Quinapril
Quinapril Tablets, USP
Approved
Approval ID
976577fd-f9dc-4c41-8051-9dd7f949fc87
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2010
Manufacturers
FDA
Sun Pharmaceutical Industries Limited
DUNS: 650172430
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 Code62756-313
Application NumberANDA090800
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2009
FDA Product Classification
INGREDIENTS (11)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 33067B3N2M
Classification: ACTIB
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-310
Application NumberANDA090800
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2009
FDA Product Classification
INGREDIENTS (11)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 33067B3N2M
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-312
Application NumberANDA090800
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2009
FDA Product Classification
INGREDIENTS (11)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 33067B3N2M
Classification: ACTIB
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-311
Application NumberANDA090800
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2009
FDA Product Classification
INGREDIENTS (11)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 33067B3N2M
Classification: ACTIB
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT