Quinapril
Quinapril Tablets, USP Rx only
Approved
Approval ID
3d4d30a9-b75e-491c-9e17-ca76bd082f1e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2015
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 4
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 Code31722-270
Application NumberANDA078457
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2015
FDA Product Classification
INGREDIENTS (10)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-269
Application NumberANDA078457
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2015
FDA Product Classification
INGREDIENTS (10)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
QUINAPRIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
Quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-268
Application NumberANDA078457
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2015
FDA Product Classification
INGREDIENTS (10)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-267
Application NumberANDA078457
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2015
FDA Product Classification
INGREDIENTS (10)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
QUINAPRIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT