Dacarbazine (Page 2 of 2)

HOW SUPPLIED

Sterile Dacarbazine for Injection, USP is available as follows:

NDC Number Concentration Package Size
0703-5075-01 200 mg 20 mL single-dose vial,
packaged individually
0703-5075-03 200 mg 20 mL single-dose vials,
10 per package

Store in a refrigerator 2° to 8°C (36° to 46°F). Use within 8 hours of reconstitution. Protect from light.

Discard Unused Portion.

REFERENCES

  1. Loo, T.J., et al.: Mechanism of action and pharmacology studies with DTIC (NSC-45388). Cancer Treatment Reports 60: 149–152, 1976.
  2. Nathanson, L., et al.: Characteristics of prognosis and response to an imidazole carboxamide in malignant melanoma. Clinical Pharmacology and Therapeutics 12: 955–962, 1971.
  3. Costanza, M.E., et al.: Therapy of malignant melanoma with an imidazole carboxamide and bischloroethyl nitrosourea. Cancer 30: 1457–1461, 1972.
  4. Luce, J.K., et al.: Clinical trials with the antitumor agent 5-(3, 3-dimethyl-1-triazeno) imidazole-4-carboxamide (NSC-45388). Cancer Chemotherapy Reports 54: 119–124, 1970.
  5. Bonadonna, G., et al.: Combined Chemotherapy (MOPP or ABVD)—radiotherapy approach in advanced Hodgkin’s disease. Cancer Treatment Reports 61: 769–777, 1977.
  6. Santoro, A., and Bonadonna, G.: Prolonged disease-free survival in MOPP-resistant Hodgkin’s disease after treatment with adriamycin, bleomycin, vinblastine and dacarbazine (ABVD).
    Cancer Chemotherapy Pharmacol. 2: 101–105, 1979.
  7. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.
  8. AMA Council Report, Guidelines for Handling Parenteral Antineoplastics, JAMA , 1985; 253 (11):1590–1592.
  9. 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.
  10. Clinical Oncological Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med. J. Australia , 1983; 1:426–428.
  11. Jones, RB, et al.: Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA—A Cancer Journal for Clinicians, 1983; (Sept/Oct) 258–263.
  12. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am. J. Hosp. Pharm , 1990; 47: 1033–1049.
  13. OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs. Am. J. Hosp. Pharm , 1986; 43:1193–1204.

Distributed by:
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054

Rev. B 2/2020

Package/Label Display Panel

NDC 0703-5075-01

Rx only

Dacarbazine for Injection, USP

200 mg

Prepared as the citrate salt

For Intravenous Use Only

Single-Dose Vial

Discard Unused Portion.

Carton
(click image for full-size original)

DACARBAZINE
dacarbazine injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-5075
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DACARBAZINE (DACARBAZINE) DACARBAZINE 200 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
MANNITOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0703-5075-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0703-5075-01)
2 NDC:0703-5075-03 10 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE
2 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0703-5075-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075259 08/27/1998 05/31/2024
Labeler — Teva Parenteral Medicines, Inc. (794362533)

Revised: 02/2020 Teva Parenteral Medicines, Inc.

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