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Prescription medicine · generic available

Heparin sodium

Brand names: Heparin Sodium and Dextrose

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
Current shortageFDA shortage list
10Recalls (FDA reports)
24Companies
1972First FDA approval on file

Quick answers

What is Heparin sodium used for?
The FDA-approved label (Heparin Sodium, Cardinal Health 107, LLC, August 10, 2026) says: “Heparin Sodium Injection is indicated for: • Prophylaxis and treatment of venous thrombosis and pulmonary embolism; • Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; • Atrial fibrillation with embolization …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Heparin sodium have a boxed warning?
No. None of the 58 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Heparin sodium?
The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
Has Heparin sodium been recalled?
FDA enforcement reports list 10 recalls of products of this medicine; the newest started August 1, 2024 (Class I). A recall usually concerns specific lots, not every product.
Who makes Heparin sodium?
24 companies list prescription products of Heparin sodium in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Meitheal Pharmaceuticals Inc. and Hospira, Inc..

What Heparin sodium is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Heparin Sodium Injection is indicated for: • Prophylaxis and treatment of venous thrombosis and pulmonary embolism; • Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; • Atrial fibrillation with embolization …

— FDA label: Heparin Sodium, Cardinal Health 107, LLC, effective August 10, 2026. Read the full label on DailyMed →

The FDA has 58 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Atrial fibrillationDeep vein thrombosis

Related medical specialties

Cardiology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 58 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, solution · Injection
RouteIntravenous · Subcutaneous
Prescription products117 in the FDA NDC Directory
Brand namesHeparin Sodium and Dextrose

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Heparin sodium, by strength and form
Strength and formGeneric or brandPharmacies pay
heparin sodium 10000 USP units/mL
injection		 Generic $2.20 per mL
heparin sodium 10000 USP units/mL
injection, solution		 Generic $2.20 per mL
heparin sodium 5000 USP units/0.5 mL
injection, solution		 Generic $5.90 per mL
heparin sodium 5000 USP units/mL
injection		 Generic $1.22 per mL
heparin sodium 5000 USP units/mL
injection, solution		 Generic $1.22–$3.19 per mL
10 packages, lowest to highest

NADAC list of November 4, 2026; these prices took effect between May 20, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA017029
HEPARIN SODIUM, HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%, HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%, HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%, HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM PRESERVATIVE FREE		 Fresenius Kabi USAFebruary 22, 1972 76, latest October 24, 2024
2024: Labeling · 2021: Labeling · 2020: Labeling
NDA017037
HEPARIN SODIUM		 HikmaMarch 22, 1972 118, latest October 24, 2024
2024: Labeling · 2020: Manufacturing (CMC) · 2019: Manufacturing (CMC)
NDA017651
HEPARIN SODIUM		 Fresenius Kabi USAFebruary 10, 1978 44, latest October 24, 2024
2024: Labeling · 2021: Labeling · 2020: Labeling
NDA018609
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER		 Baxter HlthcareApril 28, 1982 38, latest January 3, 2022
2022: Labeling · 2019: Labeling · 2016: Manufacturing (CMC)
NDA018916
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%, HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%, HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%, HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER		 HospiraJanuary 31, 1984 41, latest November 19, 2025
2025: Labeling · 2024: Labeling · 2024: Labeling
NDA019339
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER		 HospiraMarch 27, 1985 30, latest February 7, 2024
2024: Labeling · 2019: Labeling · 2018: Labeling
NDA019953
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER		 B BraunJuly 20, 1992 20, latest October 26, 2026
2026: Labeling · 2025: Labeling · 2023: Labeling
NDA201370
HEPARIN SODIUM, HEPARIN SODIUM PRESERVATIVE FREE		 PfizerJuly 21, 2011 10, latest September 24, 2025
2025: Labeling · 2024: Labeling · 2019: Labeling

Generic approvals (21)

Shortage status

Current shortage · updated October 21, 2026 · first posted November 14, 2017

ProductHeparin Sodium, Injection, 1,000 Units/500 mL (2 Units/mL) (NDC 0409-1005-20)
AvailabilityAvailable
CompanyHospira, Inc., a Pfizer Company

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. August 1, 2024 · Class I · Ongoing · D-0649-2024

    Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

    Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04 — Baxter Healthcare Corporation

  2. February 28, 2023 · Class II · Terminated · D-0435-2023

    Labeling: Not elsewhere classified

    Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-4 — Sagent Pharmaceuticals Inc

  3. December 29, 2022 · Class II · Completed · D-0097-2023

    Lack of assurance of sterility: Bags have the potential to leak.

    Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake — Pfizer Inc.

  4. June 3, 2015 · Class II · Terminated · D-1131-2015

    Subpotent Drug; out of specification results for heparin raw material

    Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03 — Baxter Healthcare Corp

  5. October 30, 2014 · Class II · Terminated · D-0276-2015

    Subpotent Drug: Heparin raw material was found to have low potency

    Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015 by Baxter Hea — Baxter Healthcare Corp.

  6. September 11, 2014 · Class I · Terminated · D-0324-2015

    Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.

    HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03 — Hospira Inc.

  7. June 6, 2014 · Class II · Terminated · D-1425-2014

    Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.

    Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62 — Hospira Inc.

  8. January 22, 2014 · Class II · Terminated · D-1148-2014

    Subpotent; 18 month time point

    Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium In — Fresenius Kabi USA, LLC

  9. January 9, 2014 · Class II · Terminated · D-1036-2014

    Lack of Assurance of Sterility; potential leakage from administrative port.

    Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59. — Hospira Inc.

  10. May 21, 2013 · Class II · Terminated · D-626-2013

    Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

    Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0 — Baxter Healthcare Corp.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)1361226, 1361574, 1361615, 1361853, 1362831, 1658634, 1658637, 1658647, 1658659, 1658690 … (+10)
SPL set ID of the quoted label239b4816-6a55-451b-bf40-e611be07d12f
FDA labels (SPL)58
FDA applicationsNDA017029, NDA017037, NDA017651, NDA018609, NDA018916, NDA019339, NDA019953, NDA201370, 21 ANDA
Active ingredients (FDA)HEPARIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Heparin Sodium, Cardinal Health 107, LLC, effective August 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers