NDC Code(s) : 69097-423-02, 69097-423-03, 69097-422-12, 69097-422-02, 69097-422-19, 69097-422-21, 69097-422-07, 69097-421-07, 69097-421-12, 69097-421-02, 69097-421-19, 69097-421-21, 69097-420-02, 69097-420-03, 69097-420-11, 69097-420-19, 69097-420-21
Packager : Cipla USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CELECOXIB CELECOXIB CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-423
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)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
GELATIN(UNII: 2G86QN327L)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code Cipla;423;50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-423-0230 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
2NDC:69097-423-0360 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207446 09/23/2015
CELECOXIB CELECOXIB CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-422
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)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
GELATIN(UNII: 2G86QN327L)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code Cipla;422;100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-422-12500 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
2NDC:69097-422-0230 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
3NDC:69097-422-2110 in 1 CARTON 23/09/2015
3NDC:69097-422-1910 in 1 BLISTER PACK Type 0: Not a Combination Product23/09/2015
4NDC:69097-422-07100 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207446 09/23/2015
CELECOXIB CELECOXIB CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-421
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)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
GELATIN(UNII: 2G86QN327L)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code Cipla;421;200
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-421-07100 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
2NDC:69097-421-12500 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
3NDC:69097-421-0230 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
4NDC:69097-421-2110 in 1 CARTON 23/09/2015
4NDC:69097-421-1910 in 1 BLISTER PACK Type 0: Not a Combination Product23/09/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207446 09/23/2015
CELECOXIB CELECOXIB CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-420
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)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
GELATIN(UNII: 2G86QN327L)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code Cipla;420;400
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-420-0230 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
2NDC:69097-420-0360 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
3NDC:69097-420-11480 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
4NDC:69097-420-2110 in 1 CARTON 23/09/2015
4NDC:69097-420-1910 in 1 BLISTER PACK Type 0: Not a Combination Product23/09/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207446 09/23/2015

LABELER - Cipla USA Inc.(078719707)

REGISTRANT - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
Cipla Limited- Kurkumbh 917066446 API MANUFACTURE(69097-423, 69097-422, 69097-421, 69097-420), MANUFACTURE(69097-423, 69097-422, 69097-421, 69097-420), ANALYSIS(69097-423, 69097-422, 69097-421, 69097-420)

Establishment
Name Address ID/FEI Business Operations
Cipla Ltd. Indore 918596409 ANALYSIS(69097-422, 69097-421), MANUFACTURE(69097-422, 69097-421), LABEL(69097-422, 69097-421), PACK(69097-422, 69097-421)

PRINCIPAL DISPLAY PANEL

50 mg Bottle Label

Rx only

NDC 69097-423-03

Celecoxib Capsules

50 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient

60 Capsules

Cipla

50 mg bottle label

100 mg Bottle Label

Rx only

NDC 69097-422-07

Celecoxib Capsules

100 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient

100 Capsules

Cipla

50 mg bottle label

100 mg 10 Blister Pack

Rx only

NDC 69097-422-19

Celecoxib Capsules

100 mg

10 Capsules

Cipla

50 mg bottle label

100 mg 10 x 10 Blister Pack carton

Rx only

NDC 69097-422-21

Celecoxib Capsules

100 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient

100 (10 x 10) Unit-dose Capsules

Cipla

50 mg bottle label

200 mg Bottle Label

Rx only

NDC 69097-421-07

Celecoxib Capsules

200 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient

100 Capsules

Cipla

50 mg bottle label

200 mg 10 Blister Pack

Rx only

NDC 69097-421-19

Celecoxib Capsules

200 mg

10 Capsules

Cipla

50 mg bottle label

200 mg 10 x 10 Blister Pack carton

Rx only

NDC 69097-421-21

Celecoxib Capsules

200 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient

100 (10 x 10) Unit-dose Capsules

Cipla

50 mg bottle label

400 mg Bottle Label

Rx only

NDC 69097-420-03

Celecoxib Capsules

400 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient

60 Capsules

Cipla

50 mg bottle label

400 mg 10 Blister Pack

Rx only

NDC 69097-420-19

Celecoxib Capsules

400 mg

10 Capsules

Cipla

50 mg bottle label

400 mg 10 x 10 Blister Pack carton

Rx only

NDC 69097-420-21

Celecoxib Capsules

400 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient

100 (10 x 10) Unit-dose Capsules

Cipla

50 mg bottle label