Cytarabine (Page 4 of 4)

STORAGE CONDITIONS

Protect from light. Retain in carton until time of use.

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

REFERENCES

  1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publications No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
  2. AMA Council Report, Guidelines for Handling Parenteral Antineoplastics, JAMA, 1985; 2.53 (11): 1590–1592.
  3. National Study Commission on Cytotoxic Exposure – Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD., 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, 1983; 1:426–428.
  5. Jones RB, et al: Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA-A Cancer Journal of Clinicians, 1983; (Sept/Oct) 258–263.
  6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J. Hosp. Pharm, 1990; 47:1033–1049.
  7. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work Practice Guidelines), Am J. Health- Syst Pharm, 1996; 53:1669–1685.

Hospira Logo

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

GUJ-DRUGS/G/28/1267

LAB-1173-2.0

Revision: 6/2020

PRINCIPAL DISPLAY PANEL — 5 mL Vial Label

5 mL Vial
NDC 61703-305-58

Cytarabine Injection

100 mg/5 mL
(20 mg/mL)
Rx only

For Intravenous, Intrathecal and Subcutaneous Use Only

Single Dose Vial
Cytotoxic Agent

LOT
EXP

PRINCIPAL DISPLAY PANEL -- 5 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mL Vial Carton

VIAL

Hospira

5 x 5 mL Vials
NDC 61703-305-38

Sterile
Contains 5 of NDC 61703-305-58

Cytarabine Injection 100 mg/ 5 mL
(20 mg/mL)

Rx only

For Intravenous, Intrathecal and Subcutaneous Use Only
Single Dose Vials

Cytotoxic Agent

PRINCIPAL DISPLAY PANEL -- 5 mL Vial Carton
(click image for full-size original)
CYTARABINE
cytarabine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61703-305
Route of Administration INTRAVENOUS, INTRATHECAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYTARABINE (CYTARABINE) CYTARABINE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 6.8 mg in 1 mL
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61703-305-38 5 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (61703-305-58)
1 NDC:61703-305-58 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (61703-305-38)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071868 06/04/1990
Labeler — Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Hospira Australia Pty Ltd 758967652 ANALYSIS (61703-305), MANUFACTURE (61703-305), PACK (61703-305), LABEL (61703-305)
Establishment
Name Address ID/FEI Operations
Zydus Hospira Oncology Private Limited 676190889 ANALYSIS (61703-305), MANUFACTURE (61703-305), PACK (61703-305), LABEL (61703-305)

Revised: 06/2021 Hospira, Inc.

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