CELECOXIB (Page 11 of 11)

PRINCIPAL DISPLAY PANEL

NDC: 51655-059-52

Label
(click image for full-size original)
CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-059(NDC:69097-422)
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
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
SODIUM LAURYL SULFATE
GELATIN
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Cipla;422;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-059-52 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207446 03/03/2023
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals, LLC 036986393 repack (51655-059)

Revised: 04/2023 Northwind Pharmaceuticals, LLC

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