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Heparin Sodium, injection, solution Package Insert

Updated:
Facts
Status:
Prescription (Rx)
Strength:
100 USP units/mL
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Heparin Sodium, injection, solution

• WARNINGS AND PRECAUTIONS

Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.

• ADVERSE EVENTS

To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.

• HOW SUPPLIED

Contains 25,000 USP Units of Heparin Sodium in 0.45% Sodium Chloride in a 250 mL Single-Dose Bag. Volume & Concentration exlude additive & manufacturer overfill.

This product is Sterile, Nonpyrogenic, and Latex Free.

• INGREDIENTS

Each 1 mL contains contains Heparin Sodium 100 USP Units, Sodium Chloride 4.5 mg, Benzyl Alcohol 0.0002 mL. May contain Hydrochloric Acid and/or Sodium Hydroxide for pH adjustment.

• STORAGE AND HANDLING

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

• DOSAGE AND ADMINISTRATION.

FOR INTRAVENOUS USE.

Rx Only

Rev. 05/15

CANTRELL DRUG COMPANY

LITTLE ROCK, AR 72207

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

Revision date stated in the text: May 2015

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Drug information for Heparin Sodium, injection, solution

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Anti-coagulant, Unfractionated Heparin
Active ingredient Heparin sodium 100 USP units/mL
Dosage form Injection, solution
Route Intravenous
Marketing status not in the current FDA NDC Directory
Company (applicant) Cantrell Drug Company
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
100 USP units/mL – 250 ml in 1 bag NDC 52533-179-18

Source: FDA drug labeling via NLM DailyMed, data as of November 2, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.