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FDA Approval

olmesartan medoxomil-hydrochlorothiazide

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

DUNS: 796560394

Effective Date

August 16, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrochlorothiazide(25 mg in 1 1)

Olmesartan(40 mg in 1 1)

Products3

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

olmesartan medoxomil-hydrochlorothiazide

Product Details

NDC Product Code

42291-926

Application Number

NDA021532

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

August 16, 2023

Ingredients

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 2165RE0K14Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

HydrochlorothiazideActive

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

OlmesartanActive

Code: 6M97XTV3HDClass: ACTIBQuantity: 40 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

olmesartan medoxomil-hydrochlorothiazide

Product Details

NDC Product Code

42291-924

Application Number

NDA021532

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

August 16, 2023

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 2165RE0K14Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HydrochlorothiazideActive

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

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

OlmesartanActive

Code: 6M97XTV3HDClass: ACTIBQuantity: 20 mg in 1 1

olmesartan medoxomil-hydrochlorothiazide

Product Details

NDC Product Code

42291-925

Application Number

NDA021532

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

August 16, 2023

Ingredients

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 2165RE0K14Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

OlmesartanActive

Code: 6M97XTV3HDClass: ACTIBQuantity: 40 mg in 1 1

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

HydrochlorothiazideActive

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

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