CELEBREX
These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX (celecoxib) capsulesInitial U.S. Approval: 1998
Approved
Approval ID
b6bd0101-ebf0-43e8-99bf-21cb032b05d6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 2
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 Code52959-539
Application NumberNDA020998
Product Classification
M
Marketing Category
C73594
G
Generic Name
Celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2011
FDA Product Classification
INGREDIENTS (7)
povidoneInactive
Code: FZ989GH94E
Classification: IACT
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
Celecoxib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-540
Application NumberNDA020998
Product Classification
M
Marketing Category
C73594
G
Generic Name
Celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2011
FDA Product Classification
INGREDIENTS (7)
CelecoxibActive
Quantity: 100 mg in 1 1
Code: JCX84Q7J1L
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 9/2/2011