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

Stem definition	Drug id	CAS RN
antihypertensives, hydrazinephthalazine derivatives	1384	86-54-4

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.10	g	O

ADMET properties:

Property	Value	Reference
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 µM/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:

Date	Agency	Company	Orphan
Jan. 15, 1953	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
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 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
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:

Source	Code	Description
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)

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Ryanodine receptor 2	Ion channel	Q92736	RYR2_HUMAN	BLOCKER			SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
DNA (cytosine-5)-methyltransferase 3B	Enzyme	Q9UBC3	DNM3B_HUMAN				WOMBAT-PK
DNA (cytosine-5)-methyltransferase 3A	Enzyme	Q9Y6K1	DNM3A_HUMAN				WOMBAT-PK
DNA (cytosine-5)-methyltransferase 1	Enzyme	P26358	DNMT1_HUMAN				WOMBAT-PK
Voltage-dependent L-type calcium channel subunit alpha-1C	Ion channel	Q13936	CAC1C_HUMAN				WOMBAT-PK
Aldehyde oxidase	Enzyme	Q06278	AOXA_HUMAN				WOMBAT-PK
Ryanodine receptor 2	Ion channel		RYR2_RAT		IC50	7.15	SCIENTIFIC LITERATURE
Cholinesterase	Enzyme		CHLE_HORSE		Ki	5.72	CHEMBL
Acetylcholinesterase	Enzyme		ACES_ELEEL		Ki	5.15	CHEMBL
Arachidonate 15-lipoxygenase	Enzyme		LOX15_RABIT		IC50	5.44	DRUG MATRIX

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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