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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) capsules, for oral useInitial U.S. Approval: 1998

Approved
Approval ID

8d52185d-421f-4e34-8db7-f7676db2a226

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 15, 2021

Manufacturers
FDA

PFIZER LABORATORIES DIV PFIZER INC

DUNS: 134489525

Products 4

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 Code0025-1525
Application NumberNDA020998
Product Classification
M
Marketing Category
C73594
G
Generic Name
Celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2021
FDA Product Classification

INGREDIENTS (7)

CELECOXIBActive
Quantity: 200 mg in 1 1
Code: JCX84Q7J1L
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

Celecoxib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0025-1520
Application NumberNDA020998
Product Classification
M
Marketing Category
C73594
G
Generic Name
Celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2021
FDA Product Classification

INGREDIENTS (7)

CELECOXIBActive
Quantity: 100 mg in 1 1
Code: JCX84Q7J1L
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT

Celecoxib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0025-1515
Application NumberNDA020998
Product Classification
M
Marketing Category
C73594
G
Generic Name
Celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2021
FDA Product Classification

INGREDIENTS (7)

CELECOXIBActive
Quantity: 50 mg in 1 1
Code: JCX84Q7J1L
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

Celecoxib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0025-1530
Application NumberNDA020998
Product Classification
M
Marketing Category
C73594
G
Generic Name
Celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2021
FDA Product Classification

INGREDIENTS (7)

CELECOXIBActive
Quantity: 400 mg in 1 1
Code: JCX84Q7J1L
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

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