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Heparin Sodium 5000 [USP'U]/mL Injection, Solution — NDC 00781-3550-25 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 — NDC 0781-3550-25 (Billing 00781-3550-25)

by Sandoz Inc. · 25 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE

This is a package of Heparin Sodium 5000 [USP'U]/mL Injection, Solution from Sandoz Inc., marketed since Jun 2014 and currently FDA-listed. It is this product's only package size.

NDC 00781-3550-25
🏷️ FDA NDC (as labeled) 0781-3550-25 billing pads the labeler 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 Oct 1, 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

⚠️
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) 0781-3550-25
Product NDC 0781-3550
11-digit billing NDC 00781355025
NCPDP billing unit ML — per mL (volume)
RxCUI 1361226, 1361574, 1361615, 1362831, 1658647
UNII ZZ45AB24CA
UPC 0307813545101, 0307813439103, 0307813555254, 0307813541103 +10 more
Application # ANDA202733
SPL Set ID 1c634e53-44d6-cdcd-e063-6294a90a92e9
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 2014-06-12
Route INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance HEPARIN SODIUM
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 83100020202025
GCN Seq No 006549
GCN 25691
HICL code 002810
Ingredient (HICL) Heparin Sodium,Porcine
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M9
Therapeutic class — intermediate (HIC2) Drugs Given To Alter Blood Coagulation
HIC3 code M9K
Therapeutic class — specific (HIC3) Heparin And Related Preparations
AHFS code 20:12.04.16
AHFS class Heparins
FDB label name HEPARIN 50,000 UNIT/10 ML VIAL
FDB brand name Heparin Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006549
  • GCN: 25691
  • GPI-14 (Medi-Span): 83100020202025
  • HICL (First Databank): 002810
  • AHFS class code: 20:12.04.16
  • RxCUI (RxNorm): 1361226
Why two NDCs? The FDA registers this code as 0781-3550-25 — a 4-4-2 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 labeler segment → 00781-3550-25. 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

Label name HEPARIN 50,000 UNIT/10 ML VIAL Ingredient Heparin Sodium,Porcine
📗 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 $743.11 $185,778.73 / 250 ml
Medicare drug plans payPart D · Q2 2026 $1.43 $358.25 / 250 ml
Medicare Part B allowsASP · J1644 $0.199 / J1644 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)0781-3550-25
11-digit billing NDC00781-3550-25
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1644
DescriptorINJECTION, HEPARIN SODIUM, PER 1000 UNITS
Billing units / pkg5 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 1000 U, so one package = 5 billing units.
Medicare Part B spend (2026 (Q1))$41,880 · 6,338 claims · $6.61 per claim (all NDCs under J1644)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00781-3550-25 You're viewing this Main listing 25 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE 2024-09-16 — 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 00409-2723-01 Hospira, 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 00781-3545-25 Sandoz 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 63323-0262-06 Fresenius 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 71288-0450-02 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 72572-0255-25 Civica, 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]/mLthis 00781-3550-25 Sandoz 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 55154-9585-05 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 68083-0136-25 Gland 25 vials — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 72603-0214-25 NorthStar 25 vials — AP FDA listed —
Heparin Sodium 5000 [USP'U]/mL 81952-0114-09 Hepalink 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 51662-1460-01 HF 1 ml — — FDA listed —
Heparin Sodium 5000 [USP'U]/mL 63323-0047-10 Fresenius 25 vials — AP Discontinued —
Heparin Sodium 5000 [USP'U]/mL 00409-1402-12 Hospira, 50 cartridges — — Discontinued —
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 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 00641-6199-10 Hikma 10 syringes — 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

🏛️
2014
On the market since
Jun 2014
📍
2026
Currently FDA-listed
12 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.

  • 15 mg / 1 mL 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.
  • 6 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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.

5 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

LabelerSandoz Inc.
Application holderSHENZHEN TECHDOW PHARMACEUTICAL CO LTD
FDA applicationANDA202733 (ANDA)
Labeler code00781
First marketedJun 2014
Product typeHuman Prescription Drug
Portfolio50 products on file
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 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 173 words ▾

Heparin sodium injection is an anticoagulant indicated for ( 1 ) 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 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 Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures

1 INDICATIONS AND 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 abdominothoracic 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 ▾

Recommended Adult Dosages: Therapeutic Anticoagulant Effect with Full-Dose Heparin† ( 2.3 ) Deep Subcutaneous (Intrafat) Injection Use a different site for each injection Initial Dose 5,000 units by intravenous injection followed by 10,000 to 20,000 units of a concentrated solution, subcutaneously Every 8 hours or Every 12 hours 8,000 to 10,000 units of a concentrated solution 15,000 to 20,000 units of a concentrated solution Intermittent Intravenous Injection Initial Dose 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP Every 4 to 6 hours 5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP Intravenous Infusion Initial Dose 5,000 units by intravenous injection Continuous 20,000 to 40,000 units/24 hours in 1,000 mL of 0.9% Sodium Chloride Injection, USP (or in any compatible solution) for infusion † Based on 150 lb (68 kg) patient.

Adjust dose based on laboratory monitoring.

2 DOSAGE AND ADMINISTRATION

2.1Preparation for Administration Confirm the choice of the correct heparin sodium injection vial to ensure that the 1 mL vial is not confused with a “catheter lock flush” vial or other 1 mL vial of incorrect strength [see Warnings and Precautions ( 5.1 )] . Confirm the selection of the correct formulation and strength prior to administration of the drug. 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. When heparin is added to an infusion solution for continuous intravenous (IV) administration, invert the container at least six times to ensure adequate mixing and prevent pooling of the heparin in the solution.

Storage of prepared infusion solution should not exceed 4 hours at room temperature or 24 hours at 2°C to 8°C (36° to 46°F). 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. The intramuscular route of administration should be avoided because of the frequent occurrence of hematoma at the injection site [see Adverse Reactions ( 6.1 )] .

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. Periodically monitor platelet counts, hematocrit, and occult blood in stool 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: Table 1: Recommended Adult Full-Dose Heparin Regimens for Therapeutic Anticoagulant Effect Method of Administration Frequency Recommended Dose Deep Subcutaneous (Intrafat) Injection Use a different site for each injection to prevent the developmen… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 206 words ▾

Heparin Sodium Injection, USP (porcine), preservative free 2 mL single-dose vial contains 2,000 USP units Heparin sodium injection, USP contains benzyl alcohol: 10 mL multiple-dose vial contains 50,000 USP units Heparin sodium injection, USP contains parabens: 1 mL multiple-dose vial contains 1,000 USP units 10 mL multiple-dose vial contains 10,000 USP units 30 mL multiple-dose vial contains 30,000 USP units 1 mL multiple-dose vial contains 5,000 USP units 1 mL multiple-dose vial contains 10,000 USP units 5 mL multiple-dose vial contains 50,000 USP units 1 mL multiple-dose vial contains 20,000 USP units

3 DOSAGE FORMS AND STRENGTHS Heparin sodium injection, USP is available as: Heparin sodium injection, USP, preservative free , is available as follows: 2,000 USP units per 2 mL, single-dose vial Heparin sodium injection, USP contains benzyl alcohol and is available as follows: 50,000 USP units per 10 mL, multiple-dose vial Heparin sodium injection, USP contains parabens and is available as follows: 1,000 USP units per mL, multiple-dose vial 10,000 USP units per 10 mL, multiple-dose vial 30,000 USP units per 30 mL, multiple-dose vial 5,000 USP units per mL, multiple-dose vial 10,000 USP units per mL, multiple-dose vial 50,000 USP units per 5 mL, multiple-dose vial 20,000 USP units per mL, multiple-dose vial

⛔ Contraindications 169 words ▾

History of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITTS) ( 4 ) Known hypersensitivity to heparin or pork products ( 4 ) In whom suitable blood coagulation tests cannot be performed at appropriate intervals ( 4 ) An uncontrolled bleeding state, except when this is due to disseminated intravascular coagulation ( 4 )

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 ( 6.1 )] ; 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 ▾

Fatal Medication Errors: Confirm choice of correct strength prior to administration ( 5.1 ) Hemorrhage: Hemorrhage, including fatal events, has occurred in patients receiving heparin. Use caution in conditions with increased risk of hemorrhage ( 5.2 ) HIT and HITTS: Monitor for signs and symptoms and discontinue if indicative of HIT and HITTS ( 5.3 ) Benzyl Alcohol Toxicity: Use preservative-free formulation in neonates and infants Monitoring: Blood coagulation tests guide therapy for full-dose heparin. Periodically monitor platelet count, hematocrit, and occult blood in stool in all patients receiving heparin ( 5.5 , 5.6 ) Hyperkalemia: Measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients.

( 5.9 )

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 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 to confirm the correct vial 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 ( 6.1 )] . 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 dea… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITTS, injection site irritation, general hypersensitivity reactions, and elevations of aminotransferase levels. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 )] Hyperkalemia [see Warnings and Precautions ( 5.9 )]

6.1Postmarketing 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−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 including: 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. Others - 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.

Metabolism and Nutrition Disorders – Hyperkalemia.

🔄 Drug Interactions ~1 min read ▾

Drugs that interfere with coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding ( 7.2 )

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 ▾

Pregnancy: Preservative-free formulation recommended. ( 8.1 ) Lactation: Preservative-free formulation recommended. ( 8.2 ) Pediatric Use: Use preservative-free formulation in neonates and infants. ( 8.4 ) See 17 for PATIENT COUNSELING INFORMATION

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on heparin sodium 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 Use in Specific Populations ( 8.4 ) ].

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 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 breastfed 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 breastfed 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 )] . Be… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 140 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 ~1 min read ▾

16 HOW SUPPLIED Heparin sodium injection, USP (porcine), preservative free , is available as follows: NDC Number Concentration Vial Fill Volume Vial Type Pack Size 0781-3555-25 1,000 USP Heparin Units/mL 2 mL Single-Dose Vial Carton of 25 vials Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. This container closure is not made with natural rubber latex.

Discard unused portion. Heparin Sodium Injection, USP (porcine) contains benzyl alcohol and is available as follows: NDC Number Concentration Vial Fill Volume Vial Type Pack Size 0781-3550-25 5,000 USP Heparin Units/mL 10 mL Multiple-Dose Vial Carton of 25 vials Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate.

This container closure is not made with natural rubber latex. Heparin Sodium Injection, USP (porcine) contains parabens and is available as follows: NDC Number Concentration Vial Fill Volume Vial Type Pack Size 0781-3538-25 1,000 USP Heparin Units/mL 1 mL Multiple-Dose Vial Carton of 25 vials 0781-3540-25 1,000 USP Heparin Units/mL 10 mL Multiple-Dose Vial Carton of 25 vials 0781-3543-25 1,000 USP Heparin Units/mL 30 mL Multiple-Dose Vial Carton of 25 vials 0781-3545-25 5,000 USP Heparin Units/mL 1 mL Multiple-Dose Vial Carton of 25 vials 0781-3439-25 10,000 USP Heparin Units/mL 1 mL Multiple-Dose Vial Carton of 25 vials 0781-3533-25 10,000 USP Heparin Units/mL 5 mL Multiple-Dose Vial Carton of 25 vials 0781-3541-25 20,000 USP Heparin Units/mL 1 mL Multiple-Dose Vial Carton of 25 vials Use only if solution is clear and seal intact.

Do not use if solution is discolored or contains a precipitate. This container closure is not made with natural rubber latex. STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description ~2 min read ▾

11 DESCRIPTION Heparin is a heterogeneous 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. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection.

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. Structure of Heparin Sodium (representative subunits): Heparin sodium injection, USP (porcine), preservative free, is available as follows: Each mL of the 1,000 units per mL preparation contains: 1,000 USP Heparin units (porcine); 9 mg sodium chloride; Water for Injection q.s. made isotonic with sodium chloride.

Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Heparin sodium injection, USP (porcine), preserved with benzyl alcohol, is available as follows: Each mL of the 5,000 units per mL preparation contains: 5,000 USP Heparin units (porcine); 6 mg sodium chloride; 15 mg benzyl alcohol (as a preservative); Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5).

Heparin Sodium Injection, USP (porcine), preserved with parabens, is available as follows: Each mL of the 1,000 units per mL preparation contains: 1,000 USP Heparin units (porcine); 9 mg sodium chloride; 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. made isotonic with sodium chloride. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each mL of the 5,000 units per mL preparation contains: 5,000 USP Heparin units (porcine); 5 mg sodium chloride; 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s.

Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each mL of the 10,000 units per mL preparation contains: 10,000 USP Heparin units (porcine); 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5).

Each mL of the 20,000 units per mL preparation contains: 20,000 USP Heparin units (porcine); 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Heparin Chemical 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.

📄 Recent Major Changes 8 words ▾

Warnings and Precautions, Hyperkalemia ( 5.9 ) 7/2024

📄 Package Label / Principal Display Panel ~3 min read ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5,000 USP Units/mL - 1 mL Container Label NDC 0781-3545-10 Rx only HEPARIN SODIUM INJECTION, USP 5,000 USP Units/mL For IV or SC use Multiple-Dose Vial 1 mL NOT FOR LOCK FLUSH heparin-fig1

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5,000 USP Units/mL - 1 mL Container-Carton [25 Multiple Dose Vials] NDC 0781-3545-25 Rx only HEPARIN SODIUM INJECTION, USP 5,000 USP Units/mL For Intravenous or Subcutaneous use 25 Multiple-Dose Vials Derived from Porcine Intestinal Mucosa NOT FOR LOCK FLUSH 1 mL heparin-fig2

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2,000 USP Units/2mL - 2 mL Container Label NDC 0781-3555-10 Rx only HEPARIN SODIUM INJECTION, USP 2,000 USP Units/2mL (1,000USP Units/mL) For IV or SC use Preservative Free Discard unused portion Single-Dose Vial 2mL NOT FOR LOCK FLUSH heparin-fig3

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2,000 USP Units/2mL - 2 mL Container-Carton [25 Single Dose Vials] NDC 0781-3555-25 Rx only HEPARIN SODIUM INJECTION, USP 2,000 USP Units/2mL (1,000 USP Units/mL) For Intravenous or Subcutaneous use Preservative Free NOT FOR LOCK FLUSH 25 Single-Dose Vials Derived from Porcine Intestinal Mucosa 2 mL heparin-fig4

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1, 000 USP Units/mL - 1 mL Container Label NDC 0781-3538-10 Rx only HEPARIN SODIUM INJECTION, USP 1,000 USP Units/mL For IV or SC use Multiple-Dose Vial 1mL NOT FOR LOCK FLUSH heparin-fig5

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1,000 USP Units/mL - 1 mL Container-Carton [25 Multiple Dose Vials] NDC 0781-3538-25 Rx only HEPARIN SODIUM INJECTION, USP 1,000 USP Units/mL For Intravenous or Subcutaneous use 25 Multiple-Dose Vials Derived from Porcine Intestinal Mucosa NOT FOR LOCK FLUSH 1 mL heparin-fig6

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10,000 USP Units/10mL - 10 mL Container Label NDC 0781-3540-10 Rx only HEPARIN SODIUM INJECTION, USP 10,000 USP Units/10mL (1,000 USP Units/mL) For IV or SC use Multiple-Dose Vial 10mL NOT FOR LOCK FLUSH heparin-fig7

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10,000 USP Units/10mL - 10 mL Container-Carton [25 Multiple Dose Vials] NDC 0781-3540-25 Rx only HEPARIN SODIUM INJECTION, USP 10,000 USP Units/10mL (1,000 USP Units/mL) For Intravenous or Subcutaneous use 25 Multiple Dose Vials Derived from Porcine Intestinal Mucosa NOT FOR LOCK FLUSH 10 mL heparin-fig8

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10, 000 USP Units/mL - 1 mL Container Label NDC 0781-3439-10 Rx only HEPARIN SODIUM INJECTION, USP 10,000 USP Units/mL For IV or SC use Multiple-Dose Vial 1mL NOT FOR LOCK FLUSH heparin-fig9

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10,000 USP Units/mL - 1 mL Container-Carton [25 Multiple Dose Vials] NDC 0781-3439-25 Rx only HEPARIN SODIUM INJECTION, USP 10,000 USP Units/mL For Intravenous or Subcutaneous use 25 Multiple-Dose Vials Derived from Porcine Intestinal Mucosa NOT FOR LOCK FLUSH 1 mL heparin-fig10

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20, 000 USP Units/mL - 1 mL Container Label NDC 0781-3541-10 Rx only HEPARIN SODIUM INJECTION, USP 20,000 USP Units/mL For IV or SC use Multiple-Dose Vial 1mL NOT FOR LOCK FLUSH heparin-fig11

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20,000 USP Units/mL - 1 mL Container-Carton [25 Multiple Dose Vials] NDC 0781-3541-25 Rx only HEPARIN SODIUM INJECTION, USP 20,000 USP Units/mL For Intravenous or Subcutaneous use 25 Multiple-Dose Vials Derived from Porcine Intestinal Mucosa NOT FOR LOCK FLUSH 1 mL heparin-fig12

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 30, 000 USP Units/30mL - 30 mL Container Label NDC 0781-3543-10 Rx only HEPARIN SODIUM INJECTION, USP 30,000 USP Units/30mL (1,000 USP Units/mL) For IV or SC use Multiple-Dose Vial 30mL NOT FOR LOCK FLUSH heparin-fig13

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 30,000 USP Units/30mL - 30 mL Container-Carton [25 Multiple Dose Vials] NDC 0781-3543-25 Rx only HEPARIN SODIUM INJECTION, USP 30,000 USP Units/30mL (1,000USP Units/mL) For Intravenous or Subcutaneous use 25 Multiple-Dose Vials Derived from Porcin… [Excerpted — this section continues on DailyMed.]

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
16
Units reimbursed last 4 qtrs
51
Gross reimbursed last 4 qtrs
$37.9K
Avg / prescription
$2,368.68
Avg / unit
$740.21
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 16 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 51 units · 0.3 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.30.3
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 0.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 Sandoz Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sandoz Inc. 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1644 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 00781-3545-25 · Sandoz 00781-3555-25 · Sandoz →
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.