CELEBREX

Basic Information

Product Name

CELEBREX

FDA Product Code

49999-383

Regulatory Information

NDC Product Code

49999-383

Application Number

NDA020998

Marketing Category

C73594

Effective Date

March 16, 2017

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

3247

Active Ingredients

croscarmellose sodium

Code: M28OL1HH48

Class Code: IACT

Celecoxib

Quantity: 100 mg in 1 1

Code: JCX84Q7J1L

Class Code: ACTIB

lactose monohydrate

Code: EWQ57Q8I5X

Class Code: IACT

gelatin

Code: 2G86QN327L

Class Code: IACT

magnesium stearate

Code: 70097M6I30

Class Code: IACT

povidone

Code: FZ989GH94E

Class Code: IACT

sodium lauryl sulfate

Code: 368GB5141J

Class Code: IACT

Active Moieties

Celecoxib

Code: JCX84Q7J1L

Basic Information

Regulatory Information

Company Information

Active Ingredients

croscarmellose sodium

lactose monohydrate

gelatin

magnesium stearate

povidone

sodium lauryl sulfate

Active Moieties

Celecoxib