Celecoxib (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL — 50 mg Bottle Label



PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT.
NDC 71209-054-03
Celecoxib capsules
50 mg
60 CapsulesRx only

container-label-50mg-60packs
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg Bottle Label
PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT.
NDC 71209-055-03
Celecoxib capsules
100 mg
60 CapsulesRx only

container-label-100mg-60packs
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg Bottle Label
PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT.
NDC 71209-056-03
Celecoxib capsules
200 mg
60 CapsulesRx only

container-label-200mg-60packs
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 400 mg Bottle Label
PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT.
NDC 71209-057-03
Celecoxib capsules
400 mg
60 Capsules
Rx only

container-label-400mg-60packs
(click image for full-size original)

CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71209-054
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB (CELECOXIB) CELECOXIB 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSPOVIDONE
SODIUM LAURYL SULFATE
POVIDONE K30
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
AMMONIA
WATER
ALCOHOL
Product Characteristics
Color WHITE, RED Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code C85;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71209-054-03 60 CAPSULE in 1 BOTTLE None
2 NDC:71209-054-11 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208701 12/09/2015
CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71209-055
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB (CELECOXIB) CELECOXIB 100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSPOVIDONE
SODIUM LAURYL SULFATE
POVIDONE K30
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
SHELLAC
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
FERROSOFERRIC OXIDE
AMMONIA
WATER
ALCOHOL
Product Characteristics
Color WHITE, BLUE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code C86;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71209-055-03 60 CAPSULE in 1 BOTTLE None
2 NDC:71209-055-11 1000 CAPSULE in 1 BOTTLE None
3 NDC:71209-055-05 100 CAPSULE in 1 BOTTLE None
4 NDC:71209-055-10 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208701 12/08/2015
CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71209-056
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB (CELECOXIB) CELECOXIB 200 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSPOVIDONE
SODIUM LAURYL SULFATE
POVIDONE K30
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
AMMONIA
WATER
ALCOHOL
Product Characteristics
Color WHITE, YELLOW (GOLD) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code C87;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71209-056-03 60 CAPSULE in 1 BOTTLE None
2 NDC:71209-056-11 1000 CAPSULE in 1 BOTTLE None
3 NDC:71209-056-05 100 CAPSULE in 1 BOTTLE None
4 NDC:71209-056-10 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208701 12/15/2015
CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71209-057
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB (CELECOXIB) CELECOXIB 400 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSPOVIDONE
SODIUM LAURYL SULFATE
POVIDONE K30
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
SHELLAC
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
AMMONIA
WATER
ALCOHOL
Product Characteristics
Color WHITE, GREEN Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code C88;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71209-057-03 60 CAPSULE in 1 BOTTLE None
2 NDC:71209-057-20 600 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208701 12/15/2015
Labeler — Cadila Pharmaceuticals Limited (862257719)
Establishment
Name Address ID/FEI Operations
Cadila Pharmaceuticals Limited 918451696 ANALYSIS (71209-054), ANALYSIS (71209-055), ANALYSIS (71209-056), ANALYSIS (71209-057), LABEL (71209-054), LABEL (71209-055), LABEL (71209-056), LABEL (71209-057), MANUFACTURE (71209-054), MANUFACTURE (71209-055), MANUFACTURE (71209-056), MANUFACTURE (71209-057), PACK (71209-054), PACK (71209-055), PACK (71209-056), PACK (71209-057)

Revised: 09/2021 Cadila Pharmaceuticals Limited

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