Hydralazine Hydrochloride

Product NDC
71335-2352
11-digit product format
713352352
Labeler code
71335
Product ID
71335-2352_c500c938-29f9-44a4-ade1-6915016fc952
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205236
Marketing category
ANDA
Marketing start
2017-05-26
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
25 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
71335-2352-17133523520130 TABLET in 1 BOTTLE (71335-2352-1) 30 tablet2024-02-21NoNoHistorical
71335-2352-27133523520260 TABLET in 1 BOTTLE (71335-2352-2) 60 tablet2024-02-21NoNoHistorical
71335-2352-37133523520390 TABLET in 1 BOTTLE (71335-2352-3) 90 tablet2024-02-21NoNoHistorical
71335-2352-47133523520410 TABLET in 1 BOTTLE (71335-2352-4) 10 tablet2024-02-21NoNoHistorical
71335-2352-571335235205100 TABLET in 1 BOTTLE (71335-2352-5) 100 tablet2024-02-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HydrALAZINE Hydrochloride Tablets USPBryant Ranch Prepack2024-12-03HUMAN PRESCRIPTION DRUG LABEL101