HYDRALAZINE HYDROCHLORIDE
Rx only
Approved
Approval ID
db138daf-2d2d-4730-a621-a1bd209d5b9f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2022
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-5696
Application NumberANDA086242
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydralazine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2021
FDA Product Classification
INGREDIENTS (10)
HYDRALAZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: FD171B778Y
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT