Diclofenac Potassium (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diclofenac oral solution sachet label-50 mg

diclofenacossachetlabel-50-mg
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Diclofenac oral solution carton label-50 mg

diclofenacoscartonlabel50mg
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DICLOFENAC POTASSIUM diclofenac potassium powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-046
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC POTASSIUM (DICLOFENAC) DICLOFENAC POTASSIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
SUCRALOSE
TRIBASIC SODIUM PHOSPHATE
PEPPERMINT
GLYCERYL BEHENATE/EICOSADIOATE
Product Characteristics
Color white (white to off-white) Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-046-31 1 POWDER, FOR SOLUTION in 1 PACKET None
2 NDC:31722-046-32 9 POWDER, FOR SOLUTION in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215375 03/04/2022
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Annora Pharma Private Limited 650980746 analysis (31722-046), manufacture (31722-046)

Revised: 06/2022 Camber Pharmaceuticals, Inc.

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