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

Stem definition	Drug id	CAS RN
diazepam derivatives	2585	846-50-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: temazepam (RS)-Temazepam levanxene levanxol	A benzodiazepine that acts as a GAMMA-AMINOBUTYRIC ACID modulator and anti-anxiety agent. Molecular weight: 300.74 Formula: C16H13ClN2O2 CLOGP: 2.34 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 52.90 ALOGS: -3.75 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

temazepam
(RS)-Temazepam
levanxene
levanxol

A benzodiazepine that acts as a GAMMA-AMINOBUTYRIC ACID modulator and anti-anxiety agent.

Molecular weight: 300.74
Formula: C16H13ClN2O2
CLOGP: 2.34
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 52.90
ALOGS: -3.75
ROTB: 1

Status: OFP

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

Drug dosage:

Dose	Unit	Route
20	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.60 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.83 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	91 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Feb. 27, 1981	FDA	MALLINCKRODT INC

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
Completed suicide	388.87	10.39	548	47406	131341	50425829
Toxicity to various agents	358.70	10.39	686	47268	211813	50345357
Temperature regulation disorder	235.55	10.39	103	47851	4124	50553046
Coeliac disease	188.74	10.39	112	47842	8573	50548597
Overdose	176.48	10.39	329	47625	99398	50457772
Food allergy	174.39	10.39	104	47850	8033	50549137
Immunodeficiency	124.36	10.39	107	47847	14721	50542449
Bursitis	105.17	10.39	117	47837	22018	50535152
Hyperhidrosis	102.25	10.39	247	47707	89179	50467991
Drug ineffective	99.69	10.39	420	47534	818913	49738257
Maternal exposure during pregnancy	99.64	10.39	16	47938	159762	50397408
Respiratory arrest	99.18	10.39	132	47822	29877	50527293
Synovitis	96.73	10.39	5	47949	123860	50433310
Drug intolerance	86.70	10.39	50	47904	219054	50338116
Hand deformity	81.67	10.39	3	47951	100196	50456974
Myocardial depression	81.30	10.39	26	47928	424	50556746
Rash erythematous	81.26	10.39	130	47824	34722	50522448
Off label use	79.56	10.39	211	47743	474215	50082955
Fluid retention	76.00	10.39	156	47798	50493	50506677
Decorticate posture	69.43	10.39	21	47933	282	50556888
Arthropathy	66.89	10.39	33	47921	157873	50399297
Poisoning	63.03	10.39	68	47886	12361	50544809
Cardiac arrest	62.67	10.39	198	47756	83453	50473717
Glossodynia	60.94	10.39	17	47937	115552	50441618
Constipation	59.52	10.39	339	47615	185369	50371801
Wound	58.77	10.39	14	47940	105780	50451390
Systemic lupus erythematosus	58.63	10.39	30	47924	140592	50416578
Accidental overdose	58.60	10.39	82	47872	19451	50537719
Infusion related reaction	57.28	10.39	46	47908	169511	50387659
Asthma	55.02	10.39	198	47756	89139	50468031
Abdominal discomfort	55.01	10.39	84	47870	231557	50325613
Swelling	53.55	10.39	67	47887	200805	50356365
Drug abuse	52.70	10.39	150	47804	59696	50497474
Libido increased	49.53	10.39	24	47930	1219	50555951
Pericarditis	48.76	10.39	8	47946	78681	50478489
Exposure during pregnancy	47.28	10.39	28	47926	120987	50436183
Hostility	46.78	10.39	26	47928	1756	50555414
Back pain	46.46	10.39	362	47592	219668	50337502
Substance abuse	45.65	10.39	35	47919	4089	50553081
Discomfort	45.35	10.39	23	47931	108357	50448813
Rash	44.81	10.39	238	47716	437233	50119937
Respiratory depression	44.63	10.39	56	47898	11954	50545216
Cardio-respiratory arrest	44.49	10.39	132	47822	53760	50503410
Treatment failure	44.43	10.39	39	47915	137598	50419572
Upper respiratory tract infection	42.23	10.39	148	47806	65750	50491420
Arthralgia	40.43	10.39	247	47707	438455	50118715
Victim of sexual abuse	40.15	10.39	16	47938	505	50556665
Venous pressure jugular increased	39.34	10.39	16	47938	533	50556637
Coma scale abnormal	39.13	10.39	34	47920	4737	50552433
Sternal fracture	38.81	10.39	24	47930	1978	50555192
Post-traumatic neck syndrome	37.29	10.39	23	47931	1887	50555283
Soft tissue injury	37.19	10.39	21	47933	1463	50555707
Anxiety	35.71	10.39	289	47665	177317	50379853
Insomnia	35.41	10.39	285	47669	174580	50382590
Joint swelling	35.26	10.39	117	47837	245169	50312001
Peripheral swelling	34.84	10.39	91	47863	205845	50351325
Impaired reasoning	34.07	10.39	9	47945	71	50557099
Hypothermia	33.91	10.39	49	47905	11967	50545203
Transplant dysfunction	31.77	10.39	30	47924	4654	50552516
Infected dermal cyst	31.74	10.39	13	47941	441	50556729
Amblyopia	31.72	10.39	11	47943	233	50556937
Therapeutic product effect decreased	29.77	10.39	52	47902	135998	50421172
Alopecia	29.30	10.39	126	47828	244921	50312249
Kyphosis	28.80	10.39	21	47933	2274	50554896
Judgement impaired	28.66	10.39	13	47941	568	50556602
Suicidal ideation	28.52	10.39	116	47838	55269	50501901
Therapeutic product effect incomplete	28.25	10.39	27	47927	91488	50465682
Personality disorder	28.01	10.39	27	47927	4297	50552873
Toxicologic test abnormal	27.79	10.39	13	47941	610	50556560
Intentional overdose	27.64	10.39	125	47829	62379	50494791
Drug withdrawal syndrome	27.27	10.39	68	47886	25013	50532157
Apnoea	26.71	10.39	33	47921	6933	50550237
Folliculitis	26.63	10.39	3	47951	39222	50517948
Rectal prolapse	26.59	10.39	18	47936	1731	50555439
Thiopurine methyltransferase decreased	25.76	10.39	10	47944	294	50556876
Duodenal ulcer perforation	25.39	10.39	6	47948	45605	50511565
Somnambulism	25.07	10.39	27	47927	4897	50552273
Band neutrophil percentage increased	25.06	10.39	9	47945	212	50556958
Miosis	24.37	10.39	30	47924	6280	50550890
Contraindicated product administered	24.29	10.39	67	47887	148891	50408279
Tremor	24.18	10.39	189	47765	114714	50442456
Somnolence	23.85	10.39	238	47716	154747	50402423
Depression	23.54	10.39	250	47704	165173	50391997
Ventricular hypokinesia	22.36	10.39	23	47931	3957	50553213
Nightmare	22.31	10.39	48	47906	16038	50541132
Panic attack	21.62	10.39	53	47901	19289	50537881
Myelocyte percentage increased	21.60	10.39	8	47946	206	50556964
Oesophagitis ulcerative	21.40	10.39	10	47944	468	50556702
Nasopharyngitis	21.37	10.39	102	47852	192825	50364345
Infection	21.23	10.39	88	47866	172866	50384304
Mental disorder	21.21	10.39	57	47897	21934	50535236
Poor quality sleep	21.20	10.39	48	47906	16598	50540572
Band neutrophil count increased	21.02	10.39	9	47945	342	50556828
Neutropenia	20.95	10.39	71	47883	147894	50409276
Urine oxalate increased	20.81	10.39	8	47946	229	50556941
Withdrawal syndrome	20.52	10.39	49	47905	17541	50539629
Homicide	20.51	10.39	9	47945	363	50556807
Muscle injury	20.42	10.39	5	47949	37106	50520064
Bundle branch block left	19.96	10.39	27	47927	6203	50550967
Rectal polyp	19.85	10.39	12	47942	949	50556221
Gastrointestinal disorder	19.85	10.39	37	47917	94419	50462751
Accidental death	19.74	10.39	15	47939	1729	50555441
Retinal depigmentation	19.46	10.39	8	47946	274	50556896
Blister	19.27	10.39	32	47922	85386	50471784
Analgesic drug level above therapeutic	19.21	10.39	7	47947	172	50556998
Poisoning deliberate	19.10	10.39	30	47924	7882	50549288
Unresponsive to stimuli	18.96	10.39	68	47886	30541	50526629
Musculoskeletal stiffness	18.63	10.39	61	47893	128420	50428750
Interstitial lung disease	18.47	10.39	14	47940	53162	50504008
Suspected product quality issue	18.29	10.39	7	47947	198	50556972
Duodenal ulcer	18.21	10.39	27	47927	6748	50550422
Intentional product use issue	18.12	10.39	28	47926	76890	50480280
Dystrophic calcification	18.01	10.39	6	47948	112	50557058
Myelocyte count increased	17.73	10.39	8	47946	345	50556825
Stomatitis	17.72	10.39	44	47910	101300	50455870
Hypovolaemia	17.68	10.39	32	47922	9433	50547737
Ovarian cyst	17.43	10.39	40	47914	13956	50543214
Depressed mood	17.31	10.39	71	47883	33952	50523218
Pulmonary congestion	17.27	10.39	42	47912	15205	50541965
Arteriosclerosis coronary artery	17.13	10.39	28	47926	7608	50549562
Atrioventricular block first degree	17.08	10.39	25	47929	6176	50550994
Dehydration	17.06	10.39	220	47734	152229	50404941
Abnormal behaviour	17.03	10.39	49	47905	19609	50537561
Injection site erythema	16.97	10.39	28	47926	74908	50482262
Ill-defined disorder	15.87	10.39	17	47937	54637	50502533
C-reactive protein increased	15.85	10.39	24	47930	66450	50490720
Urticaria	15.84	10.39	66	47888	129495	50427675
Irritability	15.81	10.39	61	47893	28365	50528805
Rib fracture	15.78	10.39	47	47907	19174	50537996
Homicidal ideation	15.75	10.39	13	47941	1689	50555481
Psoriatic arthropathy	15.56	10.39	13	47941	47019	50510151
Mass	15.42	10.39	35	47919	12122	50545048
Middle insomnia	15.39	10.39	31	47923	9890	50547280
Suspected counterfeit product	15.32	10.39	7	47947	311	50556859
Hepatocellular injury	15.28	10.39	3	47951	25944	50531226
Cardiac failure congestive	15.18	10.39	134	47820	84248	50472922
Helicobacter infection	14.95	10.39	15	47939	49687	50507483
Upper respiratory tract congestion	14.93	10.39	13	47941	1816	50555354
Transplant rejection	14.88	10.39	30	47924	9579	50547591
General physical health deterioration	14.79	10.39	77	47877	142357	50414813
Abortion spontaneous	14.51	10.39	11	47943	41761	50515409
Sensitisation	14.46	10.39	12	47942	1570	50555600
Bruxism	14.32	10.39	16	47938	3024	50554146
Calculus urethral	14.28	10.39	3	47951	7	50557163
Memory impairment	14.26	10.39	126	47828	79234	50477936
Monocyte percentage increased	14.15	10.39	10	47944	1031	50556139
Mood swings	14.04	10.39	40	47914	15914	50541256
Loss of consciousness	14.04	10.39	156	47798	104197	50452973
Postmortem blood drug level increased	13.95	10.39	8	47946	574	50556596
Dysgeusia	13.74	10.39	73	47881	38843	50518327
Febrile neutropenia	13.73	10.39	47	47907	97620	50459550
Arteriosclerosis	13.65	10.39	28	47926	9049	50548121
Amnesia	13.40	10.39	77	47877	42183	50514987
Premature delivery	13.39	10.39	3	47951	23660	50533510
Stress	13.31	10.39	92	47862	53701	50503469
Change of bowel habit	13.21	10.39	12	47942	1772	50555398
Bacterial test	13.20	10.39	10	47944	1147	50556023
Sinusitis	13.18	10.39	101	47853	170457	50386713
Respiratory alkalosis	13.16	10.39	14	47940	2505	50554665
Akathisia	13.11	10.39	26	47928	8203	50548967
Knee arthroplasty	13.02	10.39	9	47945	35837	50521333
Cardioactive drug level above therapeutic	12.98	10.39	5	47949	144	50557026
Specific gravity urine decreased	12.72	10.39	8	47946	679	50556491
Peptic ulcer perforation	12.66	10.39	5	47949	154	50557016
Road traffic accident	12.53	10.39	51	47903	24301	50532869
Liver injury	12.43	10.39	4	47950	24802	50532368
Chronic obstructive pulmonary disease	12.42	10.39	90	47864	53345	50503825
Microscopic polyangiitis	12.37	10.39	5	47949	164	50557006
Leukopenia	12.05	10.39	29	47925	67499	50489671
Hip arthroplasty	11.93	10.39	7	47947	30422	50526748
Hyperthermia	11.88	10.39	24	47930	7672	50549498
Irritable bowel syndrome	11.85	10.39	19	47935	51422	50505748
Blood glucose fluctuation	11.83	10.39	17	47937	4129	50553041
Death	11.76	10.39	397	47557	324982	50232188
Clonus	11.74	10.39	17	47937	4158	50553012
Acquired immunodeficiency syndrome	11.66	10.39	4	47950	82	50557088
Diabetes mellitus	11.63	10.39	83	47871	48950	50508220
Pruritus	11.57	10.39	194	47760	283374	50273796
Septic shock	11.48	10.39	23	47931	57152	50500018
Mental impairment	11.39	10.39	31	47923	12013	50545157
Subendocardial ischaemia	11.35	10.39	4	47950	89	50557081
Post-traumatic pain	11.30	10.39	6	47948	370	50556800
Upper-airway cough syndrome	11.27	10.39	25	47929	8525	50548645
Migraine	11.27	10.39	115	47839	75165	50482005
Antidepressant drug level above therapeutic	11.20	10.39	6	47948	377	50556793
Stoma site discomfort	11.11	10.39	4	47950	95	50557075
Dilatation atrial	11.00	10.39	11	47943	1830	50555340
Acne	10.86	10.39	42	47912	19553	50537617
Concussion	10.85	10.39	23	47931	7605	50549565
Respiratory rate decreased	10.77	10.39	14	47940	3094	50554076
Herpes zoster	10.68	10.39	33	47921	70753	50486417
Postmortem blood drug level	10.52	10.39	4	47950	111	50557059
Klebsiella test positive	10.52	10.39	8	47946	923	50556247
Intestinal haemorrhage	10.52	10.39	14	47940	3166	50554004
Blood albumin decreased	10.52	10.39	32	47922	13204	50543966
Drug reaction with eosinophilia and systemic symptoms	10.51	10.39	7	47947	28417	50528753

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
Toxicity to various agents	582.22	11.13	772	27725	172889	29373141
Completed suicide	335.12	11.13	423	28074	89823	29456207
Drug abuse	150.27	11.13	273	28224	79610	29466420
Aggression	101.63	11.13	147	28350	35394	29510636
Dysarthria	97.49	11.13	134	28363	30777	29515253
Overdose	85.34	11.13	217	28280	79602	29466428
Intrusive thoughts	81.65	11.13	23	28474	232	29545798
Off label use	72.87	11.13	111	28386	300689	29245341
Substance abuse	70.84	11.13	56	28441	6731	29539299
Logorrhoea	69.58	11.13	37	28460	2251	29543779
Poisoning	68.81	11.13	65	28432	9928	29536102
Suicidal ideation	56.90	11.13	112	28385	34604	29511426
Tachyphrenia	53.63	11.13	25	28472	1144	29544886
Dystonic tremor	50.74	11.13	15	28482	182	29545848
Homicidal ideation	50.35	11.13	31	28466	2493	29543537
Drug dependence	50.32	11.13	80	28417	20901	29525129
Accidental overdose	49.14	11.13	72	28425	17521	29528509
Bradyphrenia	48.84	11.13	37	28460	4177	29541853
Psychotic disorder	47.98	11.13	77	28420	20277	29525753
Suicide attempt	47.61	11.13	103	28394	34007	29512023
Bradykinesia	46.11	11.13	33	28464	3414	29542616
Abnormal behaviour	43.32	11.13	79	28418	23048	29522982
Sedation	39.87	11.13	65	28432	17340	29528690
Pulmonary congestion	39.31	11.13	54	28443	12382	29533648
Restlessness	35.74	11.13	71	28426	22074	29523956
Coordination abnormal	35.68	11.13	39	28458	7075	29538955
Injury	35.59	11.13	65	28432	18981	29527049
Anxiety	32.94	11.13	166	28331	85199	29460831
Insomnia	31.75	11.13	169	28328	88592	29457438
Anger	31.03	11.13	45	28452	10845	29535185
Loss of libido	30.75	11.13	22	28475	2274	29543756
Depressed level of consciousness	28.21	11.13	89	28408	36853	29509177
Hallucination, auditory	27.86	11.13	40	28457	9553	29536477
Psychotic behaviour	27.37	11.13	13	28484	621	29545409
Restless legs syndrome	26.21	11.13	33	28464	6951	29539079
Drug withdrawal syndrome	25.88	11.13	55	28442	17929	29528101
Crystalluria	25.86	11.13	11	28486	404	29545626
Paranoia	25.54	11.13	39	28458	9838	29536192
Irritability	25.49	11.13	62	28435	22090	29523940
Drug interaction	25.32	11.13	296	28201	197089	29348941
Mood swings	25.23	11.13	33	28464	7218	29538812
Respiratory depression	25.07	11.13	46	28451	13477	29532553
Febrile neutropenia	24.65	11.13	44	28453	112196	29433834
Drug ineffective	24.52	11.13	228	28269	362942	29183088
Emotional distress	22.96	11.13	45	28452	13850	29532180
Mesothelioma	22.64	11.13	10	28487	403	29545627
Behaviour disorder	22.03	11.13	22	28475	3594	29542436
Congestive hepatopathy	21.99	11.13	16	28481	1698	29544332
Interstitial lung disease	20.99	11.13	15	28482	57703	29488327
Drug level below therapeutic	20.70	11.13	23	28474	4248	29541782
Mental disorder	20.37	11.13	41	28456	12864	29533166
Depression	20.26	11.13	146	28351	85001	29461029
Homicide	20.06	11.13	12	28485	916	29545114
Osmolar gap abnormal	20.03	11.13	5	28492	30	29546000
Agitation	19.93	11.13	100	28397	51204	29494826
Miosis	19.83	11.13	31	28466	7978	29538052
Accidental poisoning	19.77	11.13	10	28487	548	29545482
Emotional disorder	19.63	11.13	24	28473	4907	29541123
Drug abuser	19.22	11.13	21	28476	3806	29542224
Needle fatigue	19.09	11.13	10	28487	590	29545440
Somnambulism	18.88	11.13	18	28479	2780	29543250
Antasthmatic drug level	18.78	11.13	5	28492	40	29545990
Analgesic drug level	18.78	11.13	5	28492	40	29545990
General physical health deterioration	18.63	11.13	45	28452	102812	29443218
Obsessive-compulsive disorder	17.78	11.13	22	28475	4554	29541476
Gait spastic	17.77	11.13	10	28487	680	29545350
Cardiac asthma	17.63	11.13	7	28490	215	29545815
Drug screen positive	17.62	11.13	20	28477	3781	29542249
Personality change	17.54	11.13	22	28475	4616	29541414
Somnolence	17.36	11.13	152	28345	93803	29452227
Relapsing-remitting multiple sclerosis	17.22	11.13	10	28487	722	29545308
Treatment failure	17.22	11.13	7	28490	36932	29509098
Patient uncooperative	17.12	11.13	8	28489	368	29545662
Memory impairment	17.03	11.13	75	28422	36395	29509635
Conduction disorder	16.71	11.13	14	28483	1826	29544204
Depersonalisation/derealisation disorder	16.56	11.13	9	28488	572	29545458
Blood disorder	16.41	11.13	17	28480	2900	29543130
Feelings of worthlessness	16.38	11.13	7	28490	260	29545770
Contraindication to medical treatment	15.76	11.13	8	28489	442	29545588
Sexually transmitted disease	15.75	11.13	4	28493	26	29546004
Hypertonic bladder	15.16	11.13	12	28485	1444	29544586
Lethargy	15.12	11.13	74	28423	37506	29508524
Accidental death	15.00	11.13	14	28483	2104	29543926
Confusional state	14.72	11.13	188	28309	127689	29418341
Hepatic function abnormal	14.54	11.13	10	28487	39249	29506781
Nervousness	14.48	11.13	33	28464	11273	29534757
Pulmonary oedema	14.33	11.13	80	28417	42655	29503375
Joint swelling	14.32	11.13	16	28481	49614	29496416
Gait disturbance	14.25	11.13	120	28377	73229	29472801
Victim of crime	14.15	11.13	7	28490	366	29545664
Thinking abnormal	14.00	11.13	21	28476	5215	29540815
Tangentiality	13.91	11.13	5	28492	116	29545914
Vestibular disorder	13.89	11.13	10	28487	1044	29544986
Sexually inappropriate behaviour	13.65	11.13	7	28490	395	29545635
Exposure via ingestion	13.65	11.13	13	28484	2005	29544025
Renal impairment	13.63	11.13	37	28460	81296	29464734
Fear	13.59	11.13	29	28468	9475	29536555
Unresponsive to stimuli	13.55	11.13	54	28443	25072	29520958
Product use in unapproved indication	13.48	11.13	41	28456	86834	29459196
Foetal exposure during pregnancy	13.40	11.13	8	28489	33859	29512171
Amnesia	13.30	11.13	50	28447	22593	29523437
Cerebral arteriovenous malformation haemorrhagic	13.14	11.13	4	28493	54	29545976
Withdrawal syndrome	12.89	11.13	31	28466	10961	29535069
Pyrexia	12.67	11.13	198	28299	287424	29258606
Acute kidney injury	12.58	11.13	180	28317	265087	29280943
Breast cancer male	12.54	11.13	6	28491	291	29545739
Dysprosody	12.48	11.13	3	28494	15	29546015
Physical disability	12.34	11.13	10	28487	1244	29544786
Alcohol poisoning	12.24	11.13	15	28482	3074	29542956
Cardiomegaly	12.22	11.13	35	28462	13741	29532289
Borderline personality disorder	11.77	11.13	6	28491	334	29545696
Cytomegalovirus infection	11.49	11.13	4	28493	23211	29522819
Gun shot wound	11.42	11.13	9	28488	1076	29544954
Ventricular hypertrophy	11.25	11.13	17	28480	4247	29541783
Neck injury	11.19	11.13	9	28488	1108	29544922

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
Toxicity to various agents	850.16	10.17	1364	60712	362149	64074507
Completed suicide	742.73	10.17	993	61083	223421	64213235
Temperature regulation disorder	240.86	10.17	105	61971	4106	64432550
Overdose	227.20	10.17	485	61591	159081	64277575
Drug abuse	204.34	10.17	416	61660	131958	64304698
Coeliac disease	203.64	10.17	112	61964	7300	64429356
Food allergy	171.10	10.17	102	61974	7749	64428907
Poisoning	140.73	10.17	137	61939	21742	64414914
Off label use	122.81	10.17	267	61809	632539	63804117
Immunodeficiency	115.18	10.17	107	61969	16017	64420639
Substance abuse	113.14	10.17	84	61992	9208	64427448
Bursitis	108.27	10.17	118	61958	21367	64415289
Accidental overdose	108.18	10.17	147	61929	33410	64403246
Respiratory arrest	95.64	10.17	178	61898	52807	64383849
Aggression	86.82	10.17	158	61918	46074	64390582
Drug ineffective	86.22	10.17	467	61609	839780	63596876
Myocardial depression	82.07	10.17	27	62049	476	64436180
Synovitis	75.69	10.17	5	62071	99085	64337571
Dysarthria	73.62	10.17	171	61905	59235	64377421
Death	73.49	10.17	748	61328	481957	63954699
Respiratory depression	72.99	10.17	101	61975	23342	64413314
Decorticate posture	68.17	10.17	21	62055	296	64436360
Fluid retention	67.84	10.17	166	61910	59440	64377216
Intrusive thoughts	65.15	10.17	21	62055	346	64436310
Maternal exposure during pregnancy	64.78	10.17	8	62068	95876	64340780
Drug intolerance	62.99	10.17	53	62023	187939	64248717
Hyperhidrosis	62.48	10.17	262	61814	124658	64311998
Logorrhoea	61.67	10.17	42	62034	4017	64432639
Abnormal behaviour	58.23	10.17	111	61965	33511	64403145
Suicidal ideation	58.15	10.17	168	61908	66374	64370282
Rash erythematous	58.08	10.17	138	61938	48495	64388161
Homicidal ideation	57.48	10.17	37	62039	3220	64433436
Pulmonary congestion	57.25	10.17	91	61985	23789	64412867
Cardiac arrest	53.65	10.17	291	61785	153773	64282883
Cardio-respiratory arrest	52.85	10.17	211	61865	98182	64338474
Dystonic tremor	50.76	10.17	15	62061	182	64436474
Hand deformity	48.43	10.17	3	62073	62768	64373888
Drug dependence	48.15	10.17	102	61974	33210	64403446
Tachyphrenia	47.85	10.17	27	62049	1849	64434807
Asthma	45.49	10.17	197	61879	95028	64341628
Insomnia	45.41	10.17	336	61740	197500	64239156
Arthropathy	44.46	10.17	31	62045	120936	64315720
Infusion related reaction	44.19	10.17	56	62020	164411	64272245
Miosis	44.09	10.17	59	62017	13207	64423449
Suicide attempt	43.67	10.17	159	61917	70848	64365808
Libido increased	43.60	10.17	25	62051	1765	64434891
Irritability	43.58	10.17	104	61972	36642	64400014
Coma scale abnormal	43.23	10.17	45	62031	7729	64428927
Arthralgia	42.33	10.17	251	61825	442009	63994647
Homicide	41.90	10.17	21	62055	1130	64435526
Interstitial lung disease	40.14	10.17	22	62054	97710	64338946
Victim of sexual abuse	40.07	10.17	15	62061	392	64436264
Discomfort	39.86	10.17	14	62062	80864	64355792
Hostility	38.77	10.17	25	62051	2182	64434474
Sternal fracture	38.36	10.17	25	62051	2222	64434434
Soft tissue injury	38.32	10.17	22	62054	1557	64435099
Mental disorder	38.25	10.17	81	61995	26364	64410292
Peripheral swelling	38.15	10.17	91	61985	209062	64227594
Psychotic disorder	37.96	10.17	95	61981	34483	64402173
Anxiety	37.68	10.17	328	61748	202321	64234335
Mood swings	37.06	10.17	63	62013	17405	64419251
Post-traumatic neck syndrome	37.04	10.17	23	62053	1879	64434777
Bradykinesia	36.53	10.17	38	62038	6522	64430134
Intentional overdose	36.23	10.17	177	61899	89767	64346889
General physical health deterioration	34.90	10.17	92	61984	204333	64232323
Depression	34.77	10.17	298	61778	182993	64253663
Back pain	33.87	10.17	379	61697	249792	64186864
Rash	33.68	10.17	281	61795	458268	63978388
Restlessness	33.36	10.17	99	61977	39686	64396970
Bradyphrenia	33.06	10.17	43	62033	9363	64427293
Somnolence	32.99	10.17	320	61756	203325	64233331
Memory impairment	32.66	10.17	166	61910	85516	64351140
Drug withdrawal syndrome	32.30	10.17	84	61992	31207	64405449
Swelling	32.26	10.17	66	62010	160152	64276504
Kyphosis	32.24	10.17	23	62053	2370	64434286
Sedation	31.80	10.17	100	61976	41362	64395294
Impaired reasoning	31.68	10.17	9	62067	94	64436562
Febrile neutropenia	31.62	10.17	85	61991	187572	64249084
Drug abuser	31.19	10.17	33	62043	5775	64430881
Depressed level of consciousness	30.50	10.17	157	61919	81279	64355377
Coordination abnormal	30.47	10.17	53	62023	14911	64421745
Treatment failure	30.11	10.17	41	62035	116775	64319881
Loss of libido	29.87	10.17	22	62054	2382	64434274
Upper respiratory tract infection	29.86	10.17	144	61932	72641	64364015
Exposure during pregnancy	29.76	10.17	19	62057	77656	64359000
Accidental death	29.10	10.17	26	62050	3699	64432957
Constipation	29.05	10.17	343	61733	228994	64207662
Judgement impaired	28.88	10.17	16	62060	1057	64435599
Amblyopia	28.59	10.17	10	62066	214	64436442
Acute kidney injury	27.93	10.17	287	61789	448953	63987703
Poisoning deliberate	27.84	10.17	48	62028	13410	64423246
Unresponsive to stimuli	27.80	10.17	109	61967	50284	64386372
Hepatocellular injury	27.73	10.17	5	62071	45230	64391426
Joint swelling	27.67	10.17	110	61966	215272	64221384
Personality disorder	27.52	10.17	28	62048	4683	64431973
Pericarditis	27.27	10.17	13	62063	62503	64374153
Toxicologic test abnormal	26.91	10.17	16	62060	1209	64435447
Rectal prolapse	26.56	10.17	18	62058	1708	64434948
Venous pressure jugular increased	26.46	10.17	16	62060	1247	64435409
Drug screen positive	26.34	10.17	30	62046	5699	64430957
Transplant dysfunction	25.68	10.17	32	62044	6676	64429980
Abdominal discomfort	25.44	10.17	90	61986	182232	64254424
Cytomegalovirus infection	25.37	10.17	3	62073	37196	64399460
Poor quality sleep	25.07	10.17	56	62020	18895	64417761
Thiopurine methyltransferase decreased	25.02	10.17	10	62066	313	64436343
Thrombocytopenia	24.11	10.17	122	61954	223679	64212977
Intentional product use issue	24.05	10.17	34	62042	95330	64341326
Paranoia	23.55	10.17	50	62026	16302	64420354
Rib fracture	23.26	10.17	63	62013	23975	64412681
Glossodynia	23.21	10.17	17	62059	64679	64371977
Gait spastic	23.19	10.17	13	62063	879	64435777
Withdrawal syndrome	23.17	10.17	62	62014	23430	64413226
Exposure via ingestion	23.10	10.17	26	62050	4876	64431780
Apnoea	22.65	10.17	38	62038	10384	64426272
Neutropenia	22.34	10.17	137	61939	239487	64197169
Pyrexia	22.29	10.17	391	61685	558253	63878403
Nasopharyngitis	22.21	10.17	105	61971	195968	64240688
Somnambulism	22.09	10.17	26	62050	5115	64431541
Infected dermal cyst	21.84	10.17	12	62064	780	64435876
Psychotic behaviour	21.46	10.17	13	62063	1016	64435640
Hypothermia	21.21	10.17	54	62022	19802	64416854
Ovarian cyst	21.11	10.17	38	62038	10980	64425676
Urticaria	21.03	10.17	72	62004	147245	64289411
Urine oxalate increased	20.92	10.17	8	62068	222	64436434
Restless legs syndrome	20.90	10.17	49	62027	17067	64419589
Arteriosclerosis coronary artery	20.67	10.17	46	62030	15483	64421173
Wound	20.57	10.17	26	62050	76451	64360205
Myelocyte percentage increased	20.24	10.17	8	62068	243	64436413
Bruxism	20.19	10.17	21	62055	3603	64433053
Band neutrophil percentage increased	19.71	10.17	9	62067	393	64436263
Depressed mood	19.69	10.17	85	61991	40927	64395729
Pulmonary oedema	19.39	10.17	136	61940	78538	64358118
Needle fatigue	19.29	10.17	10	62066	578	64436078
Systemic lupus erythematosus	19.24	10.17	28	62048	77584	64359072
Victim of crime	19.19	10.17	9	62067	418	64436238
Antasthmatic drug level	18.79	10.17	5	62071	40	64436616
Crystalluria	18.55	10.17	11	62065	827	64435829
Analgesic drug level	18.37	10.17	5	62071	44	64436612
C-reactive protein increased	18.34	10.17	40	62036	94869	64341787
Retinal depigmentation	18.32	10.17	8	62068	314	64436342
Behaviour disorder	18.24	10.17	22	62054	4440	64432216
COVID-19	17.67	10.17	22	62054	65118	64371538
Septic shock	17.57	10.17	48	62028	105389	64331267
Blister	17.46	10.17	32	62044	80935	64355721
Dystrophic calcification	17.44	10.17	6	62070	122	64436534
Alcohol poisoning	17.43	10.17	21	62055	4234	64432422
Drug resistance	17.42	10.17	6	62070	35096	64401560
Amnesia	17.34	10.17	92	61984	48177	64388479
Pruritus	17.23	10.17	205	61871	312195	64124461
Hepatic function abnormal	17.15	10.17	22	62054	64291	64372365
Cardiomegaly	17.14	10.17	56	62020	23628	64413028
Folliculitis	17.04	10.17	4	62072	30073	64406583
Congestive hepatopathy	16.92	10.17	20	62056	3953	64432703
Rectal polyp	16.52	10.17	12	62064	1272	64435384
Lethargy	16.46	10.17	123	61953	72471	64364185
Tremor	16.30	10.17	216	61860	148014	64288642
Thinking abnormal	16.25	10.17	35	62041	11521	64425135
Loss of consciousness	16.24	10.17	216	61860	148149	64288507
Therapeutic product effect decreased	16.04	10.17	57	62019	115294	64321362
Product use in unapproved indication	15.93	10.17	102	61974	176516	64260140
Cholestasis	15.83	10.17	12	62064	44860	64391796
Dilatation atrial	15.75	10.17	18	62058	3432	64433224
Relapsing-remitting multiple sclerosis	15.74	10.17	11	62065	1097	64435559
Osmolar gap abnormal	15.59	10.17	5	62071	81	64436575
Band neutrophil count increased	15.56	10.17	9	62067	646	64436010
Infection	15.56	10.17	109	61967	184771	64251885
Nightmare	15.52	10.17	50	62026	20943	64415713
Delusion	15.26	10.17	45	62031	17969	64418687
Oesophagitis ulcerative	15.21	10.17	10	62066	902	64435754
Accidental poisoning	15.19	10.17	12	62064	1441	64435215
Therapeutic product effect incomplete	15.16	10.17	50	62026	103432	64333224
Ventricular hypokinesia	15.15	10.17	27	62049	7742	64428914
Pneumocystis jirovecii pneumonia	15.02	10.17	4	62072	27630	64409026
Bundle branch block left	14.82	10.17	31	62045	10003	64426653
Stomatitis	14.69	10.17	55	62021	109550	64327106
Panic attack	14.68	10.17	49	62027	20904	64415752
Postmortem blood drug level increased	14.31	10.17	9	62067	752	64435904
Breast cancer male	14.25	10.17	6	62070	215	64436441
Duodenal ulcer	14.13	10.17	38	62038	14397	64422259
Patient uncooperative	14.03	10.17	8	62068	559	64436097
Mental impairment	14.02	10.17	41	62035	16302	64420354
Herpes zoster	13.99	10.17	35	62041	79152	64357504
Duodenal ulcer perforation	13.92	10.17	8	62068	34617	64402039
Myelosuppression	13.84	10.17	3	62073	23827	64412829
Arteriosclerosis	13.78	10.17	40	62036	15837	64420819
Diarrhoea	13.66	10.17	563	61513	722141	63714515
Mobility decreased	13.62	10.17	40	62036	85800	64350856
Accident	13.62	10.17	24	62052	6822	64429834
Agitation	13.39	10.17	137	61939	88230	64348426
Sensitisation	13.36	10.17	12	62064	1719	64434937
Sinusitis	13.30	10.17	84	61992	145844	64290812
Emotional disorder	13.17	10.17	34	62042	12573	64424083
Emotional distress	13.15	10.17	69	62007	35969	64400687
Analgesic drug level above therapeutic	13.15	10.17	7	62069	427	64436229
Cardiac asthma	13.14	10.17	6	62070	262	64436394
Anger	13.03	10.17	39	62037	15702	64420954
Opiates positive	12.95	10.17	9	62067	889	64435767
Anaemia	12.94	10.17	272	61804	378408	64058248
Fibrinolysis	12.88	10.17	4	62072	58	64436598
Condition aggravated	12.87	10.17	267	61809	372159	64064497
Tangentiality	12.77	10.17	5	62071	148	64436508
Gastrointestinal disorder	12.69	10.17	44	62032	89665	64346991
Bacterial test	12.69	10.17	10	62066	1197	64435459
Chronic obstructive pulmonary disease	12.67	10.17	114	61962	70934	64365722
Sexually inappropriate behaviour	12.66	10.17	7	62069	461	64436195
Dysprosody	12.48	10.17	3	62073	15	64436641
Upper respiratory tract congestion	12.43	10.17	13	62063	2245	64434411
Pancytopenia	12.29	10.17	84	61992	143225	64293431
Injury	12.20	10.17	94	61982	55898	64380758
Cardiac failure	12.16	10.17	76	62000	132297	64304359
Suspected counterfeit product	12.04	10.17	7	62069	507	64436149
Myelocyte count increased	11.95	10.17	8	62068	744	64435912
Liver injury	11.91	10.17	7	62069	29925	64406731
Mass	11.85	10.17	37	62039	15239	64421417
Mesothelioma	11.75	10.17	6	62070	336	64436320
Specific gravity urine decreased	11.65	10.17	8	62068	775	64435881
Blood pressure fluctuation	11.64	10.17	20	62056	51851	64384805
Change of bowel habit	11.60	10.17	13	62063	2425	64434231
Mucosal inflammation	11.58	10.17	27	62049	62557	64374099
Hypovolaemia	11.55	10.17	37	62039	15449	64421207
Neurotoxicity	11.49	10.17	6	62070	27398	64409258
Psoriatic arthropathy	11.34	10.17	15	62061	43266	64393390
Hyperlipidaemia	11.32	10.17	48	62028	22928	64413728
Hospitalisation	11.25	10.17	36	62040	75171	64361485
Confusional state	11.25	10.17	330	61746	260814	64175842
Injection site erythema	11.22	10.17	33	62043	70767	64365889
Cyclothymic disorder	11.18	10.17	5	62071	208	64436448
Transaminases increased	11.14	10.17	16	62060	44578	64392078
Drug eruption	11.12	10.17	11	62065	36125	64400531
Concussion	11.11	10.17	24	62052	7914	64428742
Conduction disorder	11.11	10.17	14	62062	2954	64433702
Hepatic steatosis	11.06	10.17	59	62017	30948	64405708
Hypertonic bladder	11.05	10.17	15	62061	3403	64433253
Akathisia	10.97	10.17	30	62046	11480	64425176
Intentional product misuse	10.91	10.17	112	61964	72183	64364473
Ill-defined disorder	10.81	10.17	16	62060	44036	64392620
Coronary artery disease	10.79	10.17	97	61979	60336	64376320
Muscle injury	10.78	10.17	6	62070	26431	64410225
Injection site pain	10.74	10.17	63	62013	111345	64325311
Musculoskeletal stiffness	10.67	10.17	72	62004	123134	64313522
Lip swelling	10.67	10.17	9	62067	31898	64404758
Ventricular hypertrophy	10.65	10.17	21	62055	6495	64430161
Gamma-glutamyltransferase increased	10.61	10.17	19	62057	48491	64388165
Respiratory rate decreased	10.60	10.17	17	62059	4474	64432182
Wrong technique in product usage process	10.51	10.17	30	62046	64944	64371712
Mania	10.46	10.17	37	62039	16249	64420407
Cardioactive drug level above therapeutic	10.41	10.17	5	62071	245	64436411
Shock	10.28	10.17	13	62063	38227	64398429
Subendocardial ischaemia	10.26	10.17	4	62072	117	64436539
Urine odour abnormal	10.21	10.17	18	62058	5118	64431538
Alopecia	10.20	10.17	106	61970	165584	64271072
Feeling abnormal	10.19	10.17	183	61893	133419	64303237

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N05CD07	NERVOUS SYSTEM PSYCHOLEPTICS HYPNOTICS AND SEDATIVES Benzodiazepine derivatives
FDA CS	M0002356	Benzodiazepines
MeSH PA	D014151	Anti-Anxiety Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D018682	GABA Agents
MeSH PA	D018757	GABA Modulators
MeSH PA	D006993	Hypnotics and Sedatives
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D011619	Psychotropic Drugs
MeSH PA	D014149	Tranquilizing Agents
FDA EPC	N0000175694	Benzodiazepine

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

Disease	Relation	SNOMED_ID	DOID
Insomnia	indication	193462001
Suicidal thoughts	contraindication	6471006
Alcohol intoxication	contraindication	25702006
Depressive disorder	contraindication	35489007
Substance abuse	contraindication	66214007
Sleep apnea	contraindication	73430006	DOID:0050847
Kidney disease	contraindication	90708001	DOID:557
Hypoalbuminemia	contraindication	119247004
Disease of liver	contraindication	235856003	DOID:409
Sleep automatism	contraindication	247962006
Pregnancy, function	contraindication	289908002
Severe chronic obstructive pulmonary disease	contraindication	313299006
Memory impairment	contraindication	386807006
Chronic lung disease	contraindication	413839001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.07	acidic
pKa2	1.46	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])	Mechanism action	Bioact source	MoA source
GABA-A receptor alpha-1/beta-2/gamma-2	Ion channel	P14867 P18507 P47870	GBRA1_HUMAN GBRG2_HUMAN GBRB2_HUMAN	POSITIVE ALLOSTERIC MODULATOR				WOMBAT-PK	CHEMBL
Nuclear receptor subfamily 1 group I member 3	Nuclear hormone receptor	Q14994	NR1I3_HUMAN					WOMBAT-PK

External reference:

ID	Source
4017894	VUID
N0000146246	NUI
D00370	KEGG_DRUG
4017894	VANDF
C0039468	UMLSCUI
CHEBI:9435	CHEBI
CHEMBL967	ChEMBL_ID
DB00231	DRUGBANK_ID
D013693	MESH_DESCRIPTOR_UI
5391	PUBCHEM_CID
7300	IUPHAR_LIGAND_ID
2753	INN_ID
CHB1QD2QSS	UNII
10355	RXNORM
2322	MMSL
5544	MMSL
d00384	MMSL
001450	NDDF
387300007	SNOMEDCT_US
54705000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2076	CAPSULE	15 mg	ORAL	ANDA	19 sections
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2077	CAPSULE	30 mg	ORAL	ANDA	19 sections
RESTORIL	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9914	CAPSULE	22.50 mg	ORAL	NDA	26 sections
RESTORIL	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9915	CAPSULE	7.50 mg	ORAL	NDA	26 sections
RESTORIL	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9916	CAPSULE	15 mg	ORAL	NDA	26 sections
RESTORIL	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9917	CAPSULE	30 mg	ORAL	NDA	26 sections
TEMAZEPAM	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9959	CAPSULE	22.50 mg	ORAL	NDA	26 sections
TEMAZEPAM	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9960	CAPSULE	7.50 mg	ORAL	NDA	26 sections
TEMAZEPAM	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9961	CAPSULE	15 mg	ORAL	NDA	26 sections
TEMAZEPAM	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9962	CAPSULE	30 mg	ORAL	NDA	26 sections
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7808	CAPSULE	15 mg	ORAL	ANDA	27 sections
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7809	CAPSULE	30 mg	ORAL	ANDA	27 sections
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6436	CAPSULE	7.50 mg	ORAL	ANDA	24 sections
TEMAZEPAM	HUMAN PRESCRIPTION DRUG LABEL	1	16590-214	CAPSULE	15 mg	ORAL	ANDA	14 sections
temazepam	Human Prescription Drug Label	1	17856-0148	CAPSULE	15 mg	ORAL	ANDA	23 sections
temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	21695-282	CAPSULE	15 mg	ORAL	ANDA	24 sections
temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	21695-283	CAPSULE	30 mg	ORAL	ANDA	24 sections
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	33261-101	CAPSULE	15 mg	ORAL	ANDA	23 sections
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	33261-102	CAPSULE	30 mg	ORAL	ANDA	23 sections
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	33358-332	CAPSULE	15 mg	ORAL	ANDA	18 sections
temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	35356-663	CAPSULE	30 mg	ORAL	ANDA	23 sections
temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	35356-663	CAPSULE	30 mg	ORAL	ANDA	23 sections
temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	35356-664	CAPSULE	15 mg	ORAL	ANDA	23 sections
temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	35356-664	CAPSULE	15 mg	ORAL	ANDA	23 sections
temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	35356-821	CAPSULE	22.50 mg	ORAL	ANDA	23 sections
temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	35356-821	CAPSULE	22.50 mg	ORAL	ANDA	23 sections
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	40032-120	CAPSULE	7.50 mg	ORAL	ANDA	17 sections
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	40032-121	CAPSULE	15 mg	ORAL	ANDA	17 sections
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	40032-122	CAPSULE	22.50 mg	ORAL	ANDA	17 sections
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	40032-123	CAPSULE	30 mg	ORAL	ANDA	17 sections