CEFAZOLIN (Page 3 of 3)


Preparation of Parenteral Solution
Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

When reconstituted or diluted according to the instructions below, Cefazolin for Injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

Single-Dose VialsFor IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

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Intramuscular Administration
Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection.

Intravenous Administration Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of 1 of the following solutions:

Sodium Chloride Injection, USP

  • 5% or 10% Dextrose Injection, USP
  • 5% Dextrose in Lactated Ringer’s Injection, USP
  • 5% Dextrose and 0.9% Sodium Chloride Injection, USP
  • 5% Dextrose and 0.45% Sodium Chloride Injection, USP
  • 5% Dextrose and 0.2% Sodium Chloride Injection, USP
  • Lactated Ringer’s Injection, USP
  • Invert Sugar 5% or 10% in Sterile Water for Injection
  • Ringer’s Injection, USP
  • 5% Sodium Bicarbonate Injection, USP

How Supplied

Cefazolin for Injection, USP is supplied in vials containing cefazolin sodium equivalent to 500 mg or 1 gram cefazolin.

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Also available as Pharmacy Bulk Package, as follows:

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As with other cephalosporins, Cefazolin for Injection, USP tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected.

Before reconstitution protect from light and store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Product repackaged by: Henry Schein, Inc., Bastian, VA 24314
From Original Manufacturer/Distributor’s NDC and Unit of SaleTo Henry Schein Repackaged Product NDC and Unit of SaleTotal Strength/Total Volume (Concentration) per unit
NDC 0143-9923-90Carton of 25 vialsNDC 0404-9835-991 10 mL vial in a bag(Vial bears NDC 0143-9923-90)

500 mg

NDC 0143-9924-90Carton of 25 vialsNDC 0404-9834-991 10 mL vial in a bag(Vial bears NDC 0143-9924-90)1 gram

CLINITEST is a registered trademark of Miles, Inc.
CLINISTIX is a registered trademark of Bayer Corporation.

Manufactured by:
Estrada do Rio da Mó, 8, 8A e 8B – Fervença
2705-906 Terrugem SNT PORTUGAL

Distributed by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922

Revised: June 2020PIN001-WES/8

Sample Package Label

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CEFAZOLIN cefazolin injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-9834(NDC:0143-9924)
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
# Item Code Package Description Multilevel Packaging
1 NDC:0404-9834-99 1 VIAL in 1 BAG contains a VIAL
1 3 mL in 1 VIAL This package is contained within the BAG (0404-9834-99)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065047 01/09/2022
Labeler — Henry Schein, Inc. (012430880)
Name Address ID/FEI Operations
Henry Schein, Inc. 830995189 relabel (0404-9834)

Revised: 01/2023 Henry Schein, Inc.

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