DICLOFENAC SODIUM- diclofenac sodium liquid
Zydus Lifesciences Limited

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DICLOFENAC SODIUM TOPICAL SOLUTION

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1415-9

Diclofenac Sodium Topical Solution, 1.5% w/w

Rx only

Quantity 5 Fl. OZ.

(150 mL)

Diclofenac sodiumtopical solution

Diclofenac sodiumtopical solution

Diclofenac sodiumtopical solution

DICLOFENAC SODIUM
diclofenac sodium liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1415
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)	DICLOFENAC SODIUM	16.05 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1415-9	1 in 1 CARTON	08/08/2018
1		150 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206411	08/08/2018

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (650650802)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		650650802	ANALYSIS(70771-1415) , MANUFACTURE(70771-1415)

Revised: 10/2023

Document Id: be77ee21-4c1b-48e6-a256-8efb852ff892

Set id: 3eede6d4-a3e1-4dd4-bb18-a721320f7d10

Version: 5

Effective Time: 20231003

Zydus Lifesciences Limited