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

Stem definition	Drug id	CAS RN
ergot alkaloid derivatives	460	81409-90-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: cabergoline dostinex galastop cabaser cabaseril	An ergoline derivative and dopamine D2-agonist that inhibits PROLACTIN secretion. It is used in the management of HYPERPROLACTINEMIA, and to suppress lactation following childbirth for medical reasons. Cabergoline is also used in the management of PARKINSON DISEASE. Molecular weight: 451.62 Formula: C26H37N5O2 CLOGP: 4.17 LIPINSKI: 0 HAC: 7 HDO: 2 TPSA: 71.68 ALOGS: -3.85 ROTB: 8 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

cabergoline
dostinex
galastop
cabaser
cabaseril

An ergoline derivative and dopamine D2-agonist that inhibits PROLACTIN secretion. It is used in the management of HYPERPROLACTINEMIA, and to suppress lactation following childbirth for medical reasons. Cabergoline is also used in the management of PARKINSON DISEASE.

Molecular weight: 451.62
Formula: C26H37N5O2
CLOGP: 4.17
LIPINSKI: 0
HAC: 7
HDO: 2
TPSA: 71.68
ALOGS: -3.85
ROTB: 8

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.50	mg	O
3	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)	3 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.01 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	65 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Dec. 23, 1996	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
Blood growth hormone increased	180.28	18.51	34	7210	403	50597477
Insulin-like growth factor increased	159.02	18.51	34	7210	784	50597096
Aortic valve incompetence	114.26	18.51	39	7205	5437	50592443
Insulin-like growth factor decreased	86.80	18.51	18	7226	356	50597524
Ovarian hyperstimulation syndrome	83.21	18.51	27	7217	3217	50594663
Pituitary tumour	81.84	18.51	20	7224	845	50597035
Blood prolactin increased	76.28	18.51	25	7219	3074	50594806
Needle issue	61.98	18.51	27	7217	7248	50590632
Coronary artery dissection	59.68	18.51	15	7229	712	50597168
Mitral valve incompetence	57.30	18.51	34	7210	17437	50580443
Blood prolactin decreased	55.99	18.51	9	7235	37	50597843
Pituitary haemorrhage	50.06	18.51	9	7235	80	50597800
Inappropriate schedule of product administration	49.34	18.51	56	7188	71775	50526105
Pituitary tumour benign	46.39	18.51	15	7229	1766	50596114
Pulmonary pain	46.38	18.51	16	7228	2299	50595581
Acromegaly	40.05	18.51	7	7237	52	50597828
Cardiac valve disease	38.72	18.51	16	7228	3770	50594110
Mediastinal fibrosis	37.66	18.51	6	7238	23	50597857
Tricuspid valve incompetence	37.10	18.51	23	7221	12747	50585133
Bite	37.02	18.51	9	7235	372	50597508
Prolactin-producing pituitary tumour	36.30	18.51	7	7237	94	50597786
Pneumocephalus	33.72	18.51	7	7237	139	50597741
Cerebrospinal fluid leakage	33.31	18.51	10	7234	922	50596958
Overweight	31.42	18.51	13	7231	3073	50594807
Hypogonadism	30.49	18.51	6	7238	90	50597790
Diabetes mellitus	29.93	18.51	36	7208	48997	50548883
Neoplasm progression	29.51	18.51	28	7216	29129	50568751
Urine calcium/creatinine ratio increased	29.16	18.51	6	7238	114	50597766
Blood pressure increased	27.99	18.51	60	7184	133072	50464808
Mastitis	27.72	18.51	11	7233	2336	50595544
Kounis syndrome	26.99	18.51	9	7235	1166	50596714
Compulsive shopping	26.94	18.51	8	7236	710	50597170
Gambling disorder	26.85	18.51	9	7235	1185	50596695
Abortion spontaneous	26.04	18.51	31	7213	41741	50556139
Injection site mass	26.01	18.51	20	7224	15660	50582220
Urethral caruncle	24.88	18.51	5	7239	84	50597796
Aortic valve sclerosis	24.03	18.51	8	7236	1032	50596848
Camptocormia	23.66	18.51	6	7238	295	50597585
Cholelithiasis	23.37	18.51	28	7216	37945	50559935
Delusion	23.26	18.51	16	7228	10553	50587327
Memory impairment	23.04	18.51	41	7203	79319	50518561
Death	22.88	18.51	9	7235	325370	50272510
Blood growth hormone abnormal	22.51	18.51	4	7240	33	50597847
Empty sella syndrome	22.41	18.51	4	7240	34	50597846
Blood parathyroid hormone increased	22.39	18.51	10	7234	2844	50595036
Ovarian rupture	22.10	18.51	4	7240	37	50597843
Blood thyroid stimulating hormone decreased	21.65	18.51	11	7233	4161	50593719
Application site mass	21.56	18.51	4	7240	43	50597837
Dopamine dysregulation syndrome	21.48	18.51	5	7239	171	50597709
Chikungunya virus infection	21.23	18.51	5	7239	180	50597700
Hypopituitarism	21.12	18.51	7	7237	890	50596990
Blood sodium increased	20.73	18.51	9	7235	2393	50595487
Neoplasm	20.65	18.51	12	7232	5916	50591964
Toxicity to various agents	20.52	18.51	3	7241	212496	50385384
Arteriovenous fistula	19.98	18.51	5	7239	233	50597647
Galactorrhoea	19.86	18.51	10	7234	3713	50594167
Headache	19.84	18.51	132	7112	506403	50091477
Pituitary tumour recurrent	19.75	18.51	4	7240	70	50597810
Dengue fever	19.42	18.51	6	7238	609	50597271
Vitamin B12 decreased	19.36	18.51	9	7235	2806	50595074
Normal newborn	19.30	18.51	12	7232	6679	50591201
Nocturia	19.24	18.51	12	7232	6718	50591162
Blood gonadotrophin decreased	18.73	18.51	3	7241	12	50597868
Adjacent segment degeneration	18.73	18.51	3	7241	12	50597868
Mitral valve disease	18.68	18.51	8	7236	2058	50595822

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
Cerebrospinal fluid leakage	260.63	20.53	46	4240	361	29569880
Gambling disorder	182.70	20.53	43	4243	1532	29568709
Insulin-like growth factor increased	127.09	20.53	30	4256	1081	29569160
Aortic valve incompetence	101.48	20.53	35	4251	4978	29565263
Pneumocephalus	89.17	20.53	15	4271	85	29570156
Mitral valve incompetence	77.39	20.53	38	4248	13255	29556986
Visual pathway disorder	76.37	20.53	11	4275	16	29570225
Pituitary haemorrhage	73.22	20.53	14	4272	177	29570064
Needle issue	55.26	20.53	22	4264	4661	29565580
Empty sella syndrome	55.14	20.53	9	4277	41	29570200
Secondary hypogonadism	50.45	20.53	11	4275	275	29569966
Blood growth hormone increased	50.37	20.53	11	4275	277	29569964
Neoplasm progression	49.95	20.53	32	4254	18580	29551661
Jealous delusion	47.99	20.53	10	4276	200	29570041
Prolactin-producing pituitary tumour	44.25	20.53	7	4279	25	29570216
Cardiac valve disease	42.96	20.53	16	4270	2832	29567409
Hormone level abnormal	42.85	20.53	10	4276	342	29569899
Pituitary tumour	39.10	20.53	10	4276	503	29569738
Pleural effusion	39.02	20.53	50	4236	71858	29498383
Tricuspid valve incompetence	37.25	20.53	20	4266	8374	29561867
Intracranial hypotension	36.28	20.53	8	4278	211	29570030
Cortisol free urine increased	34.05	20.53	5	4281	9	29570232
Pleural fibrosis	33.65	20.53	11	4275	1324	29568917
Blood corticotrophin increased	32.06	20.53	6	4280	67	29570174
Glucose tolerance decreased	31.59	20.53	6	4280	73	29570168
Gambling	31.55	20.53	7	4279	190	29570051
Impulse-control disorder	30.50	20.53	10	4276	1215	29569026
Acromegaly	29.62	20.53	5	4281	29	29570212
Therapeutic response decreased	29.18	20.53	26	4260	24685	29545556
Autoimmune thyroiditis	28	20.53	9	4277	1027	29569214
Dopamine dysregulation syndrome	27.98	20.53	7	4279	322	29569919
Borderline personality disorder	27.75	20.53	7	4279	333	29569908
Hemianopia	27.60	20.53	8	4278	645	29569596
Injection site pain	26.72	20.53	28	4258	32418	29537823
Priapism	26.61	20.53	13	4273	4475	29565766
IIIrd nerve paralysis	25.76	20.53	7	4279	446	29569795
Hypersexuality	25.62	20.53	9	4277	1347	29568894
Persecutory delusion	25.05	20.53	10	4276	2131	29568110
Injection site erosion	24.99	20.53	5	4281	81	29570160
Blood prolactin increased	24.54	20.53	9	4277	1525	29568716
Reversible cerebral vasoconstriction syndrome	24.26	20.53	6	4280	263	29569978
Cardiomegaly	23.61	20.53	18	4268	13758	29556483
Death	22.19	20.53	11	4275	342073	29228168
Blood testosterone decreased	22.15	20.53	11	4275	3919	29566322
Aortic valve sclerosis	21.83	20.53	7	4279	793	29569448
Therapeutic product effect decreased	21.76	20.53	24	4262	29427	29540814
Renal haematoma	20.83	20.53	6	4280	473	29569768

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
Cerebrospinal fluid leakage	235.76	16.04	52	10114	1260	64487306
Insulin-like growth factor increased	213.26	16.04	50	10116	1602	64486964
Blood growth hormone increased	182.70	16.04	37	10129	585	64487981
Aortic valve incompetence	159.60	16.04	57	10109	8244	64480322
Gambling disorder	151.40	16.04	39	10127	1855	64486711
Pneumocephalus	124.03	16.04	23	10143	222	64488344
Pituitary haemorrhage	113.21	16.04	22	10144	278	64488288
Mitral valve incompetence	106.29	16.04	60	10106	25478	64463088
Needle issue	100.59	16.04	42	10124	9230	64479336
Blood prolactin increased	90.24	16.04	30	10136	3498	64485068
Pituitary tumour	84.63	16.04	22	10144	1084	64487482
Ovarian hyperstimulation syndrome	80.04	16.04	26	10140	2819	64485747
Insulin-like growth factor decreased	72.59	16.04	17	10149	541	64488025
Visual pathway disorder	70.93	16.04	12	10154	64	64488502
Empty sella syndrome	70.62	16.04	12	10154	66	64488500
Acromegaly	69.73	16.04	12	10154	72	64488494
Tricuspid valve incompetence	68.18	16.04	39	10127	16964	64471602
Prolactin-producing pituitary tumour	58.96	16.04	11	10155	110	64488456
Cardiac valve disease	57.92	16.04	24	10142	5171	64483395
Coronary artery dissection	54.90	16.04	15	10151	895	64487671
Pulmonary pain	54.44	16.04	19	10147	2565	64486001
Neoplasm progression	52.84	16.04	47	10119	40917	64447649
Intracranial hypotension	52.45	16.04	12	10154	344	64488222
Secondary hypogonadism	52.38	16.04	12	10154	346	64488220
Diabetes mellitus	46.77	16.04	55	10111	66419	64422147
Hormone level abnormal	45.51	16.04	15	10151	1702	64486864
Pituitary tumour benign	45.02	16.04	16	10150	2277	64486289
Blood pressure increased	42.71	16.04	88	10078	172464	64316102
Acute kidney injury	41.42	16.04	10	10156	449230	64039336
Jealous delusion	40.79	16.04	9	10157	218	64488348
Blood growth hormone abnormal	40.68	16.04	7	10159	42	64488524
Dopamine dysregulation syndrome	38.94	16.04	10	10156	469	64488097
Toxicity to various agents	37.89	16.04	6	10160	363507	64125059
Mediastinal fibrosis	37.74	16.04	6	10160	20	64488546
Death	35.31	16.04	16	10150	482689	64005877
Bite	35.11	16.04	9	10157	419	64488147
Gambling	33.40	16.04	8	10158	281	64488285
Inappropriate schedule of product administration	32.78	16.04	55	10111	92231	64396335
Pituitary enlargement	32.53	16.04	6	10160	56	64488510
Delusion	32.25	16.04	25	10141	17989	64470577
Aortic valve sclerosis	30.93	16.04	11	10155	1568	64486998
Glucose tolerance decreased	30.86	16.04	6	10160	76	64488490
Pleural fibrosis	29.88	16.04	14	10152	4036	64484530
Mitral valve disease	28.77	16.04	12	10154	2626	64485940
Headache	28.55	16.04	161	10005	529306	63959260
Cardiomegaly	28.22	16.04	26	10140	23658	64464908
Hallucination	28.03	16.04	45	10121	72743	64415823
Neoplasm	27.84	16.04	16	10150	7015	64481551
Injection site pain	27.75	16.04	57	10109	111351	64377215
Urine calcium/creatinine ratio increased	27.32	16.04	6	10160	142	64488424
Priapism	27.07	16.04	13	10153	3957	64484609
Reversible cerebral vasoconstriction syndrome	26.71	16.04	11	10155	2331	64486235
Injection site mass	26.71	16.04	22	10144	17248	64471318
Tricuspid valve disease	26.17	16.04	7	10159	385	64488181
Visual field defect	25.66	16.04	16	10150	8130	64480436
Carotid aneurysm rupture	25.24	16.04	4	10162	13	64488553
Urethral caruncle	24.99	16.04	5	10161	74	64488492
Hypersexuality	24.12	16.04	9	10157	1470	64487096
Blood pressure systolic increased	23.91	16.04	34	10132	49419	64439147
Persecutory delusion	23.55	16.04	12	10154	4146	64484420
Aortic valve disease	23.47	16.04	9	10157	1584	64486982
Cardiac valve sclerosis	23.25	16.04	5	10161	107	64488459
Sleep apnoea syndrome	23.19	16.04	26	10140	29806	64458760
Injection site erosion	22.82	16.04	5	10161	117	64488449
Ovarian rupture	22.47	16.04	4	10162	30	64488536
Pituitary tumour recurrent	22.32	16.04	5	10161	130	64488436
Blindness	22.12	16.04	22	10144	21997	64466569
Pleural effusion	21.82	16.04	56	10110	126503	64362063
Mastitis	21.69	16.04	9	10157	1945	64486621
Compulsive shopping	21.45	16.04	7	10159	770	64487796
Drug resistance	21.36	16.04	27	10139	35075	64453491
Heart rate decreased	21.14	16.04	34	10132	55033	64433533
Blood testosterone decreased	20.96	16.04	9	10157	2116	64486450
Body temperature decreased	20.84	16.04	23	10143	25905	64462661
Cortisol free urine increased	20.77	16.04	4	10162	48	64488518
Camptocormia	20.31	16.04	6	10160	475	64488091
Normal newborn	20.17	16.04	12	10154	5605	64482961
Pneumonia	20.08	16.04	36	10130	559540	63929026
Impulse-control disorder	19.97	16.04	8	10158	1580	64486986
Sepsis	19.55	16.04	6	10160	230335	64258231
Autoimmune thyroiditis	19.46	16.04	10	10156	3518	64485048
IIIrd nerve paralysis	19.23	16.04	7	10159	1067	64487499
Memory impairment	19.20	16.04	42	10124	85640	64402926
Mitral valve sclerosis	18.89	16.04	5	10161	264	64488302
Blood prolactin decreased	18.89	16.04	5	10161	264	64488302
Oncologic complication	18.79	16.04	5	10161	270	64488296
Performance enhancing product use	18.63	16.04	4	10162	85	64488481
Adjacent segment degeneration	18.44	16.04	3	10163	12	64488554
Hyperprolactinaemia	18.12	16.04	10	10156	4055	64484511
Kounis syndrome	17.92	16.04	9	10157	3016	64485550
Renal haematoma	17.91	16.04	6	10160	716	64487850
Cholelithiasis	17.33	16.04	28	10138	45478	64443088
Movement disorder	16.80	16.04	19	10147	21981	64466585
Hemianopia	16.78	16.04	7	10159	1532	64487034
Mass	16.72	16.04	16	10150	15260	64473306
Blood corticotrophin increased	16.58	16.04	4	10162	145	64488421
Arteriovenous fistula	16.57	16.04	6	10160	900	64487666
Infusion related reaction	16.48	16.04	3	10163	164464	64324102
Rheumatoid arthritis	16.46	16.04	3	10163	164291	64324275
Cardiac murmur	16.37	16.04	14	10152	11549	64477017
Carcinoid tumour	16.37	16.04	5	10161	443	64488123
Tumour compression	16.32	16.04	4	10162	155	64488411
Thyroid disorder	16.24	16.04	14	10152	11678	64476888

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	G02CB03	GENITO URINARY SYSTEM AND SEX HORMONES OTHER GYNECOLOGICALS OTHER GYNECOLOGICALS Prolactine inhibitors
ATC	N04BC06	NERVOUS SYSTEM ANTI-PARKINSON DRUGS DOPAMINERGIC AGENTS Dopamine agonists
FDA CS	M0007652	Ergolines
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:48407	antiparkinson agent
CHEBI has role	CHEBI:51065	Dopamine receptor agonist
MeSH PA	D018726	Anti-Dyskinesia Agents
MeSH PA	D000978	Antiparkinson Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D015259	Dopamine Agents
MeSH PA	D018491	Dopamine Agonists
MeSH PA	D018377	Neurotransmitter Agents
FDA EPC	N0000175827	Ergot Derivative

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

Disease	Relation	SNOMED_ID	DOID
Hyperprolactinemia	indication	237662005	DOID:12700
Heart valve disorder	contraindication	368009	DOID:4079
Severe pre-eclampsia	contraindication	46764007
Retroperitoneal fibrosis	contraindication	49120005
Fibrosis of lung	contraindication	51615001	DOID:3770
Fibrosis of pericardium	contraindication	194965002
Disease of liver	contraindication	235856003	DOID:409
Breastfeeding (mother)	contraindication	413712001
Hypertensive urgency	contraindication	443482000
Occlusive Vascular Disease	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.83	acidic
pKa2	13.48	acidic
pKa3	7.88	Basic
pKa4	5.97	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN	AGONIST	Ki	9.20	IUPHAR	CHEMBL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN	ANTAGONIST	Ki	7.90	IUPHAR
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN	AGONIST	Ki	7.70	IUPHAR
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN	AGONIST	Ki	8.20	IUPHAR
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	8.85	CHEMBL
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN	AGONIST	Ki	6.20	IUPHAR
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN	ANTAGONIST	Ki	6.50	IUPHAR
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN	ANTAGONIST	Ki	7.10	IUPHAR
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN	AGONIST	Ki	9.10	IUPHAR
D(1B) dopamine receptor	GPCR	P21918	DRD5_HUMAN	AGONIST	Ki	7.70	IUPHAR
5-hydroxytryptamine receptor 1B	GPCR	P28222	5HT1B_HUMAN	AGONIST	Ki	6.30	IUPHAR
5-hydroxytryptamine receptor 1D	GPCR	P28221	5HT1D_HUMAN	AGONIST	Ki	8.10	IUPHAR
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN	ANTAGONIST	Ki	7.70	IUPHAR
D(4) dopamine receptor	GPCR	P21917	DRD4_HUMAN	AGONIST	Ki	7.30	IUPHAR
Alpha-1D adrenergic receptor	GPCR	P25100	ADA1D_HUMAN		Ki	6.78	PDSP
D(1A) dopamine receptor	GPCR	P21728	DRD1_HUMAN	AGONIST	Ki	6.70	IUPHAR
Alpha-1B adrenergic receptor	GPCR	P35368	ADA1B_HUMAN		Ki	7.22	PDSP

External reference:

ID	Source
4021014	VUID
N0000148483	NUI
D00987	KEGG_DRUG
134895	RXNORM
C0107994	UMLSCUI
CHEBI:3286	CHEBI
CHEMBL1201087	ChEMBL_ID
D000077465	MESH_DESCRIPTOR_UI
DB00248	DRUGBANK_ID
37	IUPHAR_LIGAND_ID
5860	INN_ID
LL60K9J05T	UNII
54746	PUBCHEM_CID
4317	MMSL
6425	MMSL
73532	MMSL
d04112	MMSL
005446	NDDF
109139002	SNOMEDCT_US
386979007	SNOMEDCT_US
4021014	VANDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Cabergoline	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5420	TABLET	0.50 mg	ORAL	ANDA	25 sections
Cabergoline	HUMAN PRESCRIPTION DRUG LABEL	1	49884-673	TABLET	0.50 mg	ORAL	ANDA	21 sections
Cabergoline	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3157	TABLET	0.50 mg	ORAL	ANDA	25 sections
Cabergoline	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3951	TABLET	0.50 mg	ORAL	ANDA	21 sections
Cabergoline	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5834	TABLET	0.50 mg	ORAL	ANDA	22 sections
Cabergoline	HUMAN PRESCRIPTION DRUG LABEL	1	50742-118	TABLET	0.50 mg	ORAL	ANDA	23 sections
Cabergoline	HUMAN PRESCRIPTION DRUG LABEL	1	59762-1005	TABLET	0.50 mg	ORAL	NDA AUTHORIZED GENERIC	22 sections