Hydralazine Hydrochloride

Product NDC
71335-9722
11-digit product format
713359722
Labeler code
71335
Product ID
71335-9722_58bc1add-d89b-4604-811f-3bc0534658aa
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
100 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
71335-9722-17133597220130 TABLET in 1 BOTTLE (71335-9722-1) 30 tablet2023-05-30NoNoHistorical
71335-9722-27133597220260 TABLET in 1 BOTTLE (71335-9722-2) 60 tablet2023-05-30NoNoHistorical
71335-9722-37133597220390 TABLET in 1 BOTTLE (71335-9722-3) 90 tablet2023-05-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HydrALAZINE Hydrochloride Tablets USPBryant Ranch Prepack2023-11-27HUMAN PRESCRIPTION DRUG LABEL101