Hydralazine Hydrochloride

Product NDC
71335-2307
11-digit product format
713352307
Labeler code
71335
Product ID
71335-2307_f30b02c3-4e14-4cbd-98d2-4d04e00c77f8
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
10 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
71335-2307-17133523070130 TABLET in 1 BOTTLE (71335-2307-1) 30 tablet2023-12-14NoNoHistorical
71335-2307-27133523070260 TABLET in 1 BOTTLE (71335-2307-2) 60 tablet2023-12-14NoNoHistorical
71335-2307-37133523070390 TABLET in 1 BOTTLE (71335-2307-3) 90 tablet2023-12-14NoNoHistorical
71335-2307-471335230704100 TABLET in 1 BOTTLE (71335-2307-4) 100 tablet2023-12-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HydrALAZINE Hydrochloride Tablets USPBryant Ranch Prepack2023-12-14HUMAN PRESCRIPTION DRUG LABEL100