Celecoxib (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 50 mg label

NDC 60505-3847-6

60 Capsules Rx only

Celecoxib capsules

50 mg

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PRINICIPAL DISPLAY PANEL — 100 mg label

NDC 60505-3848-1

100 Capsules Rx only

Celecoxib capsules

100 mg

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PRINCIPAL DISPLAY PANEL — 200 mg label

NDC 60505-3849-1

100 Capsules Rx only

Celecoxib capsules

200 mg

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CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3847
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
Crospovidone
GELATIN
MAGNESIUM STEARATE
POVIDONE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
SODIUM HYDROXIDE
FD&C RED NO. 40
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code APO;C50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-3847-3 30 CAPSULE in 1 BOTTLE None
2 NDC:60505-3847-6 60 CAPSULE in 1 BOTTLE None
3 NDC:60505-3847-1 100 CAPSULE in 1 BOTTLE None
4 NDC:60505-3847-8 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204197 06/03/2015
CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3848
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
CROSPOVIDONE
GELATIN
MAGNESIUM STEARATE
POVIDONE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
AMMONIA
FD&C BLUE NO. 2
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code APO;C100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-3848-3 30 CAPSULE in 1 BOTTLE None
2 NDC:60505-3848-1 100 CAPSULE in 1 BOTTLE None
3 NDC:60505-3848-5 500 CAPSULE in 1 BOTTLE None
4 NDC:60505-3848-8 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204197 06/03/2015
CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3849
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
CROSPOVIDONE
GELATIN
MAGNESIUM STEARATE
POVIDONE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
AMMONIA
FERRIC OXIDE YELLOW
DIMETHICONE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code APO;C200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-3849-3 30 CAPSULE in 1 BOTTLE None
2 NDC:60505-3849-1 100 CAPSULE in 1 BOTTLE None
3 NDC:60505-3849-5 500 CAPSULE in 1 BOTTLE None
4 NDC:60505-3849-8 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204197 06/03/2015
Labeler — Apotex Corp. (845263701)
Registrant — Apotex Inc. (209429182)
Establishment
Name Address ID/FEI Operations
Apotex Inc. 205576023 manufacture (60505-3847), manufacture (60505-3848), manufacture (60505-3849), analysis (60505-3847), analysis (60505-3848), analysis (60505-3849)

Revised: 05/2021 Apotex Corp.

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