Edarbyclor
These highlights do not include all the information needed to use EDARBYCLOR safely and effectively. See full prescribing information for EDARBYCLOR. EDARBYCLOR (azilsartan medoxomil and chlorthalidone) tablets, for oral use Initial U.S. Approval: 2011
Approved
Approval ID
e60f795b-fce3-4361-aa03-f143451689d1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 29, 2023
Manufacturers
FDA
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
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 and chlorthalidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60631-412
Application NumberNDA202331
Product Classification
M
Marketing Category
C73594
G
Generic Name
Azilsartan kamedoxomil and chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2022
FDA Product Classification
INGREDIENTS (19)
Azilsartan kamedoxomilActive
Quantity: 40 mg in 1 1
Code: WEC6I2K1FC
Classification: ACTIR
chlorthalidoneActive
Quantity: 12.5 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
polyethylene glycol 8000Inactive
Code: Q662QK8M3B
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
Azilsartan kamedoxomil and chlorthalidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60631-425
Application NumberNDA202331
Product Classification
M
Marketing Category
C73594
G
Generic Name
Azilsartan kamedoxomil and chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2022
FDA Product Classification
INGREDIENTS (19)
Azilsartan kamedoxomilActive
Quantity: 40 mg in 1 1
Code: WEC6I2K1FC
Classification: ACTIR
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
chlorthalidoneActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
polyethylene glycol 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT