Prescription medicine
Heparin
Heparin is a prescription medicine with an FDA approval on record since 1939. FDA's NDC Directory lists it from 18 generic labelers, and pharmacies paid $1.18 per mL (Heparin sodium 5,000 unit/mL vial) in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
Check it at the source: the heparin FDA label on DailyMed (effective November 28, 2025, Fresenius Kabi USA, LLC); the NDA 552 record on Drugs@FDA; every heparin label on DailyMed.
Highlights of the record
FDA label of November 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageHeparin Sodium Injection is indicated for: Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension;
Forms and strengths
- 0.5ml
- 100ml
- 2ml
Injection (solution); injection.
On the market
- Earliest approval on file
- February 9, 1939 Heparin Sodium, Aspen Global Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 33 first March 13, 1979; 23 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 25 of which 18 under generic applications, 12 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.18 per mL Heparin sodium 5,000 unit/mL vial
- Shortage (FDA)
- 3 of 8 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 18 since 2013 3 Class I among all firms' recalls; latest August 1, 2024; 6 more by firms not listed as its makers
- FAERS reports
- 13,673 through July 30, 2026
What is heparin used for?
From the label: indications and usageHeparin Sodium Injection is indicated for: Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; Low-dose regimen for 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 (see DOSAGE AND ADMINISTRATION ); Prophylaxis and treatment of pulmonary embolism; Atrial fibrillation with embolization; Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); Prevention of clotting in arterial and cardiac surgery; Prophylaxis and treatment of peripheral arterial embolism. […]
Conditions named in the indications of heparin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Anti-coagulant and Unfractionated Heparin.
Source: FDA drug label (Heparin Sodium), Fresenius Kabi USA, LLC, effective November 28, 2025 (SPL set d55b4a63-0c04-4874-b74f-9e9b9e8b008c), via openFDA; the full label on DailyMed
Is there a generic for heparin?
The FDA approved the first generic heparin on March 13, 1979. 33 generic applications are approved; 23 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists heparin from 18 labelers under a generic (ANDA) application and from 12 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1939 earliest approval on file
- 1979 first generic approved
- 2017 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for heparin?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.18 per mL (Heparin sodium 5,000 unit/mL vial), up 9% from $1.08 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Heparin sodium 5,000 unit/mL vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Heparin sod 10,000 unit/mL vial | Generic | $2.09 per mL | n/a | n/a |
| Heparin sod 5,000 unit/mL syrg | Generic | $3.19 per mL | n/a | -11% |
| Heparin sod 5,000 unit/mL vial | Generic | $1.18 per mL | n/a | n/a |
| Heparin sodium 10,000 unit/mL vial | Generic | $2.09 per mL | n/a | -12% |
| Heparin sodium 5,000 unit/0.5 mL syringe | Generic | $5.90 per mL | $2.95 per single-dose syringe | -10% |
| Heparin sodium 5,000 unit/mL vial | Generic | $1.18 per mL | n/a | +9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is heparin in shortage?
The FDA Drug Shortage Database lists 3 of 8 heparin presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on November 14, 2017. 5 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container, Injection, 200 [USP'U]/100 mL (NDC 0264-9872-10) | B. Braun Medical Inc. | Current | September 22, 2026 |
| Heparin Sodium 2,000 Units in Sodium Chloride 0.9% in Plastic Container, Injection, 200 [USP'U]/100 mL (NDC 0264-9872-00) | B. Braun Medical Inc. | Current | September 22, 2026 |
| Heparin Sodium In Sodium Chloride, Injection, 200 [USP'U]/100 mL (NDC 0338-0431-03) | Baxter Healthcare | Current | October 2, 2026 |
| Heparin Sodium In Sodium Chloride, Injection, 200 [USP'U]/100 mL (NDC 0338-0433-04) | Baxter Healthcare | Current | October 2, 2026 |
| Heparin Sodium, Injection, 1,000 Units/500 mL (2 Units/mL) (NDC 0409-1005-20) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Heparin Sodium, Injection, 2,000 Units/1,000 mL (2 Units/mL) (NDC 0409-2222-12) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Heparin Sodium, Injection, 200 [USP'U]/100 mL (NDC 63323-519-10) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Heparin Sodium, Injection, 200 [USP'U]/100 mL (NDC 63323-519-77) | Fresenius Kabi USA, LLC | Current | September 15, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has heparin been recalled?
The FDA's Enforcement Report lists 24 recalls naming heparin since 2013: 3 Class I (the most serious), 21 Class II, 0 Class III; 1 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of heparin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 1, 2024 | Class I | Baxter Healthcare Corporation | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. |
| July 14, 2023 | Class II | Central Admixture Pharmacy Services, Inc. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. |
| February 28, 2023 | Class II | Sagent Pharmaceuticals Inc | Labeling: Not elsewhere classified |
| December 29, 2022 | Class II | Pfizer Inc. | Lack of assurance of sterility: Bags have the potential to leak. |
| April 2, 2019 | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderson … not a listed maker | Lack of sterility assurance. |
| March 13, 2019 | Class II | Advanced Pharma Inc. | Lack of Assurance of Sterility |
| November 18, 2016 | Class II | Cantrell Drug Company | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. |
| November 10, 2015 | Class II | Walgreens Infusion Services not a listed maker | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the heparin label say about other medicines?
The heparin label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 40 other medicines name heparin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Andexanet alfa | drug interactions | Andexanet alfa may reduce the efficacy of heparin when used concomitantly |
| Apixaban | drug interactions | Avoid use of heparin after use of andexanet alfa for the reversal of direct Factor Xa inhibitors (apixaban and rivaroxaban). |
| Celecoxib | drug interactions | Drugs such as NSAIDS (including salicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIb/IIIa antagonists (including abciximab, eptifibatide, and tirofiban), and others that interfere with platelet-aggregation reactions (the … |
| Dipyridamole | drug interactions | Drugs such as NSAIDS (including salicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIb/IIIa antagonists (including abciximab, eptifibatide, and tirofiban), and others that interfere with platelet-aggregation reactions (the … |
| Eptifibatide | drug interactions | Drugs such as NSAIDS (including salicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIb/IIIa antagonists (including abciximab, eptifibatide, and tirofiban), and others that interfere with platelet-aggregation reactions (the … |
| Hydroxychloroquine | drug interactions | Drugs such as NSAIDS (including salicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIb/IIIa antagonists (including abciximab, eptifibatide, and tirofiban), and others that interfere with platelet-aggregation reactions (the … |
| Ibuprofen | drug interactions | Drugs such as NSAIDS (including salicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIb/IIIa antagonists (including abciximab, eptifibatide, and tirofiban), and others that interfere with platelet-aggregation reactions (the … |
| Indomethacin | drug interactions | Drugs such as NSAIDS (including salicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIb/IIIa antagonists (including abciximab, eptifibatide, and tirofiban), and others that interfere with platelet-aggregation reactions (the … |
| Nicotine | drug interactions | Other Interactions Digitalis, tetracyclines, nicotine or antihistamines may partially counteract the anticoagulant action of heparin sodium. |
| Nitroglycerin | drug interactions | Intravenous nitroglycerin administered to heparinized patients may result in a decrease of the partial thromboplastin time with subsequent rebound effect upon discontinuation of nitroglycerin. |
| Rivaroxaban | drug interactions | Avoid use of heparin after use of andexanet alfa for the reversal of direct Factor Xa inhibitors (apixaban and rivaroxaban). |
| Salicylic acid | drug interactions | Drugs such as NSAIDS (including salicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIb/IIIa antagonists (including abciximab, eptifibatide, and tirofiban), and others that interfere with platelet-aggregation reactions (the … |
| Tirofiban | drug interactions | Drugs such as NSAIDS (including salicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIb/IIIa antagonists (including abciximab, eptifibatide, and tirofiban), and others that interfere with platelet-aggregation reactions (the … |
| Warfarin | drug interactions | Therefore, when heparin sodium is given with dicumarol or warfarin sodium, a period of at least 5 hours after the last intravenous dose or 24 hours after the last subcutaneous dose should elapse before blood is drawn, if a valid prothrombin time is to be obtained. |
Other labels that name heparin
- Alprostadil
- Alteplase
- Argatroban
- Aspirin and oxycodone
- Aspirin, butalbital, caffeine and codeine
- Bivalirudin
- Caplacizumab
- Cyclosporine
- Dabigatran
- Dalteparin
- Darbepoetin alfa
- Defibrotide
- Dextran 40
- Drospirenone
- Enoxaparin
- Epoetin
- Hydrochlorothiazide and spironolactone
- Ketorolac
- Lanadelumab
- Methoxy polyethylene glycol-epoetin beta
- Olmesartan
- Olsalazine
- Oritavancin
- Palifermin
- Perindopril
- Phytonadione
- Piperacillin and tazobactam
- Prasugrel
- Protamine
- Sertraline
- Sildenafil
- Sodium tetradecyl
- Sugammadex
- Telavancin
- Tenecteplase
- Tetradecyl hydrogen
- Ticagrelor
- Valsartan
Source: FDA drug label (Heparin Sodium), Fresenius Kabi USA, LLC, effective November 28, 2025 (SPL set d55b4a63-0c04-4874-b74f-9e9b9e8b008c), via openFDA; the full label on DailyMed
What do FAERS reports show for heparin?
The FDA Adverse Event Reporting System holds 13,673 reports that list heparin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,609 are coded as a death and 5,454 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does heparin compare with medicines for the same use?
2 side-by-side pages set heparin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other anti-coagulants
- the pharmacologic class, with prices and generics
- Heparin side effects
- the label's list beside FAERS reports
- Heparin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other