NDC Code(s) : 0009-0347-02, 0009-0417-01, 0009-0417-02
Packager : Pharmacia & Upjohn Company LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Depo-Testosteronetestosterone cypionate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-0347
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 CYPIONATE100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL BENZOATE(UNII: N863NB338G)0.1 mL in 1 mL
COTTONSEED OIL(UNII: H3E878020N)736 mg in 1 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)9.45 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0009-0347-021 in 1 CARTON 25/07/1979
110 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085635 07/25/1979
Depo-Testosteronetestosterone cypionate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-0417
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)0.2 mL in 1 mL
COTTONSEED OIL(UNII: H3E878020N)560 mg in 1 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)9.45 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0009-0417-011 in 1 CARTON 25/07/1979
11 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:0009-0417-021 in 1 CARTON 25/07/1979
210 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085635 07/25/1979

LABELER - Pharmacia & Upjohn Company LLC(618054084)

Establishment
Name Address ID/FEI Business Operations
Pharmacia & Upjohn Company LLC 618054084 ANALYSIS(0009-0347, 0009-0417), API MANUFACTURE(0009-0347, 0009-0417), LABEL(0009-0347, 0009-0417), MANUFACTURE(0009-0347, 0009-0417), PACK(0009-0347, 0009-0417)

PRINCIPAL DISPLAY PANEL

NDC 0009-0347-02

10 mL Vial
Multiple-Dose

Depo®-Testosterone
testosterone cypionate
injection, USP
CIII

1,000 mg/10 mL
(100 mg/mL)

For intramuscular use only

Rx only

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 100 mg/mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0009-0347-02

One 10 mL Vial
Multiple-Dose

Depo®-
Testosterone
testosterone cypionate
injection, USP
CIII

1,000 mg/10 mL
(100 mg/mL)

For intramuscular
use only

Rx only

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 100 mg/mL Vial Carton

PRINCIPAL DISPLAY PANEL

1 mL Vial
NDC 0009-0417-01

Depo®-
Testosterone
testosterone cypionate
injection, USP
CIII

200 mg/mL

For IM use only

Single-dose

Rx only

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 200 mg/mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0009-0417-01

One 1 mL Vial
Single-dose

Depo®-
Testosterone
testosterone cypionate
injection, USP
CIII

200 mg/mL

For intramuscular
use only

Rx only

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 200 mg/mL Vial Carton