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Heparin: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current since November 3, 2026
Strength:
5000 USP units/mL
Active ingredient:

Patient information: uses, side effects, how to take - Heparin

INSTRUCTIONS FOR USE

Figure 1: Outer Packaging and Prefilled Syringe

NOTES:

  • Do not introduce any other fluid into the syringe at any time.
  • Do not dilute for IV push.
  • Do not re-sterilize the syringe.
  • Do not use this product on a sterile field.
  • This product is for single-dose only.
  • Inspect the outer packaging (blister pack) to confirm the integrity of the packaging. Do not use if the blister pack or the prefilled syringe has been damaged.
  • Remove the syringe from the outer packaging. (See Figure 2)
  • Figure 2
  • Visually inspect the syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Twist off the syringe tip cap. Do not remove the label around the luer lock collar. (See Figure 3)
  • Figure 3
  • Expel air bubble(s). Adjust the dose (if applicable).
  • Administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration.
  • Discard the used syringe into an appropriate receptacle.

For more information concerning this drug, please call Fresenius Kabi USA, LLC at 1-800-551-7176.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The brand names mentioned in this document are the trademarks of their respective owners.

This “Instructions for Use” has been approved by the U.S. Food and Drug Administration. Revised: November 2020

Lake Zurich, IL 60047

www.fresenius-kabi.com/us

451593

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 206552 · View the label on DailyMed

Revision date stated in the text: November 2020

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Heparin

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 5000 USP units/mL
Dosage form Injection, solution
Route Intravenous, Subcutaneous
Marketing status listed in the FDA NDC Directory
Company (applicant) FRESENIUS KABI USA
FDA approval ANDA 206552Abbreviated New Drug Application (ANDA) – generic drug Approved June 10, 2016
Therapeutic equivalence (TE) code APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 18 labelers list this drug on DailyMed
Drug shortage
  • Current since November 3, 2026
Recalls
  • October 1, 2026: Class II recall: Lack of Assurance of Sterility
Packages (NDC)
Package
5000 USP units/mL – 1 ml in 1 syringe, glass / 1 in 1 blister pack / 24 in 1 carton NDC 76045-108-00

Source: FDA drug labeling via NLM DailyMed, data as of November 7, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.