NDC Code(s) : 68180-943-11
Packager : Lupin Pharmaceuticals, 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:68180-943
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:68180-943-111 in 1 CARTON 23/02/2018
190 mL in 1 BOTTLE, WITH APPLICATOR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208061 02/23/2018

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - LUPIN LIMITED(675923163)

Establishment
Name Address ID/FEI Business Operations
LUPIN LIMITED 650595213 MANUFACTURE(68180-943), PACK(68180-943)

PRINCIPAL DISPLAY PANEL

Testosterone Topical Solution

30 mg of testosterone per pump actuation CIII

Each actuation delivers 1.5 mL of solution

Multi-dose pump capable of dispensing 60 metered pump actuations.

For topical use only with enclosed applicator

Dispense the enclosed Medication Guide to each patient

Rx Only

NDC 68180-943-11

Carton Label

carton

Testosterone Topical Solution

30 mg of testosterone per pump actuation CIII

Each actuation delivers 1.5 mL of solution

Multi-dose pump capable of dispensing 60 metered pump actuations.

For topical use only with enclosed applicator

Dispense the enclosed Medication Guide to each patient

Rx Only

NDC 68180-943-11

Container Label

carton