Manufacturing Establishments (2)

Viatris Pharmaceuticals LLC

Labeler

Parke-Davis Div of Pfizer Inc

DUNS Number

829084552

Pfizer Inc

Labeler

Parke-Davis Div of Pfizer Inc

DUNS Number

943955690

Products (8)

Accupril

NDC Product Code

0071-0532

Application Number

NDA019885

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2022

Ingredients

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

Quinapril HydrochlorideActive

Code: 33067B3N2MClass: ACTIRQuantity: 20 mg in 1 1

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

Accupril

NDC Product Code

0071-0535

Application Number

NDA019885

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2022

Ingredients

Quinapril HydrochlorideActive

Code: 33067B3N2MClass: ACTIRQuantity: 40 mg in 1 1

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

Accupril

NDC Product Code

0071-1410

Application Number

NDA019885

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2022

Ingredients

Quinapril HydrochlorideActive

Code: 33067B3N2MClass: ACTIRQuantity: 10 mg in 1 1

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Accupril

NDC Product Code

0071-0527

Application Number

NDA019885

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2022

Ingredients

Quinapril HydrochlorideActive

Code: 33067B3N2MClass: ACTIRQuantity: 5 mg in 1 1

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Accupril

NDC Product Code

0071-1840

Application Number

NDA019885

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2022

Ingredients

Quinapril HydrochlorideActive

Code: 33067B3N2MClass: ACTIRQuantity: 40 mg in 1 1

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

Accupril

NDC Product Code

0071-0530

Application Number

NDA019885

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2022

Ingredients

Quinapril HydrochlorideActive

Code: 33067B3N2MClass: ACTIRQuantity: 10 mg in 1 1

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Accupril

NDC Product Code

0071-1620

Application Number

NDA019885

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2022

Ingredients

Quinapril HydrochlorideActive

Code: 33067B3N2MClass: ACTIRQuantity: 20 mg in 1 1

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

Accupril

NDC Product Code

0071-1205

Application Number

NDA019885

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2022

Ingredients

Quinapril HydrochlorideActive

Code: 33067B3N2MClass: ACTIRQuantity: 5 mg in 1 1

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

CANDELILLA WAXInactive

Code: WL0328HX19Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NAClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Label

Pfizer

NDC 0071-1840-23

Accupril®
(quinapril) tablets

40 mg*

90 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Label

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Premium Access

Accupril

Manufacturing Establishments (2)

Products (8)

Accupril

Accupril

Accupril

Accupril

Accupril

Accupril

Accupril

Accupril

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Label