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

Stem definition	Drug id	CAS RN
	1745	60-56-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: methimazole methylimidazolethiol thyrozol thymidazole thymidazol thycapzol thiamazole tapazole methymazol	A thioureylene antithyroid agent that inhibits the formation of thyroid hormones by interfering with the incorporation of iodine into tyrosyl residues of thyroglobulin. This is done by interfering with the oxidation of iodide ion and iodotyrosyl groups through inhibition of the peroxidase enzyme. Molecular weight: 114.17 Formula: C4H6N2S CLOGP: -0.34 LIPINSKI: 0 HAC: 2 HDO: 1 TPSA: 15.27 ALOGS: -1 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

methimazole
methylimidazolethiol
thyrozol
thymidazole
thymidazol
thycapzol
thiamazole
tapazole
methymazol

A thioureylene antithyroid agent that inhibits the formation of thyroid hormones by interfering with the incorporation of iodine into tyrosyl residues of thyroglobulin. This is done by interfering with the oxidation of iodide ion and iodotyrosyl groups through inhibition of the peroxidase enzyme.

Molecular weight: 114.17
Formula: C4H6N2S
CLOGP: -0.34
LIPINSKI: 0
HAC: 2
HDO: 1
TPSA: 15.27
ALOGS: -1
ROTB: 0

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
MRTD (Maximum Recommended Therapeutic Daily Dose)	8.76 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Hosey CM, Chan R, Benet LZ
BA (Bioavailability)	93 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.86 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	3.70 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2.40 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	200 mg/mL	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
June 21, 1950	FDA

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
Agranulocytosis	402.51	14.05	149	9454	24985	63454434
Thyrotoxic crisis	295.04	14.05	58	9545	818	63478601
Hyperthyroidism	231.10	14.05	86	9517	14587	63464832
Antithyroid arthritis syndrome	74.61	14.05	10	9593	4	63479415
Hypothyroidism	69.47	14.05	55	9548	42577	63436842
Choanal atresia	59.65	14.05	9	9594	20	63479399
Exophthalmos	43.80	14.05	14	9589	1502	63477917
Neutropenia	40.81	14.05	85	9518	174920	63304499
Blood thyroid stimulating hormone decreased	38.08	14.05	17	9586	4573	63474846
Drug-induced liver injury	34.14	14.05	36	9567	40186	63439233
Jaundice cholestatic	33.31	14.05	18	9585	7306	63472113
Anti-neutrophil cytoplasmic antibody positive vasculitis	31.51	14.05	13	9590	2886	63476533
Goitre	30.93	14.05	16	9587	5945	63473474
Dysmorphism	30.87	14.05	12	9591	2284	63477135
Thyroxine free increased	29.02	14.05	9	9594	875	63478544
Cardiac arrest	27.72	14.05	50	9553	92495	63386924
Cardiac failure	26.49	14.05	48	9555	89094	63390325
Mucocutaneous candidiasis	25.90	14.05	4	9599	11	63479408
Pulmonary alveolar haemorrhage	25.58	14.05	13	9590	4655	63474764
Aplasia cutis congenita	25.52	14.05	5	9598	69	63479350
Polyarthritis	25.43	14.05	17	9586	10129	63469290
Arthropathy	25.16	14.05	3	9600	234789	63244630
Drug intolerance	24.65	14.05	8	9595	308653	63170766
Functional residual capacity increased	24.17	14.05	5	9598	92	63479327
Insulin autoimmune syndrome	23.37	14.05	5	9598	109	63479310
Oropharyngeal pain	23.30	14.05	47	9556	94440	63384979
Toxic nodular goitre	23.27	14.05	4	9599	25	63479394
Respiratory syncytial virus infection	23.18	14.05	14	9589	7004	63472415
Endocrine ophthalmopathy	22.74	14.05	7	9596	664	63478755
Drug interaction	22.53	14.05	81	9522	229050	63250369
Stevens-Johnson syndrome	22.36	14.05	23	9580	24927	63454492
Thyroid disorder	21.39	14.05	18	9585	15144	63464275
Eosinophilic pleural effusion	20.86	14.05	4	9599	49	63479370
Contraindicated product administered	20.53	14.05	4	9599	217644	63261775
Acquired epidermolysis bullosa	20.36	14.05	4	9599	56	63479363
Hypoglycaemia	19.99	14.05	34	9569	60031	63419388
Atrial fibrillation	19.78	14.05	50	9553	116586	63362833
Systemic lupus erythematosus	19.37	14.05	4	9599	208914	63270505
Sopor	19.09	14.05	20	9583	22144	63457275
Thyroid haemorrhage	19.07	14.05	4	9599	79	63479340
Thyroidectomy	19.04	14.05	7	9596	1143	63478276
Hypersensitivity vasculitis	18.40	14.05	10	9593	4102	63475317
Hepatitis cholestatic	18.39	14.05	12	9591	6866	63472553
Febrile neutropenia	18.27	14.05	49	9554	118400	63361019
Exposure during pregnancy	17.92	14.05	58	9545	155489	63323930
Rheumatoid arthritis	17.89	14.05	8	9595	253811	63225608
Symptom masked	17.85	14.05	6	9597	753	63478666
Electrocardiogram QT prolonged	17.61	14.05	32	9571	59498	63419921
Toxic goitre	17.56	14.05	3	9600	18	63479401
Multiple organ dysfunction syndrome	17.42	14.05	31	9572	56721	63422698
Therapeutic product effect decreased	17.30	14.05	4	9599	193183	63286236
Clinodactyly	17.19	14.05	4	9599	129	63479290
Thyroxine free abnormal	17.03	14.05	3	9600	22	63479397
Neuroglycopenia	16.26	14.05	5	9598	473	63478946
Spigelian hernia	15.78	14.05	3	9600	35	63479384
Microscopic polyangiitis	15.75	14.05	4	9599	187	63479232
Metabolic function test abnormal	15.53	14.05	4	9599	198	63479221
Autoimmune neutropenia	15.45	14.05	4	9599	202	63479217
Kidney transplant rejection	15.36	14.05	9	9594	4262	63475157
Acute generalised exanthematous pustulosis	15.30	14.05	13	9590	11086	63468333
Epiphysiolysis	15.14	14.05	3	9600	44	63479375
Tri-iodothyronine free increased	15.08	14.05	4	9599	222	63479197
Disorganised speech	14.87	14.05	6	9597	1259	63478160
Systemic candida	14.82	14.05	8	9595	3237	63476182
Product administered to patient of inappropriate age	14.77	14.05	8	9595	3260	63476159
Anaemia	14.70	14.05	85	9518	293345	63186074
Synovitis	14.64	14.05	5	9598	186913	63292506
Joint swelling	14.43	14.05	17	9586	327649	63151770
Renal infarct	14.09	14.05	6	9597	1441	63477978

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
Hyperthyroidism	182.86	18.47	63	4264	10503	34942101
Thyrotoxic periodic paralysis	126.86	18.47	21	4306	128	34952476
Agranulocytosis	86.31	18.47	47	4280	23774	34928830
Thyrotoxic crisis	75.94	18.47	16	4311	399	34952205
Hypothyroidism	61.50	18.47	36	4291	20866	34931738
Polymerase chain reaction	43.55	18.47	8	4319	95	34952509
Kounis syndrome	43.44	18.47	15	4312	2503	34950101
Product administered to patient of inappropriate age	35.95	18.47	14	4313	3277	34949327
Albumin urine present	33.06	18.47	8	4319	376	34952228
Exomphalos	32.01	18.47	7	4320	209	34952395
Urine leukocyte esterase positive	31.44	18.47	8	4319	463	34952141
Haemoglobinuria	29.32	18.47	8	4319	607	34951997
Cholestatic liver injury	29.20	18.47	11	4316	2353	34950251
Goitre	28.96	18.47	10	4317	1668	34950936
Pericarditis fungal	28.23	18.47	6	4321	156	34952448
Mouth swelling	27.98	18.47	10	4317	1846	34950758
Urinary bladder rupture	25.33	18.47	5	4322	89	34952515
Urine ketone body present	24.40	18.47	8	4319	1140	34951464
Autoimmune thyroiditis	24.22	18.47	8	4319	1166	34951438
Glycosuria	23.81	18.47	8	4319	1229	34951375
Respiratory tract haemorrhage	23.60	18.47	8	4319	1262	34951342
Axial spondyloarthritis	23.60	18.47	6	4321	346	34952258
Drug-induced liver injury	23.47	18.47	23	4304	28809	34923795
Loss of proprioception	22.84	18.47	6	4321	394	34952210
Blood cyanide increased	22.06	18.47	4	4323	44	34952560
Tracheo-oesophageal fistula	21.83	18.47	6	4321	468	34952136
Coagulation time shortened	20.90	18.47	5	4322	224	34952380
Pulseless electrical activity	20.09	18.47	12	4315	7199	34945405
Cardiogenic shock	19.40	18.47	20	4307	26598	34926006
Blood sodium decreased	19.21	18.47	16	4311	16235	34936369
Thyroid operation	18.79	18.47	3	4324	14	34952590

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
Agranulocytosis	432.45	13.20	187	12430	44843	79686928
Thyrotoxic crisis	339.36	13.20	70	12547	1214	79730557
Hyperthyroidism	318.40	13.20	123	12494	22086	79709685
Thyrotoxic periodic paralysis	120.05	13.20	21	12596	140	79731631
Hypothyroidism	109.86	13.20	80	12537	52312	79679459
Antithyroid arthritis syndrome	74.16	13.20	10	12607	4	79731767
Exophthalmos	49.38	13.20	16	12601	1714	79730057
Drug-induced liver injury	46.82	13.20	55	12562	66062	79665709
Goitre	46.60	13.20	21	12596	5518	79726253
Anti-neutrophil cytoplasmic antibody positive vasculitis	44.13	13.20	18	12599	3711	79728060
Polymerase chain reaction	39.67	13.20	8	12609	123	79731648
Product administered to patient of inappropriate age	37.25	13.20	18	12599	5535	79726236
Cardiac failure	36.94	13.20	78	12539	154764	79577007
Jaundice cholestatic	32.56	13.20	21	12596	11263	79720508
Kounis syndrome	32.15	13.20	15	12602	4267	79727504
Cardiac arrest	31.42	13.20	78	12539	172018	79559753
Endocrine ophthalmopathy	30.34	13.20	9	12608	719	79731052
Toxic goitre	29.18	13.20	5	12612	29	79731742
Pulseless electrical activity	28.25	13.20	21	12596	14139	79717632
Blood thyroid stimulating hormone decreased	28.04	13.20	15	12602	5701	79726070
Neutropenia	26.76	13.20	103	12514	287607	79444164
Albumin urine present	26.46	13.20	8	12609	683	79731088
Hepatitis cholestatic	26.43	13.20	20	12597	13832	79717939
Polyarthritis	26.39	13.20	19	12598	12183	79719588
Pericarditis fungal	25.87	13.20	6	12611	182	79731589
Thyroxine free increased	25.69	13.20	9	12608	1223	79730548
Atrial fibrillation	25.52	13.20	79	12538	197807	79533964
Haemoglobinuria	25.39	13.20	8	12609	783	79730988
Drug intolerance	24.19	13.20	6	12611	264113	79467658
Functional residual capacity increased	23.75	13.20	5	12612	96	79731675
Autoimmune thyroiditis	23.30	13.20	12	12605	4221	79727550
Drug interaction	23.23	13.20	128	12489	415055	79316716
Urinary bladder rupture	22.97	13.20	5	12612	113	79731658
Cardiogenic shock	21.93	13.20	30	12587	41884	79689887
Blood cyanide increased	21.08	13.20	4	12613	44	79731727
Pulmonary alveolar haemorrhage	20.67	13.20	16	12601	11441	79720330
Completed suicide	19.92	13.20	7	12610	245760	79486011
Thyroiditis	19.59	13.20	11	12606	4594	79727177
Hepatitis	19.39	13.20	33	12584	55694	79676077
Respiratory syncytial virus infection	18.88	13.20	14	12603	9388	79722383
Respiratory tract haemorrhage	18.87	13.20	8	12609	1815	79729956
Cholestatic liver injury	18.87	13.20	11	12606	4930	79726841
Electrocardiogram QT prolonged	18.67	13.20	43	12574	90343	79641428
Arthropathy	18.34	13.20	3	12614	177108	79554663
Mucocutaneous candidiasis	18.19	13.20	4	12613	95	79731676
Tonsillitis	18.16	13.20	12	12605	6702	79725069
Urine leukocyte esterase positive	18.03	13.20	10	12607	4081	79727690
Thyroid haemorrhage	17.84	13.20	4	12613	104	79731667
Sopor	17.84	13.20	24	12593	32986	79698785
Acquired epidermolysis bullosa	17.66	13.20	4	12613	109	79731662
Glycosuria	17.47	13.20	8	12609	2180	79729591
Coagulation time shortened	16.77	13.20	5	12612	407	79731364
Insulin autoimmune syndrome	16.53	13.20	5	12612	427	79731344
Jaundice	16.50	13.20	30	12587	53319	79678452
Thyroidectomy	16.32	13.20	6	12611	936	79730835
Oropharyngeal pain	16.32	13.20	46	12571	109307	79622464
Thyroid dermatopathy	16.16	13.20	3	12614	29	79731742
Neuroglycopenia	15.97	13.20	5	12612	479	79731292
Tonsillitis bacterial	15.94	13.20	4	12613	170	79731601
Product use in unapproved indication	15.91	13.20	80	12537	250279	79481492
Ventricular septal defect	15.61	13.20	5	12612	516	79731255
Antineutrophil cytoplasmic antibody	15.57	13.20	3	12614	36	79731735
Hypersensitivity vasculitis	15.45	13.20	11	12606	6932	79724839
Infusion related reaction	14.88	13.20	9	12608	230228	79501543
Toxic nodular goitre	14.71	13.20	3	12614	49	79731722
Metabolic function test abnormal	14.65	13.20	4	12613	237	79731534
Synovitis	14.65	13.20	3	12614	150731	79581040
Exposure during pregnancy	14.56	13.20	42	12575	101090	79630681
Pericardial haemorrhage	14.56	13.20	9	12608	4486	79727285
Cholestasis	14.49	13.20	28	12589	52081	79679690
Therapeutic product effect decreased	14.47	13.20	4	12613	163859	79567912
Mouth swelling	14.42	13.20	10	12607	6041	79725730
Tri-iodothyronine increased	14.40	13.20	4	12613	253	79731518
Tri-iodothyronine free increased	14.26	13.20	4	12613	262	79731509
Premature delivery	14.14	13.20	18	12599	23449	79708322
Symptom masked	14.06	13.20	6	12611	1384	79730387
Pure white cell aplasia	13.82	13.20	3	12614	67	79731704
Urine ketone body present	13.78	13.20	8	12609	3557	79728214
Immune-mediated hepatitis	13.60	13.20	8	12609	3648	79728123
Hypoglycaemia	13.49	13.20	41	12576	101553	79630218
Pleural effusion	13.47	13.20	52	12565	145210	79586561
Eosinophilic pleural effusion	13.30	13.20	4	12613	335	79731436

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	H03BB02	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS THYROID THERAPY ANTITHYROID PREPARATIONS Sulfur-containing imidazole derivatives
ATC	H03BB52	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS THYROID THERAPY ANTITHYROID PREPARATIONS Sulfur-containing imidazole derivatives
MeSH PA	D013956	Antithyroid Agents
MeSH PA	D006727	Hormone Antagonists
FDA MoA	N0000175917	Thyroid Hormone Synthesis Inhibitors
FDA EPC	N0000175918	Thyroid Hormone Synthesis Inhibitor
CHEBI has role	CHEBI:50671	antithyroid drugs

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

Disease	Relation	SNOMED_ID	DOID
Hyperthyroidism	indication	34486009	DOID:7998
Thyrotoxic crisis	off-label use	29028009	DOID:12837
Agranulocytosis	contraindication	17182001	DOID:12987
Hypothyroidism	contraindication	40930008	DOID:1459
Factor II deficiency	contraindication	73975000
Leukopenia	contraindication	84828003	DOID:615
Pancytopenia	contraindication	127034005	DOID:12450
Liver function tests abnormal	contraindication	166603001
Drug-induced hepatitis	contraindication	235876009
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Bone marrow depression	contraindication	307762000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

Product	Applicant	Ingredients
Felimazole	Dechra, Ltd.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.7	acidic

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
Thyroid peroxidase	Enzyme	P07202	PERT_HUMAN	INHIBITOR	IC50	5.57	WOMBAT-PK	CHEMBL
Lactoperoxidase	Enzyme	P22079	PERL_HUMAN		IC50	4.93	CHEMBL
Taste receptor type 2 member 38	GPCR	P59533	T2R38_HUMAN	AGONIST	EC50	4.01	IUPHAR
Lactoperoxidase	Enzyme		PERL_BOVIN		IC50	5.08	CHEMBL
Dopamine beta-hydroxylase	Enzyme		DOPO_BOVIN		Ki	4.35	CHEMBL

External reference:

ID	Source
4017434	VUID
N0000145822	NUI
D00401	KEGG_DRUG
4017434	VANDF
C0025644	UMLSCUI
CHEBI:50673	CHEBI
MMZ	PDB_CHEM_ID
CHEMBL1515	ChEMBL_ID
DB00763	DRUGBANK_ID
6649	IUPHAR_LIGAND_ID
1349907	PUBCHEM_CID
224936	RXNORM
2293	MMSL
31962	MMSL
5073	MMSL
d00290	MMSL
002139	NDDF
37656002	SNOMEDCT_US
404864000	SNOMEDCT_US
D008713	MESH_DESCRIPTOR_UI
4198	INN_ID
554Z48XN5E	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	0185-0205	TABLET	5 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	0185-0210	TABLET	10 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	23155-070	TABLET	5 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	23155-070	TABLET	5 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	23155-071	TABLET	10 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	23155-071	TABLET	10 mg	ORAL	ANDA	19 sections
Methimazole	Human Prescription Drug Label	1	33342-335	TABLET	5 mg	ORAL	ANDA	19 sections
Methimazole	Human Prescription Drug Label	1	33342-336	TABLET	10 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	42254-008	TABLET	5 mg	ORAL	ANDA	18 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	42254-009	TABLET	10 mg	ORAL	ANDA	18 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	49884-640	TABLET	5 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	49884-640	TABLET	5 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	49884-641	TABLET	10 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	49884-641	TABLET	10 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	50090-2366	TABLET	5 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3334	TABLET	5 mg	ORAL	ANDA	20 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	50090-6536	TABLET	5 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	51293-820	TABLET	5 mg	ORAL	ANDA	18 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	51293-821	TABLET	10 mg	ORAL	ANDA	18 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0850	TABLET	10 mg	ORAL	ANDA	18 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0949	TABLET	10 mg	ORAL	ANDA	18 sections
METHIMAZOLE	HUMAN PRESCRIPTION DRUG LABEL	1	53808-1044	TABLET	10 mg	ORAL	ANDA	18 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5135	TABLET	10 mg	ORAL	ANDA	18 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6071	TABLET	5 mg	ORAL	ANDA	18 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	60429-380	TABLET	5 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	60429-380	TABLET	5 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	60429-381	TABLET	10 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	60429-381	TABLET	10 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	60687-357	TABLET	5 mg	ORAL	ANDA	19 sections
Methimazole	HUMAN PRESCRIPTION DRUG LABEL	1	60687-357	TABLET	5 mg	ORAL	ANDA	19 sections