Etoposide (Page 4 of 4)

REFERENCES

1.
Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.
2.
AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA 1985 March 15.
3.
National Study Commission on Cytotoxic Exposure — Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
4.
Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia 1:426-428, 1983.
5.
Jones RB, et al. Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center. CA — A Cancer Journal for Clinicians (Sept/Oct):258–263, 1983.
6.
American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm 47:1033–1049, 1990.
7.
Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines). Am J Health-Syst Pharm 53:1669–1685, 1996.

Manufactured By:
Intas Pharmaceuticals Limited,
Plot No.: 457, 458, Village – Matoda, Bavla Road,
Ta.- Sanand, Dist.-Ahmedabad – 382 210, India.
For BluePoint Laboratories
Issued November, 2014

Package/Label Display Panel

Etoposide Injection USP, 5 mL Multiple Dose Vial – Vial Label

100 mg/5 mL (20 mg/mL), NDC 68001-265-22

Etoposide Inj Vial Label.jpg
(click image for full-size original)

Package/Label Display Panel

Etoposide Injection USP, 5 mL Multiple Dose Vial – Carton Label

100 mg/5 mL (20 mg/mL), NDC 68001-265-25

Etoposide Inj Carton 100mg_5ml (20mg_ml)  Rev 05 2018.JPG
(click image for full-size original)
ETOPOSIDE
etoposide injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-265
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETOPOSIDE (ETOPOSIDE) ETOPOSIDE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL 0.305 mL in 1 mL
BENZYL ALCOHOL 30 mg in 1 mL
ANHYDROUS CITRIC ACID 2 mg in 1 mL
POLYSORBATE 80 80 mg in 1 mL
POLYETHYLENE GLYCOL 300 650 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-265-25 1 VIAL, MULTI-DOSE in 1 BOX contains a VIAL, MULTI-DOSE (68001-265-22)
1 NDC:68001-265-22 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the BOX (68001-265-25)
2 NDC:68001-265-26 1 VIAL, MULTI-DOSE in 1 BOX contains a VIAL, MULTI-DOSE (68001-265-23)
2 NDC:68001-265-23 25 mL in 1 VIAL, MULTI-DOSE This package is contained within the BOX (68001-265-26)
3 NDC:68001-265-27 1 VIAL, MULTI-DOSE in 1 BOX contains a VIAL, MULTI-DOSE (68001-265-24)
3 NDC:68001-265-24 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the BOX (68001-265-27)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074513 11/14/2013
Labeler — BluePoint Laboratories (985523874)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Ltd 725927649 MANUFACTURE (68001-265), ANALYSIS (68001-265)

Revised: 06/2018 BluePoint Laboratories

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.