Hydralazine Hydrochloride
Hydralazine Hydrochloride Injection, USP Preservative Free Rx only
Approved
Approval ID
f0db9c3c-d841-46f9-8409-9ffca83d7a97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 27, 2025
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydralazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1988
Application NumberANDA202938
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydralazine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 27, 2025
FDA Product Classification
INGREDIENTS (5)
HYDRALAZINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: FD171B778Y
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT