Celecoxib
These highlights do not include all the information needed to use CELECOXIB capsules safely and effectively. See full prescribing information for CELECOXIB capsules. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
23e5c271-3d06-5a63-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 21, 2016
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 Code10544-953
Application NumberANDA204197
Product Classification
M
Marketing Category
C73584
G
Generic Name
Celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2016
FDA Product Classification
INGREDIENTS (15)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
CELECOXIBActive
Quantity: 200 mg in 1 1
Code: JCX84Q7J1L
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT