Accupril
Accupril (quinapril) Tablets
Approved
Approval ID
63cf5651-d52c-4d27-9fd4-ed9cd9724dff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2023
Manufacturers
FDA
Parke-Davis Div of Pfizer Inc
DUNS: 829076962
Products 8
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
quinapril hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0071-0532
Application NumberNDA019885
Product Classification
M
Marketing Category
C73594
G
Generic Name
quinapril hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2022
FDA Product Classification
INGREDIENTS (9)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
QUINAPRIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
quinapril hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0071-0535
Application NumberNDA019885
Product Classification
M
Marketing Category
C73594
G
Generic Name
quinapril hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2022
FDA Product Classification
INGREDIENTS (9)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0071-1410
Application NumberNDA019885
Product Classification
M
Marketing Category
C73594
G
Generic Name
quinapril
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2022
FDA Product Classification
INGREDIENTS (9)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
quinapril hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0071-0527
Application NumberNDA019885
Product Classification
M
Marketing Category
C73594
G
Generic Name
quinapril hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2022
FDA Product Classification
INGREDIENTS (9)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0071-1840
Application NumberNDA019885
Product Classification
M
Marketing Category
C73594
G
Generic Name
quinapril
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2022
FDA Product Classification
INGREDIENTS (9)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
quinapril hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0071-0530
Application NumberNDA019885
Product Classification
M
Marketing Category
C73594
G
Generic Name
quinapril hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2022
FDA Product Classification
INGREDIENTS (9)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0071-1620
Application NumberNDA019885
Product Classification
M
Marketing Category
C73594
G
Generic Name
quinapril
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2022
FDA Product Classification
INGREDIENTS (9)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
quinapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0071-1205
Application NumberNDA019885
Product Classification
M
Marketing Category
C73594
G
Generic Name
quinapril
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2022
FDA Product Classification
INGREDIENTS (9)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 11/21/2022
PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Label
Pfizer
NDC 0071-1840-23
Accupril®
(quinapril) tablets
40 mg*
90 Tablets
Rx only
