MedPath

Quinapril

Quinapril Tablets USP

Approved
Approval ID

a6cf2ffd-cf94-4f1c-a12e-ce0e93a6304d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 14, 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.

Quinapril

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71335-1707
Application NumberANDA077690
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2021
FDA Product Classification

INGREDIENTS (12)

FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
QUINAPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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Quinapril - FDA Drug Approval Details