Celecoxib 200 Mg (Page 9 of 9)

Packaging

celecoxib 200mg
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CELECOXIB 200 MG celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69399-194
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
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN
SHELLAC
PROPYLENE GLYCOL
FERRIC OXIDE RED
POVIDONE K30
Product Characteristics
Color white (Opaque white) Score no score
Shape capsule Size 19mm
Flavor Imprint Code A;136
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69399-194-81 100 CAPSULE in 1 BOTTLE None
2 NDC:69399-194-85 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204519 03/17/2017
Labeler — SYDON LABS LLC (079598461)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 manufacture (69399-194)

Revised: 03/2017 SYDON LABS LLC

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