NDC Code(s) : 69097-363-44
Packager : Cipla USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TestosteroneTestosterone SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-363
Route of Administration TOPICAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TESTOSTERONE(UNII: 3XMK78S47O)
(TESTOSTERONE - UNII:3XMK78S47O) 		TESTOSTERONE30 mg in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
OCTISALATE(UNII: 4X49Y0596W)
POVIDONE(UNII: FZ989GH94E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-363-441 in 1 CARTON 30/03/2018
190 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209533 03/30/2018

LABELER - Cipla USA Inc.(078719707)

REGISTRANT - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
Cipla Ltd.- Goa 650072015 MANUFACTURE(69097-363)

Establishment
Name Address ID/FEI Business Operations
Aspen Oss B.V 491013870 ANALYSIS(69097-363), API MANUFACTURE(69097-363), PACK(69097-363), STERILIZE(69097-363)

PRINCIPAL DISPLAY PANEL

NDC 69097-363-44

Rx ONLY

Testosterone

Topical Solution

CIII

30 mg of testosterone

per pump actuation*

*Each actuation delivers 1.5 mL of solution

Total contents:

110 mL to deliver 90 mL

Cartonimage

NDC 69097-363-44

Rx ONLY

Testosterone

Topical Solution

CIII

  

30 mg of testosterone

per pump actuation*

*Each actuation delivers 1.5 mL of solution

Total contents:

110 mL to deliver 90 mL

Cartonimage