NDC Code(s) : 0591-3223-54, 0591-3223-79
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Testosterone CypionateTestosterone Cypionate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3223
Route of Administration INTRAMUSCULAR DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TESTOSTERONE CYPIONATE(UNII: M0XW1UBI14)
(TESTOSTERONE - UNII:3XMK78S47O) 		TESTOSTERONE CYPIONATE200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL BENZOATE(UNII: N863NB338G)
BENZYL ALCOHOL(UNII: LKG8494WBH)
COTTONSEED OIL(UNII: H3E878020N)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3223-541 in 1 CARTON
11 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:0591-3223-791 in 1 CARTON
210 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086030 05/04/2011

PRINCIPAL DISPLAY PANEL

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