Hydralazine Hydrochloride

Product NDC
55154-9587
11-digit product format
551549587
Labeler code
55154
Product ID
55154-9587_b7c211a9-fd05-46ae-87e8-10475663d9bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDRALAZINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA040388
Marketing category
ANDA
Marketing start
2024-10-31
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
20 mg/mL
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 formatDescriptionMarketing startSampleExclude flagStatus
55154-9587-5551549587055 VIAL, SINGLE-USE in 1 BAG (55154-9587-5) / 1 mL in 1 VIAL, SINGLE-USE2024-10-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydralazine Hydrochloride Injection, USPCardinal Health 107, LLC2025-10-13HUMAN PRESCRIPTION DRUG LABEL2
Hydralazine Hydrochloride Injection, USPCardinal Health 107, LLC2024-10-31HUMAN PRESCRIPTION DRUG LABEL1