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FDA Approval

benazepril hydrochloride and hydrochlorothiazide

CompanyPadagis US LLC (DUNS: 967694121)

Effective Date

May 11, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrochlorothiazide(25 mg in 1 1)

Benazepril(20 mg in 1 1)

Products (3)

benazepril hydrochloride and hydrochlorothiazide

NDC Product Code

0574-0228

Application Number

NDA020033

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

May 11, 2023

Ingredients

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 25 mg in 1 1

BenazeprilActive

Code: N1SN99T69TClass: ACTIBQuantity: 20 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEYClass: IACT

benazepril hydrochloride and hydrochlorothiazide

NDC Product Code

0574-0227

Application Number

NDA020033

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

May 11, 2023

Ingredients

BenazeprilActive

Code: N1SN99T69TClass: ACTIBQuantity: 10 mg in 1 1

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEYClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

benazepril hydrochloride and hydrochlorothiazide

NDC Product Code

0574-0229

Application Number

NDA020033

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

May 11, 2023

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEYClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

BenazeprilActive

Code: N1SN99T69TClass: ACTIBQuantity: 20 mg in 1 1

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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