Celecoxib
These highlights do not include all the information needed to use celecoxib safely and effectively. See full prescribing information for celecoxib. Celecoxib Capsules Initial U.S. Approval: 1998
Approved
Approval ID
1b53f099-4eae-2ee2-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2015
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Celecoxib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10544-929
Application NumberNDA020998
Product Classification
M
Marketing Category
C73605
G
Generic Name
Celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateJuly 20, 2015
FDA Product Classification
INGREDIENTS (7)
CELECOXIBActive
Quantity: 200 mg in 1 1
Code: JCX84Q7J1L
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT