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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

d5658d8a-f8e9-454d-89a9-34884e753001

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 23, 2025

Manufacturers
FDA

Jubilant Cadista Pharmacuticals Inc.

DUNS: 118694141

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 Code59746-466
Application NumberANDA205482
Product Classification
M
Marketing Category
C73584
G
Generic Name
olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2025
FDA Product Classification

INGREDIENTS (9)

OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT

olmesartan medoxomil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59746-463
Application NumberANDA205482
Product Classification
M
Marketing Category
C73584
G
Generic Name
olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2025
FDA Product Classification

INGREDIENTS (10)

OLMESARTAN MEDOXOMILActive
Quantity: 5 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT

olmesartan medoxomil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59746-465
Application NumberANDA205482
Product Classification
M
Marketing Category
C73584
G
Generic Name
olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2025
FDA Product Classification

INGREDIENTS (9)

OLMESARTAN MEDOXOMILActive
Quantity: 20 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT

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olmesartan medoxomil - FDA Drug Approval Details