Celecoxib (Page 11 of 11)

CELECOXIB

Label ImageLabel Image
CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-5638(NDC:68180-399)
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
CROSCARMELLOSE SODIUM
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
POVIDONE K30
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (Gold Opaque Cap) , WHITE (White Opaque Body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code LU;N43
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-5638-1 60 CAPSULE in 1 BOTTLE None
2 NDC:50090-5638-0 30 CAPSULE in 1 BOTTLE None
3 NDC:50090-5638-2 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202240 12/09/2019
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5638), REPACK (50090-5638)

Revised: 09/2021 A-S Medication Solutions

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