Levothyroxine Sodium (Page 3 of 3)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility of Levothyroxine Sodium for Injection.

13.2 Animal Toxicology and Pharmacology

No animal toxicology studies have been conducted with Levothyroxine Sodium for Injection.

14 CLINICAL STUDIES

No clinical studies have been conducted with Levothyroxine Sodium for Injection in patients with myxedema coma. However, data from published literature support the intravenous use of levothyroxine sodium for the treatment of myxedema coma.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Levothyroxine Sodium for Injection is supplied as follows:

NDC Levothyroxine Sodium for Injection Reconstituted Concentration Package Factor
70860-451-10 100 mcg Single-Dose Vial 20 mcg per mL 1 vial per carton
70860-452-10 200 mcg Single-Dose Vial 40 mcg per mL 1 vial per carton
70860-453-10 500 mcg Single-Dose Vial 100 mcg per mL 1 vial per carton

16.2 Storage and Handling

Store dry product at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light.
Discard any unused portion.

Sterile, Nonpyrogenic, Preservative-free, Lyophilized.
The container closure is not made with natural rubber latex.

Athenex
Mfd. for Athenex
Schaumburg, IL 60173 (USA)
Made in India©2018 Athenex.

September 2018

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 70860-451-10

Levothyroxine Sodium for Injection

100 mcg per vial

Rx only

For Intravenous Use

Single-Dose Vial

Discard any unused portion

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 70860-452-10

Levothyroxine Sodium for Injection

200 mcg per vial

Rx only

For Intravenous Use

Single-Dose Vial

Discard any unused portion

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 70860-453-10

Levothyroxine Sodium for Injection

500 mcg per vial

Rx only

For Intravenous Use

Single-Dose Vial

Discard any unused portion

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
(click image for full-size original)
LEVOTHYROXINE SODIUM levothyroxine sodium anhydrous injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70860-451
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
levothyroxine sodium anhydrous (levothyroxine) levothyroxine sodium anhydrous 100 ug in 5 mL
Inactive Ingredients
Ingredient Name Strength
mannitol
sodium phosphate, dibasic, heptahydrate
sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70860-451-10 1 VIAL in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON (70860-451-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208749 12/15/2018
LEVOTHYROXINE SODIUM levothyroxine sodium anhydrous injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70860-452
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
levothyroxine sodium anhydrous (levothyroxine) levothyroxine sodium anhydrous 200 ug in 5 mL
Inactive Ingredients
Ingredient Name Strength
mannitol
sodium phosphate, dibasic, heptahydrate
sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70860-452-10 1 VIAL in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON (70860-452-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208749 12/15/2018
LEVOTHYROXINE SODIUM levothyroxine sodium anhydrous injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70860-453
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
levothyroxine sodium anhydrous (levothyroxine) levothyroxine sodium anhydrous 500 ug in 5 mL
Inactive Ingredients
Ingredient Name Strength
mannitol
sodium phosphate, dibasic, heptahydrate
sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70860-453-10 1 VIAL in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON (70860-453-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208749 12/15/2018
Labeler — Athenex Pharmaceutical Division, LLC. (080318964)

Revised: 12/2018 Athenex Pharmaceutical Division, LLC.

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