Celecoxib

Basic Information

Product Name

Celecoxib

FDA Product Code

59762-1518

Regulatory Information

NDC Product Code

59762-1518

Application Number

NDA020998

Marketing Category

C73605

Effective Date

May 14, 2021

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use celecoxib safely and effectively. See full prescribing information for celecoxib. Celecoxib capsules, for oral use Initial U.S. Approval: 1998

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CELECOXIB

Quantity: 400 mg in 1 1

Code: JCX84Q7J1L

Class Code: ACTIB

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

Active Moieties

Code: JCX84Q7J1L

Celecoxib

Basic Information

Regulatory Information

Company Information

Active Ingredients

CROSCARMELLOSE SODIUM

GELATIN, UNSPECIFIED

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

POVIDONE, UNSPECIFIED

SODIUM LAURYL SULFATE

Active Moieties

CELECOXIB