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HEPARIN SODIUM 5000 [USP'U]/mL Injection, Solution, 1 mL — NDC 51662-1460-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

HEPARIN SODIUM 5000 [USP'U]/mL Injection, Solution, 1 mL — NDC 51662-1460-1 (Billing 51662-1460-01)

by HF Acquisition Co LLC, DBA HealthFirst · 1 mL in 1 CARTRIDGE

This is a package of 1 mL of HEPARIN SODIUM 5000 [USP'U]/mL Injection, Solution from HF Acquisition Co LLC, DBA HealthFirst, marketed since Dec 2019 and currently FDA-listed. It is this product's only package size.

NDC 51662-1460-01
🏷️ FDA NDC (as labeled) 51662-1460-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 51662-1460-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
51662 labeler · 1460 product · 1 package
Package marketed since
Dec 22, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5166214601 9
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Heparin Sodium (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Aug 1, 2024 — Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. (Baxter Healthcare Corporation) · FDA recall D-0649-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51662-1460-1
Product NDC 51662-1460
11-digit billing NDC 51662146001
RxCUI 1659260
UNII ZZ45AB24CA
Application # ANDA088100
SPL Set ID 9a5549ae-527a-1b83-e053-2a95a90a133d
Established class (EPC) Anti-coagulant; Unfractionated Heparin
Chemical class Heparin
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-12-22
Route INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance HEPARIN SODIUM
Quick answers
  • RxCUI (RxNorm): 1659260
Why two NDCs? The FDA registers this code as 51662-1460-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 51662-1460-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Unfractionated Heparin class.

Pharmacologic class Unfractionated Heparin, Anti-coagulant
Drug family (ATC) Heparin group, Heparins or heparinoids for topical use, Other ophthalmologicals
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Heparin is used to: prevent blood clots from forming in people who have certain medical conditions or who are undergoing certain medical procedures. stop the growth of clots that have already formed in the blood vessels. prevent blood clots from forming in catheters (small plastic tubes through which medication can be administered or blood drawn). treat certain types of blood disorders. Heparin is in a class of medications called anticoagulants ('blood thinners'). It works by decreasing the clotting ability of the blood.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It prevents and treats dangerous blood clots, like those in the veins and lungs or linked to atrial fibrillation. It is also used to keep blood from clotting during heart and arter...
  • Heparin is given by injection, either into a vein or deep under the skin depending on the product. It is never taken by mouth or injected into the muscle. Your care team adjusts it...
  • Minor bruising or bleeding, and redness or soreness where it is injected, are the most common. Some people get chills, fever, hives or itching. Bleeding is the main concern.
  • Call for help if you have nosebleeds that won’t stop, blood in your urine, black tarry stools, or a sudden drop in strength or blood pressure. Also report new clots, chest pain, st...
📖 Read our full Heparin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Heparin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Heparin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51662-1460-01 You're viewing this Main listing 1 mL in 1 CARTRIDGE 2019-12-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Heparin Sodium 5000 [USP'U]/mL 63739-0953-25 McKesson 25 vials $1.166 AP Discontinued —
Heparin Sodium 5000 [USP'U]/mL 63323-0262-06 Fresenius 25 vials $1.180 AP Availability likely —
Heparin Sodium 5000 [USP'U]/mL 25021-0402-01 Sagent 25 vials $1.180 AP Availability likely —
Heparin Sodium 5000 [USP'U]/mL 71288-0403-02 Meitheal 25 vials $1.180 AP Availability likely —
Heparin Sodium 5000 [USP'U]/mL 72603-0456-25 Northstar 25 vials $1.180 AP Availability likely —
Heparin Sodium 5000 [USP'U]/mL 81952-0111-06 Hepalink 25 vials $1.180 AP Availability likely —
Heparin Sodium 5000 [USP'U]/mL 00641-0400-12 Hikma 25 vials $1.180 AP Availability likely —
Heparin Sodium 5000 [USP'U]/mL 71288-0450-02 Meitheal 25 vials $1.180 AP Availability likely —
Heparin Sodium 5000 [USP'U]/mL 00409-2723-01 Hospira, 25 vials $1.180 AP Availability likely —
Heparin Sodium 5000 [USP'U]/mL 72572-0255-25 Civica, 25 vials $1.180 AP Availability likely —
Heparin Sodium 5000 [USP'U]/mL 00781-3545-25 Sandoz 25 vials $1.180 AP Availability likely —
Heparin Sodium 5000 [USP'U]/mL 72603-0412-25 NorthStar 25 vials $1.180 AP Availability likely —
Heparin Sodium 5000 [USP'U]/mL 67457-0374-99 Mylan 25 vials $1.202 AP Discontinued —
Heparin Sodium 5000 [USP'U]/mL 71288-0406-82 Meitheal 1 syringe $3.191 AP Availability likely —
Heparin Sodium 5000 [USP'U]/mL 00409-1402-12 Hospira, 50 cartridges — — Discontinued —
Heparin Sodium 5000 [USP'U]/mLthis 51662-1460-01 HF 1 ml — — FDA listed —
Heparin Sodium 5000 [USP'U]/mL 81952-0114-09 Hepalink 25 vials — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 55154-2827-05 Cardinal 5 vials — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 63323-0047-10 Fresenius 25 vials — AP Discontinued —
Heparin Sodium 5000 [USP'U]/mL 00781-3550-25 Sandoz 25 vials — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 87188-0102-90 Plano 25 vials — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 70518-4547-00 REMEDYREPACK 25 vials — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 55154-6985-05 Cardinal 5 vials — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 55154-5130-05 Cardinal 5 vials — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 67457-0383-99 Mylan 25 vials — AP Discontinued —
Heparin Sodium 5000 [USP'U]/mL 00404-9872-01 Henry 1 vial — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 76045-0108-10 Fresenius 1 syringe — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 63739-0901-28 McKesson 25 vials — AP Discontinued —
Heparin Sodium 5000 [USP'U]/mL 68083-0136-25 Gland 25 vials — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 00641-6199-10 Hikma 10 syringes — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 55154-9585-05 Cardinal 5 vials — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 72603-0214-25 NorthStar 25 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Dec 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderHOSPIRA INC
FDA applicationANDA088100 (ANDA)
Labeler code51662
First marketedDec 2019
Product typeHuman Prescription Drug
Portfolio333 products on file

More NDCs from HF Acquisition Co LLC, DBA HealthFirst labeler code 51662

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 85 words ▾

1 INDICATIONS & USAGE 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 abdomino-thoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; 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; Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE & ADMINISTRATION

2.1Preparation for Administration Confirm the choice of the correct Heparin Sodium Injection vial or cartridge prior to administration of the drug to a patient [see Warnings and Precautions (5.1)]. Heparin Sodium Injection, products must not be confused with "catheter lock flush" products. To lessen this risk for a cartridge, a red cautionary statement has been added to the cartridge and box/bin.

Read the cautionary statement and confirm that you have selected the correct medication and strength. When heparin is added to an infusion solution for continuous intravenous administration, invert the container repeatedly to ensure adequate mixing and prevent pooling of the heparin in the solution. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Use only if solution is clear and the seal is intact. Do not use if solution is discolored or contains a precipitate. Administer Heparin Sodium Injection by intermittent intravenous injection, intravenous infusion, or deep subcutaneous (intrafat, i.e., above the iliac crest or abdominal fat layer) injection.

Do not administer Heparin Sodium Injection by intramuscular injection because of the risk of hematoma at the injection site [see Adverse Reactions (6)].

2.2Laboratory Monitoring for Efficacy and Safety Adjust the dosage of Heparin Sodium Injection according to the patient's coagulation test results. Dosage is considered adequate when the activated partial thromboplastin time (aPTT) is 1.5 to 2 times normal or when the whole blood clotting time is elevated approximately 2.5 to 3 times the control value. When initiating treatment with Heparin Sodium Injection by continuous intravenous infusion, determine the coagulation status (aPTT, INR, platelet count) at baseline and continue to follow aPTT approximately every 4 hours and then at appropriate intervals thereafter.

When the drug is administered intermittently by intravenous injection, perform coagulation tests before each injection during the initiation of treatment and at appropriate intervals thereafter. After deep subcutaneous (intrafat) injections, tests for adequacy of dosage are best performed on samples drawn 4 to 6 hours after the injection. Periodic platelet counts, and hematocrits are recommended during the entire course of heparin therapy, regardless of the route of administration.

2.3Therapeutic Anticoagulant Effect With Full-Dose Heparin The dosing recommendations in Table 1 are based on clinical experience. Although dosages must be adjusted for the individual patient according to the results of suitable laboratory tests, the following dosage schedules may be used as guidelines:

2.4Pediatric Use Use preservative-free Heparin Sodium Injection in neonates and infants [see Warnings and Precautions (5.4)]. There are no adequate and well controlled studies on heparin use in pediatric patients. Pediatric dosing recommendations are based on clinical experience. In general, the following dosage schedule may be used as a guideline in pediatric patients:

2.5Cardiovascular Surgery Patients undergoing total body perfusion for open-heart surgery should receive an initial dose of not less than 150 units of heparin sodium per kilogram of body weight. Frequently, a dose of 300 units per kilogram is used for procedures estimated to last less than 60 minutes, or 400 units per kilogram for those estimated to last longer than 60 minutes.

2.6Low-Dose Prophylaxis of Postoperative Thromboembolism The most widely used dosage has been 5,000 units 2 hours before surgery and 5,000 units every 8 to 12 hours thereafter for 7 days or until the patient is fully ambulatory, whichever is longer. Administer the heparin by deep subcutaneous injection (intrafat, i.e., above the iliac crest or abdominal fat layer, arm, or thigh) with a fine (25 to 26-gauge) needle to minimize tissue trauma.

2.7Blood Transfusion Add 450 to 600 USP un… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 19 words ▾

3 DOSAGE FORMS & STRENGTHS Heparin Sodium: 5,000 USP Units/0.5 mL, Preservative free Heparin Sodium: 5,000 USP Units/1 mL

⛔ Contraindications 106 words ▾

4 CONTRAINDICATIONS The use of Heparin Sodium Injection is contraindicated in patients with the following conditions: History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see Warnings and Precautions (5.3)] Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions (6.2)] In whom suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low dose heparin) An uncontrolled active bleeding state [see Warnings and Precautions (5.4)], except when this is due to disseminated intravascular coagulation

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS

5.1Fatal Medication Errors Do not use Heparin Sodium Injection as a "catheter lock flush" product. Heparin Sodium Injection is supplied in vials and sterile cartridges containing various strengths of heparin, including vials that contain a highly concentrated solution of 10,000 units in 1 mL. Fatal hemorrhages have occurred in pediatric patients due to medication errors in which 1 mL Heparin Sodium Injection vials were confused with 1 mL "catheter lock flush" vials.

Carefully examine all Heparin Sodium Injection vials and cartridges to confirm the correct product choice prior to administration of the drug.

5.2Hemorrhage Avoid using heparin in the presence of major bleeding, except when the benefits of heparin therapy outweigh the potential risks. Hemorrhage can occur at virtually any site in patients receiving heparin. Fatal hemorrhages have occurred.

Adrenal hemorrhage (with resultant acute adrenal insufficiency), ovarian hemorrhage, and retroperitoneal hemorrhage have occurred during anticoagulant therapy with heparin [see Adverse Reactions (6.2)]. A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age [see Clinical Pharmacology (12.3)]. An unexplained fall in hematocrit, fall in blood pressure or any other unexplained symptom should lead to serious consideration of a hemorrhagic event.

Use Heparin Sodium with caution in disease states in which there is increased risk of hemorrhage, including: Cardiovascular — Subacute bacterial endocarditis, severe hypertension. Surgical — During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord, or eye. Hematologic — Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia, and some vascular purpuras.

Patients with hereditary antithrombin III deficiency receiving concurrent antithrombin III therapy — The anticoagulant effect of heparin is enhanced by concurrent treatment with antithrombin III (human) in patients with hereditary antithrombin III deficiency. To reduce the risk of bleeding, reduce the heparin dose during concomitant treatment with antithrombin III (human). Gastrointestinal — Ulcerative lesions and continuous tube drainage of the stomach or small intestine.

Other — Menstruation, liver disease with impaired hemostasis.

5.3Heparin-induced Thrombocytopenia and Heparin-Induced Thrombocytopenia and Thrombosis Heparin-Induced Thrombocytopenia (HIT) is a serious antibody-mediated reaction. HIT occurs in patients treated with heparin and is due to the development of antibodies to a platelet Factor 4-heparin complex that induce in vivo platelet aggregation. HIT may progress to the development of venous and arterial thromboses, a condition referred to as heparin-induced thrombocytopenia with thrombosis (HITT).

Thrombotic events may also be the initial presentation for HITT. These serious thromboembolic events include deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis, limb ischemia, stroke, myocardial infarction, mesenteric thrombosis, renal arterial thrombosis, skin necrosis, gangrene of the extremities that may lead to amputation, and possibly death. If the platelet count falls below 100,000/mm3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for HIT and HITT, and, if necessary, administer an alternative anticoagulant.

HIT or HITT can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of Heparin Sodium should be evaluated for HIT or HITT.

5.4Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including Heparin Sodium Injection multiple-dose vials. The "gasping syndrome" is characteriz… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions ( 5.2)] Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia and Thrombosis [see Warnings and Precautions ( 5.3)] Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative [see Warnings and Precautions (5.4)] Thrombocytopenia [see Warnings and Precautions (5.5)] Heparin Resistance [see Warnings and Precautions (5.7)] Hypersensitivity [see Warnings and Precautions (5.8)]

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of Heparin Sodium Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hemorrhage is the chief complication that may result from heparin therapy [see Warnings and precautions (5.2)].

Gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Bleeding can occur at any site but certain specific hemorrhagic complications may be difficult to detect: Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred with heparin therapy, including fatal cases. Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term heparin therapy Retroperitoneal hemorrhage.

HIT and HITT, including delayed onset cases [see Warnings and Precautions (5.3)]. Local Irritation- Local irritation, erythema, mild pain, hematoma or ulceration may follow deep subcutaneous (intrafat) injection of Heparin Sodium. Because these complications are much more common after intramuscular use, the intramuscular route is not recommended.

Histamine-like reactions- Such reactions have been observed at the site of injections. Necrosis of the skin has been reported at the site of subcutaneous injection of heparin, occasionally requiring skin grafting [see Warnings and Precautions (5.3)]. Hypersensitivity- Generalized hypersensitivity reactions have been reported, with chills, fever and urticaria as the most usual manifestations, and asthma, rhinitis, lacrimation, headache, nausea and vomiting, and anaphylactoid reactions, including shock, occurring less frequently.

Itching and burning, especially on the plantar side of the feet, may occur [see Warnings and Precautions (5.8)]. Elevations of aminotransferases- Significant elevations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels have occurred in patients who have received heparin [see Drug Interactions (7.4)]. Miscellaneous- Osteoporosis following long-term administration of high doses of heparin, cutaneous necrosis after systemic administration, suppression of aldosterone synthesis, delayed transient alopecia, priapism, and rebound hyperlipemia on discontinuation of Heparin Sodium have also been reported.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS

7.1Oral Anticoagulants Heparin Sodium may prolong the one-stage prothrombin time. 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.

7.2Platelet Inhibitors 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 main hemostatic defense of heparinized patients) may induce bleeding and should be used with caution in patients receiving Heparin Sodium. To reduce the risk of bleeding, a reduction in the dose of antiplatelet agent or heparin is recommended.

7.3Other Interactions Digitalis, tetracyclines, nicotine or antihistamines may partially counteract the anticoagulant action of Heparin Sodium. Intravenous nitroglycerin administered to heparinized patients may result in a decrease of the partial thromboplastin time with subsequent rebound effect upon discontinuation of nitroglycerin. Careful monitoring of partial thromboplastin time and adjustment of heparin dosage are recommended during coadministration of heparin and intravenous nitroglycerin.

Antithrombin III (human) – The anticoagulant effect of heparin is enhanced by concurrent treatment with antithrombin III (human) in patients with hereditary antithrombin III deficiency. To reduce the risk of bleeding, a reduced dosage of heparin is recommended during treatment with antithrombin III (human).

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on Heparin Sodium Injection use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. No teratogenicity, but early embryo-fetal death was observed in animal reproduction studies with administration of Heparin Sodium to pregnant rats and rabbits during organogenesis at doses approximately 10 times the maximum recommended human dose (MRHD) of 45,000 units/day [see Data].

Consider the benefits and risks of Heparin Sodium Injection for the mother and possible risks to the fetus when prescribing Heparin Sodium Injection to a pregnant woman. If available, preservative-free Heparin Sodium Injection is recommended when heparin therapy is needed during pregnancy. There are no known adverse outcomes associated with fetal exposure to the preservative benzyl alcohol through maternal drug administration; however, the preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants [see Warnings and Precautions (5.4)].

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Human Data The maternal and fetal outcomes associated with uses of heparin via various dosing methods and administration routes during pregnancy have been investigated in numerous studies.

These studies generally reported normal deliveries with no maternal or fetal bleeding and no other complications. Animal Data In a published study conducted in rats and rabbits, pregnant animals received heparin intravenously during organogenesis at a dose of 10,000 units/kg/day, approximately 10 times the maximum human daily dose based on body weight. The number of early resorptions increased in both species.

There was no evidence of teratogenic effects.

8.2Lactation Risk Summary If available, preservative-free Heparin Sodium Injection is recommended when heparin therapy is needed during lactation. Benzyl alcohol present in maternal serum is likely to cross into human milk and may be orally absorbed by a nursing infant. There is no information regarding the presence of Heparin Sodium Injection in human milk, the effects on the breastfed infant, or the effects on milk production.

Due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a nursing infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Heparin Sodium Injection and any potential adverse effects on the breastfed infant from Heparin Sodium Injection or from the underlying maternal condition [see Use in Specific Populations (8.4)].

8.4Pediatric Use There are no adequate and well controlled studies on heparin use in pediatric patients. Pediatric dosing recommendations are based on clinical experience [see Dosage and Administration (2.4)]. Carefully examine all Heparin Sodium Injection vials to confirm choice of the correct strength prior to administration of the drug.

Pediatric patients, including neonates, have died as a result of medication errors in which Heparin Sodium Injection vials have been confused with "catheter lock flush" vials [see Warnings and Precautions (5.1)]. Benzyl Alcohol Toxicity Use preservative-free Heparin Sodium Injection in neonates and infants. Serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative.

In these cases, benzyl alcohol dosages o… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 139 words ▾

10 OVERDOSAGE Bleeding is the chief sign of heparin overdosage. Neutralization of Heparin Effect When clinical circumstances (bleeding) require reversal of the heparin effect, protamine sulfate (1% solution) by slow infusion will neutralize heparin sodium. No more than 50 mg should be administered, very slowly, in any 10-minute period.

Each mg of protamine sulfate neutralizes approximately 100 USP Heparin Units. The amount of protamine required decreases over time as heparin is metabolized. Although the metabolism of heparin is complex, it may, for the purpose of choosing a protamine dose, be assumed to have a half-life of about 1/2 hour after intravenous injection.

Because fatal reactions often resembling anaphylaxis have been reported with protamine, it should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available. For additional information consult the labeling of Protamine Sulfate Injection.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Heparin interacts with the naturally occurring plasma protein, Antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin III, thereby inhibiting the activated coagulation factors involved in the clotting sequence, particularly Xa and IIa. Small amounts of heparin inhibit Factor Xa, and larger amounts inhibit thrombin (Factor IIa). Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor.

Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots.

12.2Pharmacodynamics Various times (activated clotting time, activated partial thromboplastin time, prothrombin time, whole blood clotting time) are prolonged by full therapeutic doses of heparin; in most cases, they are not measurably affected by low doses of heparin. The bleeding time is usually unaffected by heparin.

12.3Pharmacokinetics Absorption Heparin is not absorbed through the gastrointestinal tract and therefore administered via parenteral route. Peak plasma concentration and the onset of action are achieved immediately after intravenous administration. Distribution Heparin is highly bound to antithrombin, fibrinogens, globulins, serum proteases and lipoproteins. The volume of distribution is

0.07L/kg. Elimination Metabolism Heparin does not undergo enzymatic degradation. Excretion Heparin is mainly cleared from the circulation by liver and reticuloendothelial cells mediated uptake into extravascular space.

Heparin undergoes biphasic clearance, a) rapid saturable clearance (zero order process due to binding to proteins, endothelial cells and macrophage) and b) slower first order elimination. The plasma half-life is dose-dependent and it ranges from 0.5 to 2 h. Specific Populations Geriatric patients Patients over 60 years of age, following similar doses of heparin, may have higher plasma levels of heparin and longer activated partial thromboplastin times (APTTs) compared with patients under 60 years of age [see Use in Specific Populations (8.5)].

📦 How Supplied / Storage and Handling 80 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING HEPARIN SODIUM INJ, USP is supplied in the following dosage forms. NDC 51662-1460-1 HEPARIN SODIUM INJ, USP 5,000 USP UNITS/mL 1mL CARPUJECT HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Heparin Sodium is supplied in the following strengths and package configurations: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Do not freeze. Discard unused portion after initial use.

HOW SUPPLIED

📋 Description ~1 min read ▾

11 DESCRIPTION Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose, and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)> (1)> (4)> (3)> (5), and are joined by glycosidic linkages, forming polymers of varying sizes.

Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Structural formula of Heparin Sodium (representative subunits): Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity.

It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Carpuject™ sterile cartridge unit contain a sterile solution of Heparin Sodium Injection, USP.

Each mL contains 5,000 USP Units of heparin sodium and benzyl alcohol 1% as a preservative, in Water for Injection. The pH is adjusted between 5.0 to 7.5 with hydrochloric acid or sodium hydroxide. Each mL of Preservative-Free Heparin Sodium Injection contains 10,000 USP Units in Water for Injection.

The pH is adjusted between 5.0 to 7.5 with hydrochloric acid or sodium hydroxide as required. STRUCTURE

🧪 Nonclinical Toxicology 38 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies in animals have been performed to evaluate carcinogenic potential of heparin. Also, no reproduction studies in animals have been performed concerning mutagenesis or impairment of fertility.

📄 Patient Package Insert 37 words ▾

SPL UNCLASSIFIED Instructions for Use of the Syringe Systems Instructions for using the Carpuject™ Syringe are available with the reusable Carpuject™ Holder, List 2049-02. Carpuject™ Single-dose cartridges are to be used ONLY with Carpuject™ Holders, List 2049-02.

📄 Package Label / Principal Display Panel 54 words ▾

PACKAGE LABEL DISPLAY - SYRINGE CARTRIDGE LABEL OPT 1 SYRINGE CARTRIDGE LABEL OPT 1

PACKAGE LABEL DISPLAY - SYRINGE CARTRIDGE LABEL OPT 2 SYRINGE CARTRIDGE LABEL OPT 2

PACKAGE LABEL DISPLAY - SYRINGE CARTRIDGE LABEL OPT 3 PACSYRINGE CARTRIDGE LABEL OPT 3

PACKAGE LABEL DISPLAY - SERIALIZED SYRINGE CARTRIDGE LABELING SERIALIZED SYRINGE CARTRIDGE LABELING

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Heparin Sodium — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Heparin Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$515.1K
Claims incl. refills
9.6K
Beneficiaries
3.8K
Spend / beneficiary
$134.03
Spend / claim
$53.41
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by HF Acquisition Co LLC, DBA HealthFirst. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HF Acquisition Co LLC, DBA HealthFirst is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 51662-1459-01 · HF 51662-1461-01 · HF →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.