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

Stem definitionDrug idCAS RN
aromatic ring -CH(-OH)-CH2-NH-R 1531 36894-69-6

Description:

MoleculeDescription

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:

DoseUnitRoute
0.60 g O
0.60 g P

ADMET properties:

PropertyValueReference
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 ┬ÁM/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:

DateAgencyCompanyOrphan
Aug. 1, 1984 FDA CNTY LINE PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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)

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Beta-1 adrenergic receptor GPCR ANTAGONIST Ki 8.23 DRUG MATRIX CHEMBL
Beta-2 adrenergic receptor GPCR ANTAGONIST Ki 7.96 DRUG MATRIX CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 6.12 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 5.48 DRUG MATRIX
5-hydroxytryptamine receptor 1A GPCR Ki 6.65 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 5.71 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.89 DRUG MATRIX
Cytochrome P450 2D6 Enzyme IC50 6.10 DRUG MATRIX
Alpha-1D adrenergic receptor GPCR ANTAGONIST Ki 7.64 DRUG MATRIX
Alpha-1B adrenergic receptor GPCR Ki 6.49 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR IC50 7.24 CHEMBL
5-hydroxytryptamine receptor 1A GPCR IC50 6.41 CHEMBL
CAAX prenyl protease 1 Enzyme AC50 5.11 CHEMBL
CAAX prenyl protease 2 Enzyme AC50 4.82 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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