Hydralazine Hydrochloride

Product NDC
63629-5246
11-digit product format
636295246
Labeler code
63629
Product ID
63629-5246_608758ea-f449-4ae7-895e-0c8c2b88cc38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040901
Marketing category
ANDA
Marketing start
2010-01-01
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
FD171B778YHYDRALAZINE HYDROCHLORIDE304-20-1HYDRALAZINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-5246-16362952460130 TABLET in 1 BOTTLE (63629-5246-1) 30 tablet2014-03-04NoNoHistorical
63629-5246-26362952460260 TABLET in 1 BOTTLE (63629-5246-2) 60 tablet2014-03-04NoNoHistorical
63629-5246-363629524603120 TABLET in 1 BOTTLE (63629-5246-3) 120 tablet2014-03-04NoNoHistorical
63629-5246-46362952460490 TABLET in 1 BOTTLE (63629-5246-4) 90 tablet2014-03-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HYDRALAZINE HYDROCHLORIDE TABLETS, USPBryant Ranch Prepack2025-03-25Human Prescription Drug Label1008