Hydralazine Hydrochloride

Product NDC
33342-377
11-digit product format
333420377
Labeler code
33342
Product ID
33342-377_f9f56326-6d72-47d3-89ac-3625b8a6d713
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA211010
Marketing category
ANDA
Marketing start
2024-08-26
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
33342-377-1133342037711100 TABLET in 1 BOTTLE (33342-377-11) 100 tablet2024-08-26NoNoHistorical
33342-377-123334203771210 BLISTER PACK in 1 CARTON (33342-377-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2024-08-26NoNoHistorical
33342-377-44333420377441000 TABLET in 1 BOTTLE (33342-377-44) 1000 tablet2024-08-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydralazine Hydrochloride Tablets, USP Prescribing InformationMacleods Pharmaceuticals Limited2024-09-06Human Prescription Drug Label1