Diclofenac Potassium (Page 8 of 8)

Principal Display Panel — Bottle Label – 25 mg

NDC 0480-9435-89

Diclofenac Potassium Capsules

25 mg

PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE

Rx only

120 Liquid Filled Capsules

25 mg-Bottle Label
(click image for full-size original)
DICLOFENAC POTASSIUM diclofenac potassium capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-9435
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC POTASSIUM (DICLOFENAC) DICLOFENAC POTASSIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
LACTIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE
WATER
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW)
GELATIN
LECITHIN, SOYBEAN
MEDIUM-CHAIN TRIGLYCERIDES
SORBITAN
SORBITOL
FERROSOFERRIC OXIDE
POLYVINYL ACETATE PHTHALATE
PROPYLENE GLYCOL
Product Characteristics
Color yellow (translucent) Score no score
Shape CAPSULE (liquid-filled capsules) Size 15mm
Flavor Imprint Code TV;9435
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-9435-89 120 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204648 03/24/2022
Labeler — TEVA PHARMACEUTICALS, INC. (022629579)
Registrant — Bionpharma Inc. (079637826)
Establishment
Name Address ID/FEI Operations
Patheon Softgels Inc. 002193829 manufacture (0480-9435)

Revised: 03/2022 TEVA PHARMACEUTICALS, INC.

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