Quinapril
QUINAPRIL TABLETS USP5 mg, 10 mg, 20 mg and 40 mg
Approved
Approval ID
0a0aff51-3b61-4cde-a415-0694afec99eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
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 Code21695-393
Application NumberANDA077690
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 29, 2010
FDA Product Classification
INGREDIENTS (12)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
QUINAPRIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 33067B3N2M
Classification: ACTIM
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-394
Application NumberANDA077690
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 29, 2010
FDA Product Classification
INGREDIENTS (12)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
QUINAPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 33067B3N2M
Classification: ACTIM
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT