BIVALIRUDIN (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Bivalirudin for injection is supplied as a sterile, white to off white lyophilized cake or 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.

250 mg per vial:

Single-Dose Vials

in a carton of 10 NDC 55150-210-10

16.2 Storage

Store bivalirudin dosage units at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Discard unused portion.
The vial stoppers are 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.

All brands listed are the trademarks of their respective owners and are not trademarks of Eugia Pharma Specialities Limited.

Distributed by:
AuroMedics Pharma LLC
279 Princeton-Hightstown Rd.
E. Windsor, NJ 08520

Manufactured by:
Eugia Pharma Specialities Limited
Hyderabad — 500032
India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 250 mg per vial — Container Label

Rx only NDC 55150-210-10
Bivalirudin
for Injection
250 mg per vial
For Intravenous Use Only
For Single-Dose Only
Discard unused portion

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 250 mg per vial -- Container Label
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 250 mg per vial — Container-Carton (10 Vials)

Rx only NDC 55150-210-10
Bivalirudin
for Injection
250 mg per vial
For Intravenous Use Only
10 Single-Dose Vials
AUROMEDICS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 250 mg per vial -- Container-Carton (10 Vials)
(click image for full-size original)

BIVALIRUDIN bivalirudin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55150-210
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:55150-210-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55150-210-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205962 07/27/2018
Labeler — Eugia US LLC (968961354)
Establishment
Name Address ID/FEI Operations
Eugia Pharma Specialities Limited 650498244 ANALYSIS (55150-210), MANUFACTURE (55150-210), PACK (55150-210)

Revised: 08/2023 Eugia US LLC

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