Bivalirudin (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Bivalirudin for Injection is supplied as follows:

NDC Bivalirudin for Injection Package Factor
70860-402-10 250 mg Single-Dose Vial 10 vials per carton

Bivalirudin for Injection is a sterile, lyophilized powder in single-dose, glass vials. Each vial contains 250 mg of bivalirudin equivalent to an average of 275 mg of bivalirudin trifluoroacetate*.

*The range of bivalirudin trifluoroacetate is 270 to 280 mg based on a range of trifluoroacetic acid composition of 1.9 to 2.6 equivalents.

16.2 Storage

Storage Conditions

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]

Discard unused portion.

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

17 PATIENT COUNSELING INFORMATION

Advise patients to watch carefully for any signs of bleeding or bruising and to report these to their health care provider when they occur.

Athenex
Mfd. for Athenex
Schaumburg, IL 60173 (USA)
Made in China
©2019 Athenex.

July 2019

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — VIAL LABEL

NDC 70860-402-41

Bivalirudin for Injection

250 mg per vial

For Intravenous Use Only

Single-Dose Vial

Discard unused portion

Rx only

PACKAGE LABEL -- PRINCIPAL DISPLAY PANEL -- VIAL LABEL
(click image for full-size original)
BIVALIRUDIN
bivalirudin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70860-402
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
bivalirudin (bivalirudin) bivalirudin 250 mg
Inactive Ingredients
Ingredient Name Strength
mannitol
sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70860-402-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (70860-402-41)
1 NDC:70860-402-41 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70860-402-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210031 11/30/2019
Labeler — Athenex Pharmaceutical Division, LLC. (080318964)

Revised: 09/2019 Athenex Pharmaceutical Division, LLC.

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