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olmesartan medoxomil

These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2002

Approved
Approval ID

e5dbca00-4e1b-4479-b829-021b11bc021e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 15, 2023

Manufacturers
FDA

Accord Healthcare Inc.

DUNS: 604222237

Products 3

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

olmesartan medoxomil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16729-320
Application NumberANDA207662
Product Classification
M
Marketing Category
C73584
G
Generic Name
olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification

INGREDIENTS (10)

HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
OLMESARTAN MEDOXOMILActive
Quantity: 5 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

olmesartan medoxomil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16729-321
Application NumberANDA207662
Product Classification
M
Marketing Category
C73584
G
Generic Name
olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification

INGREDIENTS (9)

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
OLMESARTAN MEDOXOMILActive
Quantity: 20 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB

olmesartan medoxomil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16729-322
Application NumberANDA207662
Product Classification
M
Marketing Category
C73584
G
Generic Name
olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification

INGREDIENTS (9)

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

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olmesartan medoxomil - FDA Drug Approval Details