NDC Code(s) : 0025-1515-01, 0025-1520-31, 0025-1520-51, 0025-1520-34, 0025-1525-31, 0025-1525-51, 0025-1525-34, 0025-1525-99, 0025-1525-96, 0025-1530-02, 0025-1530-01
Packager : PFIZER LABORATORIES DIV PFIZER INC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CELEBREXCelecoxib CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0025-1515
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB(UNII: JCX84Q7J1L)
(CELECOXIB - UNII:JCX84Q7J1L) 		CELECOXIB50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code 7767;50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0025-1515-0160 in 1 BOTTLE Type 0: Not a Combination Product10/02/1998
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020998 10/02/1998 08/31/2024
CELEBREXCelecoxib CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0025-1520
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB(UNII: JCX84Q7J1L)
(CELECOXIB - UNII:JCX84Q7J1L) 		CELECOXIB100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code 7767;100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0025-1520-31100 in 1 BOTTLE Type 0: Not a Combination Product10/02/1998
2NDC:0025-1520-51500 in 1 BOTTLE Type 0: Not a Combination Product10/02/1998
3NDC:0025-1520-34100 in 1 CARTON 10/02/1998
31 in 1 BLISTER PACK Type 0: Not a Combination Product10/02/1998
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020998 10/02/1998
CELEBREXCelecoxib CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0025-1525
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB(UNII: JCX84Q7J1L)
(CELECOXIB - UNII:JCX84Q7J1L) 		CELECOXIB200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code 7767;200
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0025-1525-31100 in 1 BOTTLE Type 0: Not a Combination Product10/02/1998
2NDC:0025-1525-51500 in 1 BOTTLE Type 0: Not a Combination Product10/02/1998
3NDC:0025-1525-34100 in 1 CARTON 10/02/1998
31 in 1 BLISTER PACK Type 0: Not a Combination Product10/02/1998
4NDC:0025-1525-964 in 1 BOX 10/02/1998
4NDC:0025-1525-991 in 1 CARTON 10/02/1998
43 in 1 BLISTER PACK Type 0: Not a Combination Product10/02/1998
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020998 10/02/1998
CELEBREXCelecoxib CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0025-1530
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB(UNII: JCX84Q7J1L)
(CELECOXIB - UNII:JCX84Q7J1L) 		CELECOXIB400 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code 7767;400
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0025-1530-0260 in 1 BOTTLE Type 0: Not a Combination Product10/02/1998
2NDC:0025-1530-01100 in 1 CARTON 10/02/1998
21 in 1 BLISTER PACK Type 0: Not a Combination Product10/02/1998
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020998 10/02/1998 08/31/2024

LABELER - PFIZER LABORATORIES DIV PFIZER INC(134489525)

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0025-1515-01

Pfizer

Celebrex ®
celecoxib capsules

50 mg

60 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 50 mg Bottle Label

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0025-1520-31

Pfizer

Celebrex ®
celecoxib capsules

100 mg

100 Capsules
Rx only

Principal Display Panel - 100 mg Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 100 mg Blister Pack

Celebrex®
celecoxib capsules

100 mg

Distributed by
G.D. Searle LLC
Div of Pfizer Inc, NY, NY 10017
MADE IN SINGAPORE

Principal Display Panel - 100 mg Blister Pack

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer

NDC 0025-1520-34
Rx only

Celebrex®
celecoxib capsules

100 mg

For in-institution use only

100 Capsules
UNIT DOSE

PRINCIPAL DISPLAY PANEL - 100 mg Capsule Blister Pack Carton

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0025-1525-31

Pfizer

Celebrex ®
celecoxib capsules

200 mg

100 Capsules
Rx only

Principal Display Panel - 200 mg Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 200 mg Blister Pack

Celebrex®
celecoxib capsules

200 mg

Distributed by
G.D. Searle LLC
Div of Pfizer Inc, NY, NY 10017
MADE IN SINGAPORE

Principal Display Panel - 200 mg Blister Pack

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer

NDC 0025-1525-34
Rx only

Celebrex®
celecoxib capsules

200 mg

For in-institution use only

100 Capsules
UNIT DOSE

Principal Display Panel - 200 mg Capsule Blister Pack Carton

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

CELEBREX ®
(CELECOXIB) CAPSULES

200 mg

1-800-249-2692
www.celebrex.com

200 mg
200 mg
200 mg

Principal Display Panel - 200 mg Capsule Sample Blister Pack

PRINCIPAL DISPLAY PANEL

NDC 0025-1525-99
Rx only

PROFESSIONAL SAMPLE – NOT FOR SALE

ALWAYS DISPENSE WITH MEDICATION GUIDE

Contains: 1 blister x 3 capsules

CELEBREX ®
(CELECOXIB) CAPSULES

200 mg per capsule

For patient information, please call 1-800-249-2692
or visit our web site at www.celebrex.com

Principal Display Panel - 200 mg Capsule Sample Blister Pack Carton

PRINCIPAL DISPLAY PANEL

PROFESSIONAL SAMPLE – NOT FOR SALE

ALWAYS DISPENSE WITH MEDICATION GUIDE

Contains: 4 blisters x 3 capsules each

NDC 0025-1525-96
Contains 4 of NDC 0025-1525-99

CELEBREX ®
(CELECOXIB) CAPSULES

200 mg per capsule
Rx only

For patient information, please call 1-800-249-2692
or visit our web site at www.celebrex.com

Principal Display Panel - 200 mg Capsule Sample Blister Pack Box

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0025-1530-02

Pfizer

Celebrex ®
celecoxib capsules

400 mg

60 Capsules
Rx only

Principal Display Panel - 400 mg Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 400 mg Blister Pack

Celebrex®
celecoxib capsules

400 mg

Distributed by
G.D. Searle LLC
Div of Pfizer Inc, NY, NY 10017
MADE IN SINGAPORE

Principal Display Panel - 400 mg Blister Pack

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer

NDC 0025-1530-01
Rx only

Celebrex®
celecoxib capsules

400 mg

For in-institution use only

100 Capsules
UNIT DOSE

Principal Display Panel - 400 mg Capsule Blister Pack Carton