ATACAND
These highlights do not include all the information needed to use ATACAND safely and effectively. See full prescribing information for ATACAND. ATACAND (candesartan cilexetil) tablets, for oral useInitial U.S. Approval: 1998
Approved
Approval ID
fd676896-5f5b-48da-becc-3736a6fc1f14
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2016
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Candesartan cilexetil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68151-4146
Application NumberNDA020838
Product Classification
M
Marketing Category
C73594
G
Generic Name
Candesartan cilexetil
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2016
FDA Product Classification
INGREDIENTS (8)
CANDESARTAN CILEXETILActive
Quantity: 8 mg in 1 1
Code: R85M2X0D68
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT