Bivalirudin (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Bivalirudin for injection is supplied as 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 1.7 to 2.6 equivalents.

NDC 0781-9158-95 – Package of 10 – 250 mg Single-Dose Vials

16.2 Storage

Store Bivalirudin dosage units at 20° to 25°C (68° to 77°F); excursions to 15° to 30°C permitted [see USP Controlled Room Temperature].

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.

Distributed by:

Sandoz Inc.

Princeton, NJ 08540

U.S. Patents 7,598,343; 7,582,727

novaplus_logo

Novaplus is a registered trademark of Vizient, Inc.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0781-9158-95

Bivalirudin for Injection

For Intravenous Use Only

10 Single-Dose Vials

Rx Only

Discard unused portion.

250 mg

carton_10ct
(click image for full-size original)
BIVALIRUDIN
bivalirudin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-9158
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:0781-9158-95 10 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (0781-9158-94)
1 NDC:0781-9158-94 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0781-9158-95)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020873 10/23/2015
Labeler — Sandoz Inc (005387188)

Revised: 09/2019 Sandoz Inc

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