Dacarbazine (Page 2 of 2)

HOW SUPPLIED

DACARBAZINE FOR INJECTION, USP is available in the following forms:

Product Code	Unit of Sale	Strength	Each
102710	NDC 63323-127-10 Unit of 10	100 mg	NDC 63323-127-00 10 mL Single Dose Vial
102820	NDC 63323-128-20 Unit of 10	200 mg	NDC 63323-128-00 20 mL Single Dose Vial

STORE IN A REFRIGERATOR 2°-8°C (36°-46°F).

PROTECT FROM LIGHT.

USE WITHIN 8 HOURS OF RECONSTITUTION.

Vial stoppers do not contain natural rubber latex.

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, D.C. 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.

www.fresenius-kabi.com/us

45650D

Revised: July 2022

PACKAGE LABEL — PRINCIPAL DISPLAY – Dacarbazine 100 mg Vial Label

NDC 63323-127-00 102710

DACARBAZINE

FOR INJECTION, USP

100 mg

prepared as the

citrate salt

For IV Use Only

Single Dose Vial Rx only

Discard Unused Portion

PACKAGE LABEL — PRINCIPAL DISPLAY — Dacarbazine 100 mg Tray Label

NDC 63323-127-10 102710

DACARBAZINE

FOR INJECTION, USP

100 mg

prepared as the

citrate salt

For IV Use Only

10 x 10 mL

Single Dose Vials Rx only

Discard Unused Portion

PACKAGE LABEL — PRINCIPAL DISPLAY – Dacarbazine 200 mg Vial Label

NDC 63323-128-00 102820

DACARBAZINE

FOR INJECTION, USP

200 mg

prepared as the citrate salt

For IV Use Only

Single Dose Vial Rx only

Discard Unused Portion

PACKAGE LABEL — PRINCIPAL DISPLAY – Dacarbazine 200 mg Tray Label

NDC 63323-128-20 102820

DACARBAZINE

FOR INJECTION, USP

200 mg

prepared as the citrate salt

For IV Use Only

10 x 20 mL

Single Dose Vial Rx only

Discard Unused Portion

DACARBAZINE dacarbazine injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-127 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DACARBAZINE (DACARBAZINE) DACARBAZINE 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE 10 mg in 1 mL MANNITOL 5 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63323-127-10 10 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (63323-127-00) 1 NDC:63323-127-00 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (63323-127-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075371 09/07/2001

DACARBAZINE dacarbazine injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-128 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DACARBAZINE (DACARBAZINE) DACARBAZINE 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE 10 mg in 1 mL MANNITOL 3.75 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63323-128-20 10 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (63323-128-00) 1 NDC:63323-128-00 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (63323-128-20)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075371 09/07/2001

Labeler — Fresenius Kabi USA, LLC (608775388)

Establishment
Name	Address	ID/FEI	Operations
Fresenius Kabi USA, LLC		023648251	manufacture (63323-127), manufacture (63323-128)

Revised: 10/2022 Fresenius Kabi USA, LLC