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-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
BIVALIRUDIN bivalirudin injection, powder, lyophilized, for solution | |||||||||||||||||
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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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