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Cefprozil how supplied

Introduction

Cefprozil
CEFZIL®,CEFPROZIL® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
Clinical Studies
How Supplied
Labels and Packages

Cefprozil Tablets USP, 250 mg are oval-shaped, white to cream tinged, unscored, film-coated tablets, debossed 347 on one side and 250 on the reverse side and are supplied as follows:

NDC 0781-5043-01 in bottles of 100 tablets

Ceprozil Tablets USP, 500 mg are oval-shaped, beige, unscored, film-coated tablets, debossed 348 on one side and 500 on the reverse side and are supplied as follows:

NDC 0781-5044-50 in bottles of 50 tablets

NDC 0781-5044-01 in bottles of 100 tablets

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

Dispense in a tight, light-resistant container as defined in the USP.

Cefprozil for Oral Suspension, USP, 125 mg/5 mL is supplied as follows:

NDC 0781-6202-91 50 mL bottle

NDC 0781-6202-57 75 mL bottle

NDC 0781-6202-46 100 mL bottle

Cefprozil for Oral Suspension, USP, 250 mg/5 mL is supplied as follows:

NDC 0781-6203-91 50 mL bottle

NDC 0781-6203-57 75 mL bottle

NDC 0781-6203-46 100 mL bottle

All powder formulations for oral suspension contain cefprozil in a fruity flavored mixture. Cefprozil powder is slightly cream tinged to beige. After reconstitution the suspension is light orange and of a fruity odor and flavor.

References

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]