Testosterone Cypionate (Page 3 of 3)

HOW SUPPLIED

Testosterone cypionate injection, USP is available as follows:

100 mg/mL

10 mL Multiple-dose vials NDC 62756-017-40

200 mg/mL

1 mL Single-dose vials NDC 62756-015-40
10 mL Multiple-dose vials NDC 62756-016-40

Vials should be store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Manufactured by:

Sun Pharmaceutical Industries Ltd.

Halol-Baroda Highway,

Halol-389 350, Gujarat, India

ISS. 11/2020

PJPI0281K

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1000mg/10mL-LABEL

NDC 62756-017-40
Testosterone Cypionate Injection, USP CIII
1,000 mg/10 mL (100 mg/mL)
FOR INRAMUSCULAR USE ONLY
Rx only10 mL Multiple-Dose Vial

testosterone-label-1000mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1000mg/10mL-SHOWBOX

NDC 62756-017-40
Testosterone Cypionate Injection, USP CIII
1,000 mg/10 mL (100 mg/mL)
FOR INRAMUSCULAR USE ONLY
Rx only
One 10 mL Multiple-Dose VialSUN PHARMA

testosterone-showbox-1000mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-200mg/1mL-LABEL

NDC 62756-015-40
Testosterone Cypionate Injection, USP CIII
200 mg/mL
FOR INRAMUSCULAR USE ONLY
Rx only
1 mL Single-dose vial

testosterone-label-200mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-200mg/1mL-SHOWBOX

NDC 62756-015-40
Testosterone Cypionate Injection, USP CIII
200 mg/mL
FOR INRAMUSCULAR USE ONLY
Rx only
One 1 mL Single-dose vial SUN PHARMA

testosterone-showbox-200mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-2000mg/10mL-LABEL

NDC 62756-016-40
Testosterone Cypionate Injection, USP CIII
2,000 mg/10 mL (200 mg/mL)
FOR INRAMUSCULAR USE ONLY
Rx only10 mL Multiple-Dose Vial

testosterone-label-2000mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-2000mg/10mL-SHOWBOX

NDC 62756-016-40
Testosterone Cypionate Injection, USP CIII
2,000 mg/10 mL (200 mg/mL)
FOR INRAMUSCULAR USE ONLY
Rx only
One 10 mL Multiple-Dose VialSUN PHARMA

testosterone-showbox-2000mg
(click image for full-size original)
TESTOSTERONE CYPIONATE testosterone cypionate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-017
Route of Administration INTRAMUSCULAR DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TESTOSTERONE CYPIONATE (TESTOSTERONE) TESTOSTERONE CYPIONATE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL BENZOATE 0.1 mL in 1 mL
COTTONSEED OIL 736 mg in 1 mL
BENZYL ALCOHOL 9.45 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62756-017-40 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (62756-017-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201720 06/17/2013
TESTOSTERONE CYPIONATE testosterone cypionate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-015
Route of Administration INTRAMUSCULAR DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TESTOSTERONE CYPIONATE (TESTOSTERONE) TESTOSTERONE CYPIONATE 200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL BENZOATE 0.2 mL in 1 mL
COTTONSEED OIL 560 mg in 1 mL
BENZYL ALCOHOL 9.45 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62756-015-40 1 VIAL in 1 CARTON contains a VIAL
1 1 mL in 1 VIAL This package is contained within the CARTON (62756-015-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201720 06/17/2013
TESTOSTERONE CYPIONATE testosterone cypionate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-016
Route of Administration INTRAMUSCULAR DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TESTOSTERONE CYPIONATE (TESTOSTERONE) TESTOSTERONE CYPIONATE 200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL BENZOATE 0.2 mL in 1 mL
COTTONSEED OIL 560 mg in 1 mL
BENZYL ALCOHOL 9.45 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62756-016-40 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (62756-016-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201720 06/17/2013
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS (62756-015), ANALYSIS (62756-016), ANALYSIS (62756-017), MANUFACTURE (62756-015), MANUFACTURE (62756-016), MANUFACTURE (62756-017)

Revised: 08/2021 Sun Pharmaceutical Industries, Inc.

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