NDC Code(s) : 0591-2817-60, 0591-2820-01, 0591-2820-05, 0591-2825-01, 0591-2825-05, 0591-2831-60
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CelecoxibCelecoxib CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2817
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:0591-2817-6060 in 1 BOTTLE Type 0: Not a Combination Product10/12/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020998 12/10/2014 08/31/2016
CelecoxibCelecoxib CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2820
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:0591-2820-01100 in 1 BOTTLE Type 0: Not a Combination Product10/12/2014
2NDC:0591-2820-05500 in 1 BOTTLE Type 0: Not a Combination Product10/12/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020998 12/10/2014 05/31/2018
CelecoxibCelecoxib CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2825
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:0591-2825-01100 in 1 BOTTLE Type 0: Not a Combination Product10/12/2014
2NDC:0591-2825-05500 in 1 BOTTLE Type 0: Not a Combination Product10/12/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020998 12/10/2014 04/30/2018
CelecoxibCelecoxib CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2831
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:0591-2831-6060 in 1 BOTTLE Type 0: Not a Combination Product10/12/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020998 12/10/2014 08/31/2017

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label

NDC 0591-2817-60

ALWAYS DISPENSE WITH MEDICATION GUIDE

Celecoxib
Capsules

50
mg

Actavis

60 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label

NDC 0591-2820-01

ALWAYS DISPENSE WITH MEDICATION GUIDE

Celecoxib
Capsules

100
mg

Actavis

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label

NDC 0591-2825-01

ALWAYS DISPENSE WITH MEDICATION GUIDE

Celecoxib
Capsules

200
mg

Actavis

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 400 mg Capsule Bottle Label

NDC 0591-2831-60

ALWAYS DISPENSE WITH MEDICATION GUIDE

Celecoxib
Capsules

400
mg

Actavis

60 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 400 mg Capsule Bottle Label