Quinapril
Quinapril Tablets, USPRx Only
Approved
Approval ID
e6d36e1e-8e35-4d06-83dc-45e0456365fd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2023
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
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 Code69097-843
Application NumberANDA078457
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2019
FDA Product Classification
INGREDIENTS (10)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
QUINAPRIL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-842
Application NumberANDA078457
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2019
FDA Product Classification
INGREDIENTS (10)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-839
Application NumberANDA078457
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2019
FDA Product Classification
INGREDIENTS (10)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-841
Application NumberANDA078457
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2019
FDA Product Classification
INGREDIENTS (10)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT