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

Stem definitionDrug idCAS RN
antihypertensives, hydrazinephthalazine derivatives 1384 86-54-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • hydralazine
  • hydralazine hydrochloride
  • hydralazine HCl
A direct-acting vasodilator that is used as an antihypertensive agent.
  • Molecular weight: 160.18
  • Formula: C8H8N4
  • CLOGP: 1.17
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 63.83
  • ALOGS: -1.79
  • ROTB: 1

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.10 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 44.20 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 8 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 20.79 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 23 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 85 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.12 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 15, 1953 FDA

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
Anti-neutrophil cytoplasmic antibody positive vasculitis 1070.66 11.66 241 25157 1694 46658970
Glomerulonephritis rapidly progressive 368.50 11.66 84 25314 627 46660037
Pulmonary renal syndrome 295.66 11.66 63 25335 329 46660335
Cardiac failure congestive 294.62 11.66 303 25095 91447 46569217
Gastrointestinal tract mucosal pigmentation 224.07 11.66 54 25344 526 46660138
Glomerulonephritis 166.59 11.66 53 25345 1520 46659144
Lupus-like syndrome 153.02 11.66 78 25320 7766 46652898
Hypertension 138.82 11.66 320 25078 196036 46464628
Exposure during pregnancy 126.77 11.66 218 25180 107994 46552670
Acute kidney injury 115.65 11.66 335 25063 235520 46425144
Vasculitis 105.65 11.66 75 25323 13636 46647028
Rheumatoid arthritis 95.27 11.66 10 25388 240205 46420459
Renal vasculitis 90.84 11.66 22 25376 219 46660445
Pulmonary alveolar haemorrhage 88.85 11.66 44 25354 4118 46656546
Pre-eclampsia 83.92 11.66 53 25345 7941 46652723
Glomerulonephritis proliferative 80.58 11.66 19 25379 167 46660497
Chronic kidney disease 80.36 11.66 105 25293 40766 46619898
Blood pressure inadequately controlled 72.21 11.66 39 25359 4367 46656297
Premature delivery 69.05 11.66 72 25326 21997 46638667
Cerebrovascular accident 62.95 11.66 157 25241 100882 46559782
Lupus nephritis 57.81 11.66 27 25371 2219 46658445
Low birth weight baby 52.02 11.66 34 25364 5400 46655264
Hyperkalaemia 51.39 11.66 96 25302 50613 46610051
Pulmonary oedema 50.86 11.66 96 25302 51009 46609655
Fluid overload 50.59 11.66 68 25330 27117 46633547
End stage renal disease 49.55 11.66 34 25364 5852 46654812
Loss of employment 48.22 11.66 20 25378 1236 46659428
Renal failure 47.67 11.66 153 25245 113441 46547223
Antineutrophil cytoplasmic antibody positive 45.97 11.66 15 25383 467 46660197
Mental status changes 44.86 11.66 77 25321 38011 46622653
BRASH syndrome 41.62 11.66 10 25388 96 46660568
Premature baby 41.10 11.66 50 25348 18062 46642602
Premature labour 39.23 11.66 39 25359 11260 46649404
Alveolitis 37.74 11.66 21 25377 2492 46658172
Generalised oedema 36.39 11.66 42 25356 14357 46646307
Blood pressure increased 35.72 11.66 150 25248 126516 46534148
Dyspnoea 34.23 11.66 429 24969 515119 46145545
Norepinephrine increased 33.76 11.66 8 25390 72 46660592
Maternal exposure during pregnancy 33.36 11.66 127 25271 102422 46558242
Hospitalisation 30.89 11.66 90 25308 63295 46597369
Hypoxia 30.63 11.66 79 25319 51759 46608905
Blood glucose decreased 30.29 11.66 44 25354 18848 46641816
Peritonitis bacterial 30.28 11.66 30 25368 8623 46652041
Nephrogenic systemic fibrosis 29.78 11.66 23 25375 4749 46655915
Shock 29.53 11.66 47 25351 21798 46638866
Atrial fibrillation 29.45 11.66 123 25275 103467 46557197
Acute febrile neutrophilic dermatosis 28.67 11.66 18 25380 2667 46657997
Treatment failure 27.91 11.66 8 25390 93079 46567585
Respiratory failure 27.27 11.66 113 25285 94703 46565961
Gastrointestinal haemorrhage 26.97 11.66 98 25300 77275 46583389
Myocardial infarction 26.32 11.66 114 25284 97414 46563250
Diabetes mellitus inadequate control 26.03 11.66 34 25364 13180 46647484
Vasculitis necrotising 25.20 11.66 10 25388 551 46660113
Joint swelling 24.18 11.66 33 25365 166040 46494624
HELLP syndrome 23.43 11.66 11 25387 915 46659749
Alopecia 22.92 11.66 33 25365 162381 46498283
Oedema peripheral 22.88 11.66 157 25241 159549 46501115
Endometritis 22.84 11.66 11 25387 968 46659696
Eclampsia 22.53 11.66 8 25390 323 46660341
Off label use 22.12 11.66 119 25279 379722 46280942
Nodal rhythm 22.11 11.66 13 25385 1712 46658952
Drug abuse 21.90 11.66 4 25394 63404 46597260
Pulseless electrical activity 21.73 11.66 23 25375 7144 46653520
Orthopnoea 21.72 11.66 21 25377 5859 46654805
Pleural effusion 21.65 11.66 96 25302 82856 46577808
Neutropenia 21.30 11.66 28 25370 143176 46517488
Hypotension 21.06 11.66 206 25192 232383 46428281
Peripartum cardiomyopathy 20.85 11.66 6 25392 121 46660543
Multiple drug therapy 20.54 11.66 10 25388 901 46659763
Hypermagnesaemia 20.43 11.66 10 25388 912 46659752
Acute myocardial infarction 20.26 11.66 50 25348 31874 46628790
Caesarean section 20.11 11.66 34 25364 16569 46644095
Pyrexia 19.90 11.66 110 25288 348692 46311972
Pernicious anaemia 19.86 11.66 9 25389 690 46659974
Sinusitis 19.69 11.66 25 25373 129743 46530921
Drug ineffective 19.58 11.66 256 25142 677582 45983082
Hypoperfusion 19.16 11.66 11 25387 1386 46659278
Renal impairment 18.60 11.66 85 25313 74287 46586377
Bradycardia 18.27 11.66 78 25320 66220 46594444
Cutaneous vasculitis 18.13 11.66 16 25382 3975 46656689
Electrocardiogram QRS complex shortened 17.83 11.66 7 25391 375 46660289
Hyperplasia adrenal 17.77 11.66 4 25394 28 46660636
Haemolytic uraemic syndrome 17.64 11.66 13 25385 2501 46658163
Haemodynamic instability 16.99 11.66 21 25377 7704 46652960
Dialysis 16.86 11.66 24 25374 10092 46650572
Psoriasis 16.85 11.66 11 25387 78593 46582071
Injection site reaction 16.56 11.66 3 25395 47846 46612818
Stillbirth 16.51 11.66 19 25379 6472 46654192
Pain 16.49 11.66 173 25225 476775 46183889
Foetal death 16.46 11.66 22 25376 8721 46651943
Phaeochromocytoma 16.45 11.66 7 25391 461 46660203
Proteinuria 16.34 11.66 31 25367 16522 46644142
Blood creatinine increased 16.00 11.66 83 25315 76320 46584344
Autoantibody positive 15.99 11.66 4 25394 46 46660618
Musculoskeletal stiffness 15.79 11.66 18 25380 97975 46562689
Neonatal hyponatraemia 15.40 11.66 4 25394 54 46660610
Small for dates baby 15.38 11.66 14 25384 3623 46657041
Therapeutic product effect incomplete 15.36 11.66 12 25386 78141 46582523
Primary hyperaldosteronism 15.33 11.66 4 25394 55 46660609
Hypertensive emergency 15.18 11.66 10 25388 1608 46659056
Depression 15.14 11.66 45 25353 170059 46490605
Jugular vein distension 15.04 11.66 8 25390 868 46659796
Lupus pneumonitis 15.01 11.66 4 25394 60 46660604
Death 14.98 11.66 261 25137 335287 46325377
Inflammation 14.98 11.66 4 25394 48777 46611887
Suicidal ideation 14.90 11.66 6 25392 56376 46604288
Infusion related reaction 14.83 11.66 20 25378 101188 46559476
Cortisol increased 14.78 11.66 6 25392 351 46660313
Serositis 14.63 11.66 7 25391 607 46660057
Phaeochromocytoma crisis 14.55 11.66 5 25393 183 46660481
Abortion spontaneous 14.55 11.66 3 25395 43643 46617021
Exercise tolerance decreased 14.43 11.66 15 25383 4562 46656102
C3 glomerulopathy 14.18 11.66 3 25395 15 46660649
Dermatitis bullous 14.03 11.66 19 25379 7624 46653040
Injection site erythema 13.91 11.66 12 25386 74415 46586249
Skin induration 13.67 11.66 12 25386 2962 46657702
Hepatic steatosis 13.54 11.66 36 25362 24006 46636658
Left ventricular hypertrophy 13.43 11.66 15 25383 4948 46655716
Cardiac failure acute 13.22 11.66 19 25379 8059 46652605
Arthropathy 13.17 11.66 16 25382 84684 46575980
General physical health deterioration 13.14 11.66 27 25371 115742 46544922
Foetal growth restriction 13.10 11.66 17 25381 6550 46654114
Cardiac arrest 13.00 11.66 89 25309 90310 46570354
Glossodynia 12.96 11.66 4 25394 44369 46616295
Haemorrhagic transformation stroke 12.89 11.66 8 25390 1162 46659502
Pulmonary hypertension 12.88 11.66 46 25352 35947 46624717
C-reactive protein increased 12.83 11.66 8 25390 58582 46602082
Lower respiratory tract infection 12.80 11.66 7 25391 55082 46605582
Umbilical cord vascular disorder 12.66 11.66 4 25394 112 46660552
Bone marrow oedema 12.55 11.66 7 25391 834 46659830
Contusion 12.50 11.66 86 25312 87401 46573263
Synovitis 12.48 11.66 9 25389 61066 46599598
Respiratory distress 12.48 11.66 42 25356 31874 46628790
Bicuspid aortic valve 12.40 11.66 4 25394 120 46660544
Renal disorder 12.14 11.66 37 25361 26649 46634015
Kidney transplant rejection 12.10 11.66 13 25385 4105 46656559
Glomerulonephritis membranous 12.08 11.66 6 25392 565 46660099
Hypertensive urgency 11.92 11.66 4 25394 136 46660528
Sinus arrhythmia 11.79 11.66 8 25390 1352 46659312
Cardiomegaly 11.75 11.66 28 25370 17454 46643210
Lethargy 11.70 11.66 57 25341 51114 46609550
Pulmonary haemorrhage 11.68 11.66 16 25382 6489 46654175
Stag horn calculus 11.68 11.66 4 25394 145 46660519

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
Anti-neutrophil cytoplasmic antibody positive vasculitis 648.70 12.27 136 20397 487 29931458
Cardiac failure congestive 269.76 12.27 310 20223 84097 29847848
Glomerulonephritis rapidly progressive 226.26 12.27 54 20479 388 29931557
Lupus-like syndrome 194.79 12.27 68 20465 2061 29929884
Pulmonary renal syndrome 158.34 12.27 34 20499 140 29931805
Gastrointestinal tract mucosal pigmentation 126.12 12.27 30 20503 212 29931733
Chronic kidney disease 77.95 12.27 112 20421 37726 29894219
Acute kidney injury 75.90 12.27 379 20154 273463 29658482
Hypertension 67.11 12.27 209 20324 121145 29810800
Vasculitis 66.10 12.27 50 20483 7940 29924005
Device interaction 64.74 12.27 20 20513 408 29931537
Glomerulonephritis 57.38 12.27 27 20506 1786 29930159
Renal vasculitis 53.34 12.27 13 20520 103 29931842
Pulmonary alveolar haemorrhage 49.66 12.27 39 20494 6542 29925403
Lupus nephritis 46.50 12.27 14 20519 261 29931684
Systemic lupus erythematosus 45.90 12.27 26 20507 2530 29929415
End stage renal disease 45.49 12.27 39 20494 7396 29924549
Pulmonary oedema 43.15 12.27 94 20439 43881 29888064
Renal failure 38.03 12.27 182 20351 128784 29803161
Lupus vasculitis 37.72 12.27 6 20527 0 29931945
Mental status changes 37.22 12.27 80 20453 36999 29894946
Drug abuse 36.89 12.27 6 20527 82066 29849879
Hypotension 34.31 12.27 245 20288 200320 29731625
Myocardial infarction 33.98 12.27 173 20360 125452 29806493
Apgar score low 33.73 12.27 15 20518 870 29931075
Low birth weight baby 31.46 12.27 29 20504 6047 29925898
Premature baby 30.88 12.27 47 20486 16644 29915301
Drug ineffective 26.97 12.27 131 20402 340256 29591689
Histone antibody positive 25.62 12.27 5 20528 11 29931934
Unresponsive to stimuli 24.24 12.27 55 20478 26364 29905581
Human ehrlichiosis 24.14 12.27 8 20525 206 29931739
Lupus pneumonitis 24.04 12.27 6 20527 53 29931892
Cerebrovascular accident 23.28 12.27 116 20417 83361 29848584
Pyrexia 22.92 12.27 114 20419 294375 29637570
Proteinuria 22.48 12.27 40 20493 16105 29915840
Blood pressure increased 21.52 12.27 102 20431 71826 29860119
Troponin I increased 21.01 12.27 14 20519 1819 29930126
Anencephaly 19.63 12.27 6 20527 118 29931827
Pericardial effusion 19.37 12.27 44 20489 21100 29910845
Blood glucose decreased 19.03 12.27 33 20500 13020 29918925
Cardiomegaly 19.00 12.27 35 20498 14474 29917471
Blood creatinine increased 18.81 12.27 117 20416 91258 29840687
Tracheal injury 18.72 12.27 4 20529 16 29931929
Fluid overload 17.79 12.27 40 20493 19052 29912893
Renal injury 17.55 12.27 30 20503 11699 29920246
Peritonitis bacterial 16.89 12.27 29 20504 11349 29920596
Hepatic function abnormal 16.88 12.27 4 20529 41941 29890004
Hypocomplementaemia 16.27 12.27 4 20529 33 29931912
Glomerulonephritis proliferative 16.20 12.27 6 20527 216 29931729
Tubulointerstitial nephritis 16.14 12.27 37 20496 17854 29914091
C-reactive protein increased 15.89 12.27 5 20528 43468 29888477
Hyperparathyroidism secondary 15.88 12.27 10 20523 1180 29930765
General physical health deterioration 15.50 12.27 28 20505 99916 29832029
Cholestatic liver injury 15.45 12.27 11 20522 1590 29930355
Bradycardia foetal 15.30 12.27 6 20527 253 29931692
Neutropenia 15.05 12.27 42 20491 128498 29803447
Renal impairment 15.01 12.27 104 20429 84080 29847865
Hypertensive crisis 14.71 12.27 23 20510 8334 29923611
Rheumatoid arthritis 14.60 12.27 5 20528 41192 29890753
Rickets 14.55 12.27 4 20529 53 29931892
Interstitial lung disease 14.47 12.27 12 20521 60185 29871760
Asthenia 13.97 12.27 221 20312 221069 29710876
Hyperkalaemia 13.88 12.27 85 20448 65925 29866020
Nephrogenic systemic fibrosis 13.80 12.27 16 20517 4355 29927590
Dialysis 13.74 12.27 26 20507 10970 29920975
Acute febrile neutrophilic dermatosis 13.73 12.27 9 20524 1137 29930808
Full blood count decreased 13.62 12.27 32 20501 15685 29916260
Angioedema 13.54 12.27 53 20480 34331 29897614
Vasculitis necrotising 13.29 12.27 7 20526 590 29931355
Blood potassium increased 12.97 12.27 32 20501 16181 29915764
Renal failure neonatal 12.93 12.27 4 20529 82 29931863
Blood pressure inadequately controlled 12.79 12.27 12 20521 2558 29929387
Gout 12.62 12.27 33 20500 17282 29914663
Febrile neutropenia 12.38 12.27 35 20498 106658 29825287
Chest pain 12.31 12.27 129 20404 117498 29814447

Pharmacologic Action:

SourceCodeDescription
ATC C02DB02 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
ARTERIOLAR SMOOTH MUSCLE, AGENTS ACTING ON
Hydrazinophthalazine derivatives
ATC C02LG02 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
ANTIHYPERTENSIVES AND DIURETICS IN COMBINATION
Hydrazinophthalazine derivatives and diuretics
FDA PE N0000175379 Arteriolar Vasodilation
FDA EPC N0000175564 Arteriolar Vasodilator
CHEBI has role CHEBI:35620 vasodilator
CHEBI has role CHEBI:35674 antihypertensive
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D014665 Vasodilator Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Chronic heart failure indication 48447003
Anuria contraindication 2472002 DOID:2983
Suicidal thoughts contraindication 6471006
Peptic ulcer contraindication 13200003 DOID:750
Hypercholesterolemia contraindication 13644009
Chronic disease of respiratory system contraindication 17097001
Secondary angle-closure glaucoma contraindication 21571006
Myocardial infarction contraindication 22298006 DOID:5844
Electroconvulsive therapy contraindication 23835007
Hypovolemia contraindication 28560003
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Hyperuricemia contraindication 35885006 DOID:1920
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Ulcerative colitis contraindication 64766004 DOID:8577
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Benign intracranial hypertension contraindication 68267002 DOID:11459
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Injury of head contraindication 82271004
Epilepsy contraindication 84757009 DOID:1826
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Increased intestinal motility contraindication 102624003
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Cerebrovascular accident contraindication 230690007
Hypertrophic cardiomyopathy contraindication 233873004 DOID:11984
Lupus erythematosus and erythema multiforme-like syndrome contraindication 238926009
Calculus in biliary tract contraindication 266474003
Anemia contraindication 271737000 DOID:2355
Cerebral hemorrhage contraindication 274100004
Neonatal hyperbilirubinemia contraindication 281610001
Disorder of coronary artery contraindication 414024009
Myocardial infarction in recovery phase contraindication 418044006
Slow acetylator due to N-acetyltransferase enzyme variant contraindication 425079005
Azotemia contraindication 445009001
Malabsorption States contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 6.81 Basic
pKa2 3.26 Basic
pKa3 2.62 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
Ryanodine receptor 2 Ion channel BLOCKER SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
DNA (cytosine-5)-methyltransferase 3B Enzyme WOMBAT-PK
DNA (cytosine-5)-methyltransferase 3A Enzyme WOMBAT-PK
DNA (cytosine-5)-methyltransferase 1 Enzyme WOMBAT-PK
Voltage-dependent L-type calcium channel subunit alpha-1C Ion channel WOMBAT-PK
Aldehyde oxidase Enzyme WOMBAT-PK
Ryanodine receptor 2 Ion channel IC50 7.15 SCIENTIFIC LITERATURE
Cholinesterase Enzyme Ki 5.72 CHEMBL
Acetylcholinesterase Enzyme Ki 5.15 CHEMBL
Arachidonate 15-lipoxygenase Enzyme IC50 5.44 DRUG MATRIX

External reference:

IDSource
4019778 VUID
N0000147869 NUI
D01302 KEGG_DRUG
304-20-1 SECONDARY_CAS_RN
4017880 VANDF
4019778 VANDF
C0020223 UMLSCUI
CHEBI:5775 CHEBI
HLZ PDB_CHEM_ID
CHEMBL276832 ChEMBL_ID
CHEMBL542541 ChEMBL_ID
DB01275 DRUGBANK_ID
D006830 MESH_DESCRIPTOR_UI
7326 IUPHAR_LIGAND_ID
1 INN_ID
26NULLK24LS8 UNII
3637 PUBCHEM_CID
5470 RXNORM
4833 MMSL
896 MMSL
d00132 MMSL
000632 NDDF
004489 NDDF
22696000 SNOMEDCT_US
28662003 SNOMEDCT_US
387125005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0517-0901 INJECTION, SOLUTION 20 mg INTRAMUSCULAR ANDA 19 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7973 TABLET 100 mg ORAL ANDA 9 sections
HydrALAZINE hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-6231 INJECTION, SOLUTION 20 mg INTRAMUSCULAR ANDA 18 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6440 TABLET, FILM COATED 10 mg ORAL ANDA 8 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6441 TABLET, FILM COATED 25 mg ORAL ANDA 8 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6442 TABLET, FILM COATED 50 mg ORAL ANDA 8 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6443 TABLET, FILM COATED 100 mg ORAL ANDA 8 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 17478-934 INJECTION 20 mg INTRAVENOUS ANDA 19 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 21695-679 TABLET 10 mg ORAL ANDA 11 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 21695-680 TABLET 25 mg ORAL ANDA 11 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 21695-694 TABLET 50 mg ORAL ANDA 11 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 21695-695 TABLET 100 mg ORAL ANDA 11 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-001 TABLET, FILM COATED 10 mg ORAL ANDA 8 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-002 TABLET, FILM COATED 25 mg ORAL ANDA 8 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-003 TABLET, FILM COATED 50 mg ORAL ANDA 8 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-004 TABLET, FILM COATED 100 mg ORAL ANDA 8 sections
BiDil HUMAN PRESCRIPTION DRUG LABEL 2 24338-010 TABLET, FILM COATED 37.50 mg ORAL NDA 30 sections
Hydralazine Hydrochloride Human Prescription Drug Label 1 31722-519 TABLET 10 mg ORAL ANDA 19 sections
Hydralazine Hydrochloride Human Prescription Drug Label 1 31722-520 TABLET 25 mg ORAL ANDA 19 sections
Hydralazine Hydrochloride Human Prescription Drug Label 1 31722-521 TABLET 50 mg ORAL ANDA 19 sections
Hydralazine Hydrochloride Human Prescription Drug Label 1 31722-522 TABLET 100 mg ORAL ANDA 19 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 35356-943 TABLET 50 mg ORAL ANDA 20 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 39822-0500 INJECTION, SOLUTION 20 mg INTRAMUSCULAR ANDA 19 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 43063-392 TABLET, FILM COATED 50 mg ORAL ANDA 8 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43353-124 TABLET 100 mg ORAL ANDA 18 sections
HydrALAZINE Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43353-205 TABLET 100 mg ORAL ANDA 12 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43353-742 TABLET, FILM COATED 50 mg ORAL ANDA 20 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43353-756 TABLET, FILM COATED 25 mg ORAL ANDA 20 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43353-919 TABLET, FILM COATED 100 mg ORAL ANDA 20 sections
Hydralazine Hydrochloride Human Prescription Drug Label 1 50090-0137 TABLET 25 mg ORAL ANDA 19 sections