quinapril hydrochloride and hydrochlorothiazide

Quinapril and hydrochlorothiazide Tablets

Approved

Approval ID

a4985462-793f-45ab-bbee-43bc9d1135ce

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 8, 2021

Manufacturers

FDA

Greenstone LLC

DUNS: 825560733

Products 6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

quinapril hydrochloride and hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59762-0222

Application NumberNDA020125

Product Classification

Marketing Category

C73605

Generic Name

quinapril hydrochloride and hydrochlorothiazide

Product Specifications

Route of AdministrationORAL

Effective DateNovember 8, 2021

FDA Product Classification

INGREDIENTS (14)

QUINAPRIL HYDROCHLORIDEActive

Quantity: 10 mg in 1 1

Code: 33067B3N2M

Classification: ACTIR

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MK

Classification: IACT

HYDROCHLOROTHIAZIDEActive

Quantity: 12.5 mg in 1 1

Code: 0J48LPH2TH

Classification: ACTIB

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NA

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

CANDELILLA WAXInactive

Code: WL0328HX19

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

quinapril and hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59762-1112

Application NumberNDA020125

Product Classification

Marketing Category

C73605

Generic Name

quinapril and hydrochlorothiazide

Product Specifications

Route of AdministrationORAL

Effective DateNovember 8, 2021

FDA Product Classification

INGREDIENTS (14)

QUINAPRIL HYDROCHLORIDEActive

Quantity: 10 mg in 1 1

Code: 33067B3N2M

Classification: ACTIR

HYDROCHLOROTHIAZIDEActive

Quantity: 12.5 mg in 1 1

Code: 0J48LPH2TH

Classification: ACTIB

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MK

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NA

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CANDELILLA WAXInactive

Code: WL0328HX19

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

quinapril hydrochloride and hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59762-0223

Application NumberNDA020125

Product Classification

Marketing Category

C73605

Generic Name

quinapril hydrochloride and hydrochlorothiazide

Product Specifications

Route of AdministrationORAL

Effective DateNovember 8, 2021

FDA Product Classification

INGREDIENTS (14)

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MK

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

HYDROCHLOROTHIAZIDEActive

Quantity: 25 mg in 1 1

Code: 0J48LPH2TH

Classification: ACTIB

CANDELILLA WAXInactive

Code: WL0328HX19

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

QUINAPRIL HYDROCHLORIDEActive

Quantity: 20 mg in 1 1

Code: 33067B3N2M

Classification: ACTIR

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NA

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

quinapril and hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59762-3212

Application NumberNDA020125

Product Classification

Marketing Category

C73605

Generic Name

quinapril and hydrochlorothiazide

Product Specifications

Route of AdministrationORAL

Effective DateNovember 8, 2021

FDA Product Classification

INGREDIENTS (14)

HYDROCHLOROTHIAZIDEActive

Quantity: 12.5 mg in 1 1

Code: 0J48LPH2TH

Classification: ACTIB

CANDELILLA WAXInactive

Code: WL0328HX19

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

QUINAPRIL HYDROCHLORIDEActive

Quantity: 20 mg in 1 1

Code: 33067B3N2M

Classification: ACTIR

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MK

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NA

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

quinapril hydrochloride and hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59762-0220

Application NumberNDA020125

Product Classification

Marketing Category

C73605

Generic Name

quinapril hydrochloride and hydrochlorothiazide

Product Specifications

Route of AdministrationORAL

Effective DateNovember 8, 2021

FDA Product Classification

INGREDIENTS (14)

QUINAPRIL HYDROCHLORIDEActive

Quantity: 20 mg in 1 1

Code: 33067B3N2M

Classification: ACTIR

HYDROCHLOROTHIAZIDEActive

Quantity: 12.5 mg in 1 1

Code: 0J48LPH2TH

Classification: ACTIB

CANDELILLA WAXInactive

Code: WL0328HX19

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MK

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NA

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

quinapril and hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59762-5225

Application NumberNDA020125

Product Classification

Marketing Category

C73605

Generic Name

quinapril and hydrochlorothiazide

Product Specifications

Route of AdministrationORAL

Effective DateNovember 8, 2021

FDA Product Classification

INGREDIENTS (14)

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

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

MAGNESIUM CARBONATEInactive

Code: 0E53J927NA

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

HYDROCHLOROTHIAZIDEActive

Quantity: 25 mg in 1 1

Code: 0J48LPH2TH

Classification: ACTIB

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

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quinapril hydrochloride and hydrochlorothiazide

Products 6

quinapril hydrochloride and hydrochlorothiazide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

quinapril and hydrochlorothiazide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

quinapril hydrochloride and hydrochlorothiazide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

quinapril and hydrochlorothiazide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

quinapril hydrochloride and hydrochlorothiazide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

quinapril and hydrochlorothiazide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

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