NDC Code(s) : 69097-524-44
Packager : Cipla USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diclofenac Sodium Diclofenac Sodium GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-524
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM(UNII: QTG126297Q)
(DICLOFENAC - UNII:144O8QL0L1) 		DICLOFENAC SODIUM10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 4Q93RCW27E)
COCO-CAPRYLATE/CAPRATE(UNII: 8D9H4QU99H)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MINERAL OIL(UNII: T5L8T28FGP)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
AMMONIA(UNII: 5138Q19F1X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-524-441 in 1 CARTON 16/08/2018
1100 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209903 08/16/2018

LABELER - Cipla USA Inc.(078719707)

REGISTRANT - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
Cipla Ltd. Goa 650072015 MANUFACTURE(69097-524)

Establishment
Name Address ID/FEI Business Operations
DPT Laboratories Ltd. 832224526 MANUFACTURE(69097-524), ANALYSIS(69097-524)

PRINCIPAL DISPLAY PANEL

NDC 69097-524-44

Diclofenac Sodium Topical Gel

1%

For Topical Use Only

Net Wt 100 g

USE THE DOSING CARD ATTACHED INSIDE THE CARTON

Cipla

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