Diclofenac Potassium (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HDPE Bottle of 100 Tablets

HDPE Bottle of 100s
(click image for full-size original)

HDPE Bottle of 1000 Tablets

HDPE Bottle of 1000s
(click image for full-size original)
DICLOFENAC POTASSIUM diclofenac potassium tablets tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1832
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
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSES
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off-white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code DP;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70710-1832-1 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70710-1832-0 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215750 05/12/2022
Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
Name Address ID/FEI Operations
UMEDICA LABORATORIES PRIVATE LIMITED 920635096 MANUFACTURE (70710-1832), ANALYSIS (70710-1832)

Revised: 06/2022 Zydus Pharmaceuticals (USA) Inc.

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