Edarbi
These HIGHLIGHTS do not include all the information needed to use EDARBI safely and effectively. See full prescribing information for EDARBI. Edarbi (azilsartan medoxomil) tablets, for oral use Initial U.S. Approval: 2011
Approved
Approval ID
52b27c75-9f5a-4816-bafd-dace9d7d2063
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2024
Manufacturers
FDA
Azurity Pharmaceuticals, Inc.
DUNS: 117505635
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Azilsartan kamedoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60631-040
Application NumberNDA200796
Product Classification
M
Marketing Category
C73594
G
Generic Name
Azilsartan kamedoxomil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 29, 2024
FDA Product Classification
INGREDIENTS (8)
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
Azilsartan kamedoxomilActive
Quantity: 40 mg in 1 1
Code: WEC6I2K1FC
Classification: ACTIR
fumaric acidInactive
Code: 88XHZ13131
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Azilsartan kamedoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60631-080
Application NumberNDA200796
Product Classification
M
Marketing Category
C73594
G
Generic Name
Azilsartan kamedoxomil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 29, 2024
FDA Product Classification
INGREDIENTS (8)
Azilsartan kamedoxomilActive
Quantity: 80 mg in 1 1
Code: WEC6I2K1FC
Classification: ACTIR
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
fumaric acidInactive
Code: 88XHZ13131
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT