NDC Code(s) : 21922-009-09
Packager : Encube Ethicals Private Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diclofenac Sodium Diclofenac Sodium Topical Gel, 1%, GEL
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:21922-009
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
ISOPROPYL ALCOHOL(UNII: ND2M416302)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER TYPE C(UNII: 4Q93RCW27E)
MINERAL OIL(UNII: T5L8T28FGP)
COCO-CAPRYLATE/CAPRATE(UNII: 8D9H4QU99H)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
WATER(UNII: 059QF0KO0R)
AMMONIA(UNII: 5138Q19F1X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:21922-009-091 in 1 CARTON 30/01/2020
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 ANDA210986 01/30/2020

LABELER - Encube Ethicals Private Limited(915834105)

REGISTRANT - Encube Ethicals Private Limited(915834105)

Establishment
Name Address ID/FEI Business Operations
Encube Ethicals Private Limited 725076298 ANALYSIS(21922-009), MANUFACTURE(21922-009)

PRINCIPAL DISPLAY PANEL

See Medication Guide and Patient Instructions Inside of Carton

Carton Label

NDC 21922-009-09

Diclofenac sodium topical gel 1%

For Topical Use Only


Rx only

100 g

Use the Dosing Card Attached Inside Carton

 


diclo-carton

 Container Label

NDC 21922-009-09


Diclofenac sodium topical gel 1% 

For Topical Use Only

Rx only

100 g

 diclo-carton


Dosing Card

NDC 21922-009-09

Diclofenac sodium topical gel 1%

For Topical Use Only


Rx only

100 g


diclo-carton