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

Stem definition	Drug id	CAS RN
aromatic ring -CH(-OH)-CH2-NH-R	1531	36894-69-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: labetalol labetalol hydrochloride albetol ibidomide labetalol HCl SCH 19927 SCH-19927	A salicylamide derivative that is a non-cardioselective blocker of BETA-ADRENERGIC RECEPTORS and ALPHA-1 ADRENERGIC RECEPTORS. Molecular weight: 328.41 Formula: C19H24N2O3 CLOGP: 2.50 LIPINSKI: 0 HAC: 5 HDO: 4 TPSA: 95.58 ALOGS: -4.75 ROTB: 8 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

labetalol
labetalol hydrochloride
albetol
ibidomide
labetalol HCl
SCH 19927
SCH-19927

A salicylamide derivative that is a non-cardioselective blocker of BETA-ADRENERGIC RECEPTORS and ALPHA-1 ADRENERGIC RECEPTORS.

Molecular weight: 328.41
Formula: C19H24N2O3
CLOGP: 2.50
LIPINSKI: 0
HAC: 5
HDO: 4
TPSA: 95.58
ALOGS: -4.75
ROTB: 8

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.60	g	O
0.60	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	16 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	2.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	104.53 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	25 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	4.80 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	23 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.50 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	4.40 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Aug. 1, 1984	FDA	CNTY LINE PHARMS

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
Exposure during pregnancy	561.28	12.88	387	15472	124473	53208734
Premature delivery	475.17	12.88	205	15654	25899	53307308
Maternal exposure during pregnancy	421.80	12.88	357	15502	155282	53177925
Pre-eclampsia	375.28	12.88	128	15731	8519	53324688
Premature baby	206.63	12.88	106	15753	19695	53313512
Hypertension	193.17	12.88	283	15576	225148	53108059
Caesarean section	175.74	12.88	91	15768	17229	53315978
Low birth weight baby	167.18	12.88	65	15794	6272	53326935
Foetal exposure during pregnancy	153.86	12.88	107	15752	34608	53298599
Premature labour	84.27	12.88	50	15809	12312	53320895
Blood pressure inadequately controlled	80.88	12.88	36	15823	4875	53328332
Foetal growth restriction	73.62	12.88	38	15821	7136	53326071
Foetal death	66.84	12.88	39	15820	9308	53323899
Diabetes mellitus inadequate control	65.45	12.88	45	15814	14265	53318942
Oligohydramnios	61.82	12.88	32	15827	6044	53327163
Exomphalos	61.55	12.88	17	15842	552	53332655
Rheumatoid arthritis	61.37	12.88	10	15849	314521	53018686
Patent ductus arteriosus	60.89	12.88	28	15831	4090	53329117
HELLP syndrome	60.76	12.88	19	15840	957	53332250
Pregnancy	57.30	12.88	58	15801	31383	53301824
Phaeochromocytoma	56.83	12.88	16	15843	558	53332649
Multiple drug therapy	53.34	12.88	19	15840	1434	53331773
Proteinuria	51.86	12.88	43	15816	18025	53315182
Eclampsia	49.12	12.88	13	15846	358	53332849
Exercise tolerance decreased	45.72	12.88	25	15834	5270	53327937
Blood pressure increased	44.45	12.88	116	15743	140363	53192844
Haemangioma congenital	40.80	12.88	12	15847	490	53332717
Live birth	39.44	12.88	34	15825	15025	53318182
Normal newborn	38.67	12.88	25	15834	7154	53326053
Gestational diabetes	38.47	12.88	26	15833	8013	53325194
Abortion spontaneous	37.51	12.88	57	15802	46578	53286629
Hypotension	35.11	12.88	159	15700	253917	53079290
Gestational hypertension	34.92	12.88	16	15843	2317	53330890
Pulmonary oedema	34.13	12.88	59	15800	53664	53279543
Posterior reversible encephalopathy syndrome	33.51	12.88	32	15827	16128	53317079
Norepinephrine increased	33.09	12.88	7	15852	70	53333137
Drug intolerance	33.07	12.88	10	15849	205483	53127724
Frequent bowel movements	32.69	12.88	30	15829	14382	53318825
Hypertensive crisis	32.53	12.88	30	15829	14476	53318731
Foetal distress syndrome	32.39	12.88	13	15846	1362	53331845
BRASH syndrome	31.48	12.88	8	15851	187	53333020
Intestinal malrotation	29.89	12.88	9	15850	399	53332808
Hyperkalaemia	29.89	12.88	56	15803	54200	53279007
Endometritis	28.73	12.88	11	15848	1017	53332190
Cardiac failure congestive	28.70	12.88	76	15783	92681	53240526
Perinatal stroke	28.68	12.88	5	15854	15	53333192
Nipple pain	28.50	12.88	8	15851	276	53332931
Stillbirth	27.88	12.88	20	15839	6777	53326430
Cerebrovascular accident	27.45	12.88	81	15778	105093	53228114
Maternal drugs affecting foetus	26.69	12.88	18	15841	5528	53327679
Myocardial infarction	26.39	12.88	77	15782	99277	53233930
Hypermagnesaemia	25.41	12.88	10	15849	995	53332212
Cardiac arrest	25.27	12.88	73	15786	93594	53239613
Bradycardia	24.87	12.88	61	15798	70995	53262212
Arthropathy	24.41	12.88	6	15853	141447	53191760
Mental status changes	23.25	12.88	42	15817	39529	53293678
Neonatal respiratory distress syndrome	23.03	12.88	13	15846	2914	53330293
Hydrocephalus	22.85	12.88	16	15843	5220	53327987
Neuromuscular blockade	22.69	12.88	7	15852	337	53332870
Placental insufficiency	22.38	12.88	10	15849	1366	53331841
Induced labour	22.05	12.88	9	15850	984	53332223
Cerebral haemorrhage	21.80	12.88	35	15824	29961	53303246
Haemodynamic instability	21.69	12.88	19	15840	8575	53324632
Pain	21.52	12.88	96	15763	588302	52744905
Joint swelling	21.30	12.88	23	15836	234615	53098592
Contraindicated product administered	21.10	12.88	7	15852	135622	53197585
Phaeochromocytoma crisis	20.74	12.88	6	15853	231	53332976
Neonatal respiratory distress	20.38	12.88	6	15853	246	53332961
Glomerulonephritis rapidly progressive	20.13	12.88	8	15851	817	53332390
Angle closure glaucoma	20.07	12.88	11	15848	2329	53330878
Respiratory distress	19.99	12.88	36	15823	33791	53299416
Hypertrophic cardiomyopathy	18.90	12.88	9	15850	1422	53331785
Withdrawal hypertension	18.64	12.88	5	15854	145	53333062
Arthralgia	18.41	12.88	68	15791	439715	52893492
Sinusitis	18.30	12.88	14	15845	168550	53164657
Infusion related reaction	18.18	12.88	12	15847	155945	53177262
Medication error	18.14	12.88	36	15823	36329	53296878
Ultrasound uterus abnormal	17.81	12.88	4	15855	54	53333153
Small for dates baby	17.63	12.88	12	15847	3740	53329467
Haemorrhagic transformation stroke	17.25	12.88	8	15851	1190	53332017
Nephrogenic systemic fibrosis	17.23	12.88	13	15846	4754	53328453
Alopecia	17.17	12.88	27	15832	234556	53098651
Renal failure	16.97	12.88	75	15784	118377	53214830
Treatment noncompliance	16.84	12.88	33	15826	33002	53300205
Alveolar capillary dysplasia	16.54	12.88	3	15856	12	53333195
Haemorrhage intracranial	16.32	12.88	20	15839	13332	53319875
Kidney transplant rejection	16.30	12.88	12	15847	4232	53328975
Post transplant lymphoproliferative disorder	15.98	12.88	12	15847	4359	53328848
Pulseless electrical activity	15.91	12.88	15	15844	7439	53325768
Congenital intestinal malformation	15.83	12.88	3	15856	16	53333191
Gingival hypertrophy	15.49	12.88	8	15851	1503	53331704
Gastrointestinal disorder	15.17	12.88	4	15855	90000	53243207
Hypotonia neonatal	14.94	12.88	7	15852	1066	53332141
Malignant hypertension	14.74	12.88	7	15852	1099	53332108
Anti-neutrophil cytoplasmic antibody positive vasculitis	14.70	12.88	9	15850	2342	53330865
Autoimmune nephritis	14.51	12.88	5	15854	342	53332865
Decreased ventricular preload	14.46	12.88	3	15856	27	53333180
Thymus hypoplasia	14.37	12.88	3	15856	28	53333179
Apgar score low	14.31	12.88	6	15853	702	53332505
Glossodynia	14.21	12.88	6	15853	100285	53232922
Tongue oedema	14.03	12.88	11	15848	4256	53328951
Dilatation intrahepatic duct acquired	13.89	12.88	6	15853	756	53332451
Central nervous system lesion	13.70	12.88	16	15843	10146	53323061
Hepatitis acute	13.66	12.88	15	15844	8901	53324306
Oncologic complication	13.61	12.88	4	15855	163	53333044
Infection	13.39	12.88	19	15840	172186	53161021
Intraventricular haemorrhage	13.33	12.88	8	15851	2010	53331197

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
Foetal exposure during pregnancy	354.78	14.52	190	8933	41111	32463292
Premature baby	314.15	14.52	136	8987	18382	32486021
Low birth weight baby	237.66	14.52	85	9038	6909	32497494
Foetal growth restriction	79.66	14.52	33	9090	3979	32500424
Polydactyly	77.90	14.52	24	9099	1221	32503182
Foetal disorder	66.29	14.52	19	9104	751	32503652
Neutropenia neonatal	59.93	14.52	17	9106	647	32503756
Lichen planus	54.59	14.52	17	9106	896	32503507
Zoonotic bacterial infection	52.50	14.52	10	9113	59	32504344
Mycobacterium marinum infection	51.70	14.52	13	9110	309	32504094
Hypertension	48.31	14.52	111	9012	131639	32372764
Anhedonia	45.98	14.52	29	9094	8435	32495968
Maternal exposure during pregnancy	39.96	14.52	21	9102	4336	32500067
Choreoathetosis	36.52	14.52	13	9110	1038	32503365
Congenital oesophageal anomaly	36.50	14.52	8	9115	102	32504301
Neonatal respiratory distress	35.48	14.52	11	9112	571	32503832
Cardiac arrest	34.84	14.52	81	9042	96695	32407708
Apgar score low	33.92	14.52	12	9111	941	32503462
Injury	33.37	14.52	36	9087	22209	32482194
Neonatal hypoxia	31.56	14.52	9	9114	349	32504054
Fear	29.78	14.52	25	9098	11294	32493109
Patent ductus arteriosus	27.78	14.52	15	9108	3270	32501133
Hypotension	27.77	14.52	127	8996	215983	32288420
Mental status changes	27.40	14.52	43	9080	38294	32466109
Newborn persistent pulmonary hypertension	26.66	14.52	6	9117	87	32504316
Nephrogenic systemic fibrosis	26.40	14.52	16	9107	4336	32500067
Chronic kidney disease	26.06	14.52	43	9080	39932	32464471
Polyhydramnios	25.08	14.52	7	9116	251	32504152
Hydrops foetalis	24.76	14.52	7	9116	263	32504140
Bradycardia	24.76	14.52	59	9064	71503	32432900
Renal injury	24.49	14.52	23	9100	12032	32492371
Emotional distress	23.77	14.52	26	9097	16280	32488123
Cardiac failure congestive	23.18	14.52	64	9059	84788	32419615
Bradycardia foetal	22.77	14.52	7	9116	353	32504050
Cleft lip and palate	22.53	14.52	7	9116	366	32504037
Maternal drugs affecting foetus	21.60	14.52	14	9109	4263	32500140
Malignant hypertension	21.59	14.52	8	9115	716	32503687
Familial periodic paralysis	20.94	14.52	5	9118	95	32504308
Posterior reversible encephalopathy syndrome	20.87	14.52	19	9104	9557	32494846
Trisomy 18	20.79	14.52	6	9117	243	32504160
Pyelocaliectasis	20.27	14.52	9	9114	1283	32503120
Hypertensive crisis	20.21	14.52	18	9105	8799	32495604
Haemorrhagic transformation stroke	19.84	14.52	9	9114	1349	32503054
Cerebrovascular accident	19.64	14.52	61	9062	86259	32418144
Bronchopulmonary dysplasia	19.58	14.52	7	9116	566	32503837
Complications of transplanted kidney	19.15	14.52	13	9110	4277	32500126
Renal transplant failure	18.26	14.52	8	9115	1106	32503297
Neonatal cholestasis	18.04	14.52	4	9119	54	32504349
Trigemino-cardiac reflex	17.68	14.52	5	9118	188	32504215
Exposure during pregnancy	17.59	14.52	17	9106	9212	32495191
Rickets	17.40	14.52	4	9119	64	32504339
Zoonosis	16.17	14.52	3	9120	15	32504388
Foetal death	16.06	14.52	5	9118	263	32504140
Cardiomyopathy	15.89	14.52	21	9102	15992	32488411
Ventricular septal defect	15.86	14.52	11	9112	3746	32500657
Skin fibrosis	15.32	14.52	7	9116	1067	32503336
Blood pressure increased	15.28	14.52	53	9070	79301	32425102
Gastrointestinal tract mucosal pigmentation	14.53	14.52	5	9118	361	32504042

Pharmacologic Action:

Source	Code	Description
ATC	C07AG01	CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS Alpha and beta blocking agents
ATC	C07BG01	CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS AND THIAZIDES Alpha and beta blocking agents and thiazides
ATC	C07CG01	CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS AND OTHER DIURETICS Alpha and beta blocking agents and other diuretics
FDA MoA	N0000000161	Adrenergic beta-Antagonists
FDA EPC	N0000175556	beta-Adrenergic Blocker
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D058668	Adrenergic alpha-1 Receptor Antagonists
MeSH PA	D000317	Adrenergic alpha-Antagonists
MeSH PA	D018674	Adrenergic Antagonists
MeSH PA	D000319	Adrenergic beta-Antagonists
MeSH PA	D000959	Antihypertensive Agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D013566	Sympathomimetics
CHEBI has role	CHEBI:35530	beta-adrenoceptor antagonists
CHEBI has role	CHEBI:35674	antihypertensive
CHEBI has role	CHEBI:37890	alpha-adrenoceptor antagonists
CHEBI has role	CHEBI:66991	sympatholytics

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Hypertensive disorder	indication	38341003	DOID:10763
Angina pectoris	off-label use	194828000
Pheochromocytoma Adjunct Therapy	off-label use
Anuria	contraindication	2472002	DOID:2983
Bronchospasm	contraindication	4386001
Hypercholesterolemia	contraindication	13644009
Secondary angle-closure glaucoma	contraindication	21571006
Complete atrioventricular block	contraindication	27885002
Hypovolemia	contraindication	28560003
Dehydration	contraindication	34095006
Depressive disorder	contraindication	35489007
Hyperuricemia	contraindication	35885006	DOID:1920
Hypokalemia	contraindication	43339004
Low blood pressure	contraindication	45007003
Sinus bradycardia	contraindication	49710005
Systemic lupus erythematosus	contraindication	55464009	DOID:9074
Sympathectomy	contraindication	57071006
Hepatic failure	contraindication	59927004
Hypercalcemia	contraindication	66931009	DOID:12678
Hyperparathyroidism	contraindication	66999008	DOID:13543
Hypochloremic alkalosis	contraindication	70134007
Hepatic coma	contraindication	72836002	DOID:12550
Diabetes mellitus	contraindication	73211009	DOID:9351
Pulmonary emphysema	contraindication	87433001
Cardiogenic shock	contraindication	89138009
Hyponatremia	contraindication	89627008
Gout	contraindication	90560007	DOID:13189
Kidney disease	contraindication	90708001	DOID:557
Hypomagnesemia	contraindication	190855004
Partial atrioventricular block	contraindication	195039008
Decompensated cardiac failure	contraindication	195111005
Acute pancreatitis	contraindication	197456007	DOID:2913
Disease of liver	contraindication	235856003	DOID:409
Neonatal hyperbilirubinemia	contraindication	281610001
Intraoperative floppy iris syndrome	contraindication	418801006
Azotemia	contraindication	445009001

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.81	acidic
pKa2	12.65	acidic
pKa3	8.23	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
Beta-1 adrenergic receptor	GPCR	P08588	ADRB1_HUMAN	ANTAGONIST	Ki	8.23	DRUG MATRIX	CHEMBL
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN	ANTAGONIST	Ki	7.96	DRUG MATRIX	CHEMBL
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	6.12	DRUG MATRIX
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	5.48	DRUG MATRIX
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Ki	6.65	DRUG MATRIX
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	5.71	DRUG MATRIX
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Ki	5.89	DRUG MATRIX
Cytochrome P450 2D6	Enzyme	P10635	CP2D6_HUMAN		IC50	6.10	DRUG MATRIX
Alpha-1D adrenergic receptor	GPCR	P25100	ADA1D_HUMAN	ANTAGONIST	Ki	7.64	DRUG MATRIX
Alpha-1B adrenergic receptor	GPCR		ADA1B_RAT		Ki	6.49	DRUG MATRIX
Alpha-1A adrenergic receptor	GPCR		ADA1A_RAT		IC50	7.24	CHEMBL
5-hydroxytryptamine receptor 1A	GPCR		5HT1A_RAT		IC50	6.41	CHEMBL
CAAX prenyl protease 1	Enzyme		STE24_YEAST		AC50	5.11	CHEMBL
CAAX prenyl protease 2	Enzyme		RCE1_YEAST		AC50	4.82	CHEMBL

External reference:

ID	Source
4019797	VUID
N0000147886	NUI
D00600	KEGG_DRUG
32780-64-6	SECONDARY_CAS_RN
4018799	VANDF
4019797	VANDF
C0022860	UMLSCUI
CHEBI:6343	CHEBI
CHEMBL429	ChEMBL_ID
CHEMBL1200323	ChEMBL_ID
DB00598	DRUGBANK_ID
D007741	MESH_DESCRIPTOR_UI
3869	PUBCHEM_CID
7207	IUPHAR_LIGAND_ID
3941	INN_ID
R5H8897N95	UNII
202693	RXNORM
11828	MMSL
201477	MMSL
4950	MMSL
d00016	MMSL
001839	NDDF
004368	NDDF
372750000	SNOMEDCT_US
46547007	SNOMEDCT_US
50627005	SNOMEDCT_US
CHEMBL1204165	ChEMBL_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Labetalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9320	INJECTION	5 mg	INTRAVENOUS	ANDA	24 sections
Labetalol HCl in Sodium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9363	INJECTION	1 mg	INTRAVENOUS	NDA	23 sections
Labetalol HCl in Sodium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9364	INJECTION	1 mg	INTRAVENOUS	NDA	23 sections
Labetalol HCl in Sodium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9365	INJECTION	1 mg	INTRAVENOUS	NDA	23 sections
Labetalol HCl in Dextrose	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9366	INJECTION	1 mg	INTRAVENOUS	NDA	23 sections
Labetalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9622	INJECTION	5 mg	INTRAVENOUS	ANDA	23 sections
Labetalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9623	INJECTION	5 mg	INTRAVENOUS	ANDA	23 sections
Labetalol HCl	HUMAN PRESCRIPTION DRUG LABEL	1	0185-0010	TABLET, FILM COATED	100 mg	ORAL	ANDA	23 sections
Labetalol HCl	HUMAN PRESCRIPTION DRUG LABEL	1	0185-0117	TABLET, FILM COATED	200 mg	ORAL	ANDA	23 sections
Labetalol HCl	HUMAN PRESCRIPTION DRUG LABEL	1	0185-0118	TABLET, FILM COATED	300 mg	ORAL	ANDA	23 sections
Labetalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2267	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	12 sections
Labetalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2339	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	12 sections
Labetalol hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-0605	TABLET, FILM COATED	100 mg	ORAL	ANDA	22 sections
Labetalol hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-0606	TABLET, FILM COATED	200 mg	ORAL	ANDA	22 sections
Labetalol hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-0607	TABLET, FILM COATED	300 mg	ORAL	ANDA	22 sections
Labetalol HCL	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8130	TABLET, FILM COATED	100 mg	ORAL	ANDA	22 sections
Labetalol HCL	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8131	TABLET, FILM COATED	200 mg	ORAL	ANDA	22 sections
Labetalol hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-5928	TABLET, FILM COATED	100 mg	ORAL	ANDA	22 sections
Labetalol hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-5929	TABLET, FILM COATED	200 mg	ORAL	ANDA	22 sections
Labetalol hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-5930	TABLET, FILM COATED	300 mg	ORAL	ANDA	22 sections
Labetalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7109	TABLET, FILM COATED	100 mg	ORAL	ANDA	19 sections
Labetalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7110	TABLET, FILM COATED	200 mg	ORAL	ANDA	19 sections
Labetalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7111	TABLET, FILM COATED	300 mg	ORAL	ANDA	19 sections
Labetalol	HUMAN PRESCRIPTION DRUG LABEL	1	10135-641	TABLET, FILM COATED	100 mg	ORAL	ANDA	23 sections
Labetalol	HUMAN PRESCRIPTION DRUG LABEL	1	10135-642	TABLET, FILM COATED	200 mg	ORAL	ANDA	23 sections
Labetalol	HUMAN PRESCRIPTION DRUG LABEL	1	10135-643	TABLET, FILM COATED	300 mg	ORAL	ANDA	23 sections
Labetalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	10135-711	TABLET, FILM COATED	100 mg	ORAL	ANDA	24 sections
Labetalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	10135-712	TABLET, FILM COATED	200 mg	ORAL	ANDA	24 sections
Labetalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	10135-713	TABLET, FILM COATED	300 mg	ORAL	ANDA	24 sections
LABETALOL HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-994	TABLET, FILM COATED	300 mg	ORAL	ANDA	24 sections