NDC 0591-3223-79
API & Excipient Details

Testosterone Cypionate marketed by Actavis Pharma, Inc. under NDC Code 0591-3223-79

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TESTOSTERONE CYPIONATE(UNII: M0XW1UBI14) (TESTOSTERONE - UNII:3XMK78S47O)	TESTOSTERONE CYPIONATE	200 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZYL BENZOATE(UNII: N863NB338G)
BENZYL ALCOHOL(UNII: LKG8494WBH)
COTTONSEED OIL(UNII: H3E878020N)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0591-3223-54	1 in 1 CARTON
1		1 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2	NDC:0591-3223-79	1 in 1 CARTON
2		10 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA086030	05/04/2011

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