide attempt	16.90	10.98	7	59616	123	32453780
Blood creatine phosphokinase decreased	16.66	10.98	11	59612	519	32453384
Lymphocyte count decreased	16.60	10.98	9	59614	21110	32432793
Back pain	16.58	10.98	291	59332	110762	32343141
ECG signs of myocardial ischaemia	16.41	10.98	8	59615	209	32453694
Haemoglobin increased	16.36	10.98	24	59599	3058	32450845
Coronary artery stenosis	16.18	10.98	47	59576	9746	32444157
Product use issue	15.85	10.98	47	59576	52730	32401173
Agitation	15.77	10.98	53	59570	57183	32396720
Delirium	15.70	10.98	36	59587	44010	32409893
Infusion related reaction	15.67	10.98	38	59585	45561	32408342
C-reactive protein increased	15.06	10.98	42	59581	48060	32405843
Pericardial haemorrhage	14.91	10.98	23	59600	3063	32450840
Muscle discomfort	14.89	10.98	5	59618	47	32453856
Polymyositis	14.87	10.98	16	59607	1490	32452413
Transaminases abnormal	14.87	10.98	8	59615	258	32453645
Fatigue	14.78	10.98	785	58838	349916	32103987
Flatulence	14.43	10.98	72	59551	19283	32434620
Stomatitis	14.24	10.98	33	59590	40196	32413707
Seizure	14.15	10.98	122	59501	103732	32350171
Drug withdrawal syndrome	14.00	10.98	10	59613	20221	32433682
Lipase increased	13.95	10.98	43	59580	9214	32444689
Pancreatic carcinoma	13.86	10.98	40	59583	8266	32445637
International normalised ratio abnormal	13.82	10.98	23	59600	3266	32450637
Peritonitis bacterial	13.82	10.98	3	59620	12493	32441410
Myoglobin urine	13.77	10.98	4	59619	22	32453881
Syncope	13.75	10.98	237	59386	89887	32364016
Thromboangiitis obliterans	13.47	10.98	4	59619	24	32453879
Dyspnoea at rest	13.46	10.98	23	59600	3336	32450567
Muscle strength abnormal	13.44	10.98	5	59618	65	32453838
Blood creatine phosphokinase	13.37	10.98	5	59618	66	32453837
Bronchopneumopathy	13.35	10.98	9	59614	440	32453463
Hypokalaemia	13.22	10.98	54	59569	55040	32398863
Gait disturbance	13.20	10.98	214	59409	80194	32373709
Pseudomonas infection	13.12	10.98	3	59620	12053	32441850
Autoimmune hepatitis	13.10	10.98	25	59598	3950	32449953
Inspiratory capacity abnormal	13.10	10.98	5	59618	70	32453833
Influenza like illness	13.10	10.98	90	59533	27050	32426853
Hepatitis E virus test positive	13.07	10.98	4	59619	27	32453876
Tumour invasion	13.06	10.98	8	59615	331	32453572
Status epilepticus	13.04	10.98	3	59620	12003	32441900
Peritonitis	13.04	10.98	13	59610	22317	32431586
Disseminated intravascular coagulation	12.96	10.98	14	59609	23162	32430741
Lower respiratory tract infection	12.95	10.98	21	59602	29222	32424681
Diaphragmatic disorder	12.82	10.98	13	59610	1130	32452773
Glycosylated haemoglobin increased	12.74	10.98	45	59578	10344	32443559
Ureteric cancer recurrent	12.71	10.98	4	59619	30	32453873
Haemorrhagic transformation stroke	12.67	10.98	14	59609	1344	32452559
Aortic embolus	12.63	10.98	3	59620	6	32453897
Pleural neoplasm	12.59	10.98	4	59619	31	32453872
Depressed level of consciousness	12.54	10.98	36	59587	40811	32413092
Neurotoxicity	12.48	10.98	6	59617	15064	32438839
Intentional product misuse	12.42	10.98	30	59593	36021	32417882
Electrocardiogram abnormal	12.39	10.98	37	59586	7793	32446110
Drug ineffective for unapproved indication	12.37	10.98	5	59618	13907	32439996
Aspergillus infection	12.36	10.98	3	59620	11571	32442332
Dyschromatopsia	12.34	10.98	8	59615	366	32453537
Autoimmune myositis	12.22	10.98	5	59618	85	32453818
Abulia	12.14	10.98	9	59614	512	32453391
Hypercapnic coma	12.09	10.98	6	59617	163	32453740
Neoplasm progression	12.00	10.98	11	59612	19647	32434256
Gamma-glutamyltransferase increased	11.98	10.98	97	59526	30685	32423218
Pulmonary embolism	11.97	10.98	97	59526	83562	32370341
Muscle fatigue	11.82	10.98	13	59610	1241	32452662
Chronic cutaneous lupus erythematosus	11.79	10.98	4	59619	39	32453864
Psychotic disorder	11.70	10.98	15	59608	23005	32430898
Vertigo	11.41	10.98	80	59543	24203	32429700
Respiratory depression	11.34	10.98	5	59618	13206	32440697
Blood glucose increased	11.22	10.98	175	59448	65066	32388837
Gastric dilatation	11.18	10.98	9	59614	579	32453324
Aggression	11.17	10.98	36	59587	39353	32414550
Coronary artery bypass	11.06	10.98	27	59596	5049	32448854
Erythrasma	11.04	10.98	4	59619	48	32453855

Pharmacologic Action:

Source	Code	Description
ATC	C10AX09	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN Other lipid modifying agents
ATC	C10BA02	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA05	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA06	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA10	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA11	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA12	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
FDA PE	N0000008553	Decreased Cholesterol Absorption
MeSH PA	D000924	Anticholesteremic Agents
MeSH PA	D000963	Antimetabolites
MeSH PA	D000960	Hypolipidemic Agents
MeSH PA	D057847	Lipid Regulating Agents
FDA EPC	N0000175911	Dietary Cholesterol Absorption Inhibitor
CHEBI has role	CHEBI:35221	antimetabolite
CHEBI has role	CHEBI:35679	hypolipidemic agent
CHEBI has role	CHEBI:35821	hypocholesteremic agent

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Hypercholesterolemia	indication	13644009
Hyperlipidemia	indication	55822004	DOID:1168
Familial hypercholesterolemia - homozygous	indication	238078005
Familial hypercholesterolemia - heterozygous	indication	238079002
Sitosterolemia	indication	238104009	DOID:0090019
Mixed hyperlipidemia	indication	267434003
Alopecia areata	off-label use	68225006	DOID:986
Alcoholism	contraindication	7200002
Acute nephropathy	contraindication	58574008
Disorder of muscle	contraindication	129565002	DOID:423
Liver function tests abnormal	contraindication	166603001
Acute pancreatitis	contraindication	197456007	DOID:2913
Hemorrhagic cerebral infarction	contraindication	230706003
Disease of liver	contraindication	235856003	DOID:409
Rhabdomyolysis	contraindication	240131006
Pregnancy, function	contraindication	289908002
Surgical procedure	contraindication	387713003
Breastfeeding (mother)	contraindication	413712001
SLCO1B1 Gene Variant for OATP1B1 Transporter Affecting Hepatic Clearance	contraindication
Myopathy related to SLCO1B1 Gene Variant	contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.48	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	10118881	Dec. 23, 2023	USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	10941095	Dec. 23, 2023	USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	8497301	Dec. 23, 2023	USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	9000041	Dec. 23, 2023	USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	9624152	Dec. 23, 2023	USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY FOR INHIBITING CHOLESTEROL SYNTHESIS TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
10MG	ZETIA	ORGANON	N021445	Oct. 25, 2002	RX	TABLET	ORAL	7612058	Oct. 30, 2025	REDUCTION OF ELEVATED PLASMA STEROL AND/OR STANOL LEVELS IN A MAMMAL
10MG	ZETIA	ORGANON	N021445	Oct. 25, 2002	RX	TABLET	ORAL	7612058	Oct. 30, 2025	TO REDUCE ELEVATED TOTAL-C, LDL-C, APO B AND NON-HDL-C IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE ALONE OR IN COMBINATION WITH A STATIN OR WITH FENOFIBRATE
10MG;EQ 10MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	RX	TABLET	ORAL	10376470	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 10MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	RX	TABLET	ORAL	9763885	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 20MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	RX	TABLET	ORAL	10376470	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 20MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	RX	TABLET	ORAL	9763885	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 40MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	RX	TABLET	ORAL	10376470	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 40MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	RX	TABLET	ORAL	9763885	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 5MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	RX	TABLET	ORAL	10376470	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 5MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	RX	TABLET	ORAL	9763885	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	10912751	March 14, 2036	A METHOD OF TREATING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE BY DECREASING THE LEVEL OF LDL-C USING A FIXED DOSE COMBINATION OF 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	Feb. 26, 2023	NEW PRODUCT
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	Feb. 21, 2025	NEW CHEMICAL ENTITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Niemann-Pick C1-like protein 1	Membrane other	Q9UHC9	NPCL1_HUMAN	ANTAGONIST	Kd	6.66		IUPHAR	CHEMBL
Niemann-Pick C1-like protein 1	Unclassified		NPCL1_RAT		Ki	6.70		CHEMBL

External reference:

ID	Source
4021366	VUID
N0000148785	NUI
D01966	KEGG_DRUG
4021366	VANDF
C1142985	UMLSCUI
CHEBI:49040	CHEBI
H56	PDB_CHEM_ID
CHEMBL1138	ChEMBL_ID
D000069438	MESH_DESCRIPTOR_UI
DB00973	DRUGBANK_ID
150311	PUBCHEM_CID
6816	IUPHAR_LIGAND_ID
8010	INN_ID
EOR26LQQ24	UNII
341248	RXNORM
17026	MMSL
229065	MMSL
45364	MMSL
d04824	MMSL
009817	NDDF
408041006	SNOMEDCT_US
409149001	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3713	TABLET	10 mg	ORAL	ANDA	26 sections
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8300	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5690	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6664	TABLET	10 mg	ORAL	ANDA	28 sections
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7103	TABLET	10 mg	ORAL	ANDA	26 sections
ezetimibe and simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	16714-778	TABLET	10 mg	ORAL	ANDA	28 sections
ezetimibe and simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	16714-779	TABLET	10 mg	ORAL	ANDA	28 sections
ezetimibe and simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	16714-780	TABLET	10 mg	ORAL	ANDA	28 sections
ezetimibe and simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	16714-781	TABLET	10 mg	ORAL	ANDA	28 sections
Ezetimibe	Human Prescription Drug Label	1	16714-813	TABLET	10 mg	ORAL	ANDA	28 sections
EZETIMIBE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-433	TABLET	10 mg	ORAL	ANDA	29 sections
VYTORIN	HUMAN PRESCRIPTION DRUG LABEL	2	21695-325	TABLET	10 mg	ORAL	NDA	28 sections
VYTORIN	HUMAN PRESCRIPTION DRUG LABEL	2	21695-339	TABLET	10 mg	ORAL	NDA	28 sections
Zetia	HUMAN PRESCRIPTION DRUG LABEL	1	21695-778	TABLET	10 mg	ORAL	NDA	29 sections
VYTORIN	HUMAN PRESCRIPTION DRUG LABEL	2	21695-827	TABLET	10 mg	ORAL	NDA	28 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	43598-742	TABLET	10 mg	ORAL	ANDA	28 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	43598-743	TABLET	10 mg	ORAL	ANDA	28 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	43598-744	TABLET	10 mg	ORAL	ANDA	28 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	43598-745	TABLET	10 mg	ORAL	ANDA	28 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	45963-565	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	45963-566	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	45963-567	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	45963-568	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3087	TABLET	10 mg	ORAL	ANDA	26 sections
Ezetimibe	Human Prescription Drug Label	1	50090-3657	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	50090-3984	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe and Simvastatin	Human Prescription Drug Label	2	50090-4772	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	50228-379	TABLET	10 mg	ORAL	ANDA	29 sections
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	50268-298	TABLET	10 mg	ORAL	ANDA	26 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	51407-190	TABLET	10 mg	ORAL	ANDA	28 sections