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

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

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

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

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

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 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.