Celecoxib (Page 13 of 13)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-259(NDC:50228-158)
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
FERRIC OXIDE YELLOW
CROSCARMELLOSE SODIUM
GELATIN, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code SG;158
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-259-30 30 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:72789-259-14 14 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:72789-259-60 60 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205129 12/03/2020
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (72789-259)

Revised: 09/2022 PD-Rx Pharmaceuticals, Inc.

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