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
e210f962-9b91-46c6-af8f-9f9a9ae84245
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 2
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 Code71205-172
Application NumberANDA204798
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olmesartan Medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2018
FDA Product Classification
INGREDIENTS (9)
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
OLMESARTAN MEDOXOMILActive
Quantity: 20 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Olmesartan Medoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71205-174
Application NumberANDA204798
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olmesartan Medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2018
FDA Product Classification
INGREDIENTS (9)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT