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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

0dcc7017-31c2-4979-ad33-2dc7f7a53d43

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 7, 2013

Manufacturers
FDA

Dispensing Solutions, Inc.

DUNS: 066070785

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 Code66336-940
Application NumberNDA020998
Product Classification
M
Marketing Category
C73594
G
Generic Name
CELECOXIB
Product Specifications
Route of AdministrationORAL
Effective DateNovember 6, 2013
FDA Product Classification

INGREDIENTS (7)

CELECOXIBActive
Quantity: 100 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
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

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CELEBREX - FDA Drug Approval Details