Cefizox (Page 6 of 6)

HOW SUPPLIED

Cefizox^® (ceftizoxime for injection, USP)

NDC 0469­7250­01 Product No. 725001

Equivalent to 500 mg ceftizoxime in 10 mL, single­dose, flip­top vials, individually

packaged

NDC 0469­7251­01 Product No. 725101

Equivalent to 1 gram ceftizoxime in 20 mL, single­dose, flip­top vials, individually

packaged

NDC 0469­7252­01 Product No. 725201

Equivalent to 1 gram ceftizoxime in 100 mL, single­dose, Piggyback, flip­top vials, packaged in tens

NDC 0469­7253­02 Product No. 725302

Equivalent to 2 grams ceftizoxime in 20 mL, single­dose, flip­top vials, individually packaged

NDC 0469­7254­02 Product No. 725402

Equivalent to 2 grams ceftizoxime in 100 mL, single­dose, Piggyback, flip­top vials, packaged in tens

Unreconstituted Cefizox should be protected from excessive light, and stored at controlled room temperature (59º­86ºF) in the original package until used.

Rx only

REFERENCES

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol. 20, No. 2, NCCLS, Wayne, PA, January 2000.
2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests – Seventh Edition. Approved Standard NCCLS Document M2-A7, Vol. 20, No. 1, NCCLS, Wayne, PA, January 2000.
3. National Committee for Clinical Laboratory Standards. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria – Fourth Edition. Approved Standard NCCLS Document M11-A4, Vol. 17, No. 22, NCCLS, Wayne, PA, December 1997.
4. National Committee for Clinical Laboratory Standards. MIC Testing Supplemental Tables. NCCLS Document M100-S10 (M7), NCCLS, Wayne, PA, January 2000.

Product of Japan

Manufactured for:

Fujisawa Healthcare, Inc.

Deerfield, IL 60015-2548

CEFIZOX ceftizoxime sodium injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0469-7250 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ceftizoxime sodium (ceftizoxime) ceftizoxime 500 mg

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0469-7250-01 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1 VIAL) in 1 VIAL None

CEFIZOX ceftizoxime sodium injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0469-7251 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ceftizoxime sodium (ceftizoxime) ceftizoxime 1 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0469-7251-01 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1 VIAL) in 1 VIAL None

CEFIZOX ceftizoxime sodium injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0469-7253 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ceftizoxime sodium (ceftizoxime) ceftizoxime 2 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0469-7253-02 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1 VIAL) in 1 VIAL None

CEFIZOX ceftizoxime sodium injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0469-7252 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ceftizoxime sodium (ceftizoxime) ceftizoxime 1 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0469-7252-01 10 VIAL, PIGGYBACK (10 VIAL) in 1 PACKAGE contains a VIAL, PIGGYBACK 1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1 VIAL) in 1 VIAL, PIGGYBACK This package is contained within the PACKAGE (0469-7252-01)

CEFIZOX ceftizoxime sodium injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0469-7254 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ceftizoxime sodium (ceftizoxime) ceftizoxime 2 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0469-7254-02 10 VIAL, PIGGYBACK (10 VIAL) in 1 PACKAGE contains a VIAL, PIGGYBACK 1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1 VIAL) in 1 VIAL, PIGGYBACK This package is contained within the PACKAGE (0469-7254-02)

Labeler — Fujisawa Healthcare, Inc.

Revised: 08/2007 Fujisawa Healthcare, Inc.