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Heparin Sodium 1000 [USP'U]/mL Injection, Solution — NDC 55154-9583-05 package photo

Heparin Sodium 1000 [USP'U]/mL Injection, Solution

by Cardinal Health 107, LLC · 5 VIAL in 1 BAG (55154-9583-5) / 10 mL in 1 VIAL
NDC 55154-9583-05
🏷️ FDA NDC (as labeled) 55154-9583-5 billing pads the package segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 3, 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

FDA NDC (as labeled) 55154-9583-5
Product NDC 55154-9583
11-digit billing NDC 55154958305
RxCUI 1361226
UNII ZZ45AB24CA
UPC 0055154958356
Application # NDA017029
SPL Set ID 239b4816-6a55-451b-bf40-e611be07d12f
Established class (EPC) Anti-coagulant; Unfractionated Heparin
Chemical class Heparin
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-11-04
Route INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance HEPARIN SODIUM
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 55154-9583-5 — 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 → 55154-9583-05. 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.

🏭 Manufacturer & labeler

LabelerCardinal Health 107, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA017029 (NDA)
Labeler code55154
First marketedNov 2019
Product typeHuman Prescription Drug
Portfolio472 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.

🩺 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
  • Heparin is a powerful blood thinner that stops dangerous clots from forming or getting bigger. Depending on your situation, it might be preventing a clot from traveling to your lun...
  • Why do I need heparin — what is it actually doing for me?
  • Heparin is always injected — your stomach can't absorb it, so pills aren't an option. In the hospital, it's often given as a continuous drip into a vein (IV infusion) or as an inte...
  • How is heparin given — do I have to get it through an IV the whole time?
📖 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.

🧪 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.

  • 1.5 mg / 1 mL UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 0.15 mg / 1 mL UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 9 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 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.

💲 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 · Q2 2026 $1.43 $71.65 / 50 ml
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Heparin Sodium 1000 [USP'U]/mL 00404-9979-01 Henry 1 vial — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 00409-2720-01 Hospira, 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 00641-0391-12 Hikma 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 00781-3538-25 Sandoz 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 00781-3540-25 Sandoz 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 00781-3543-25 Sandoz 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 25021-0400-01 Sagent 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mLthis 55154-9583-05 Cardinal 5 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 63323-0540-13 Fresenius 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 65219-0066-10 Fresenius 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 67457-0372-99 Mylan 25 vials — AP Discontinued —
Heparin Sodium 1000 [USP'U]/mL 67457-0384-99 Mylan 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 67457-0385-99 Mylan 25 vials — AP Discontinued —
Heparin Sodium 1000 [USP'U]/mL 68083-0427-25 Gland 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 68083-0428-25 Gland 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 71288-0402-02 Meitheal 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 71288-0449-02 Meitheal 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 71872-7351-01 Medical 1 vial — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 71872-7352-01 Medical 1 vial — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 71872-7364-01 Medical 1 vial — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 71872-7365-01 Medical 1 vial — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 72603-0179-25 NorthStar 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 72603-0250-25 Northstar 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 72603-0267-25 NorthStar 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 81565-0203-02 Phlow 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 81952-0112-06 Hepalink 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 72572-0250-25 Civica, 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 63323-0276-02 Fresenius 25 vials — AP Discontinued —
Heparin Sodium 1000 [USP'U]/mL 63739-0931-28 McKesson 25 vials — AP Discontinued —
Heparin Sodium 1000 [USP'U]/mL 00069-0043-01 Pfizer 25 vials — — FDA listed —
Heparin Sodium 1000 [USP'U]/mL 63739-0900-26 McKesson 25 vials — AP Discontinued —
Heparin Sodium 1000 [USP'U]/mL 63739-0920-25 McKesson 25 vials — AP Discontinued —
Heparin Sodium 1000 [USP'U]/mL 63739-0942-29 McKesson 25 vials — AP Discontinued —
Heparin Sodium 1000 [USP'U]/mL 81952-0115-07 Hepalink 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 72603-0234-25 NorthStar 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 00781-3555-25 Sandoz 25 vials — AP FDA listed —
Heparin Sodium 1000 [USP'U]/mL 25021-0401-02 Sagent 25 vials — AP FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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
Nov 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
55154-9583-05 You're viewing this 5 VIAL in 1 BAG (55154-9583-5) / 10 mL in 1 VIAL 2019-11-04 Active

🧭 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 — 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 FDA registers it as 55154-9583-5, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 55154-9583-05, written without dashes as 55154958305. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 55154-9583-05, the first segment (55154) is the labeler code FDA assigned to Cardinal Health 107, LLC; the middle segment (9583) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Cardinal Health 107, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cardinal Health 107, LLC 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 187 words ▾

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.

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

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION 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.

2.1Preparation 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 [ s ee 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 administration, the container should be inverted at least six times to ensure adequate mixing and prevent pooling of the heparin in the solution.

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 *Based on 68 kg patient METHOD OF ADMINISTRATION FREQUENCY RECOMMENDED DOSE Deep Subcutaneous (Intrafat) Injection Use a different site for each injection to prevent the development of hematoma Initial Dose 5,000 units by intravenous injection, followed by 10,000 to 20,00…

💊 Dosage Forms and Strengths ~1 min read ▾

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 • 5,000 USP units per 0.5 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 • 40,000 USP units per 4 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 Heparin Sodium Injection, USP (porcine), preservative free Heparin Sodium Injection, USP (porcine) contains benzyl alcohol Heparin Sodium Injection, USP (porcine) contains parabens 2 mL single-dose vial contains 2,000 USP units 10 mL multiple-dose vial contains 50,000 USP units 1 mL multiple-dose vial contains 1,000 USP units 0.5 mL single-dose vial contains 5,000 USP units 4 mL multiple-dose vial contains 40,000 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

⛔ Contraindications 176 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 ( 6.1 )]; • 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. • 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 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • 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 )

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 o 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/mm 3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate f…

🤒 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 )] 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 Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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: o Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred with heparin therapy, including fatal cases. o Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term heparin therapy. o 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.

🔄 Drug Interactions ~1 min read ▾

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

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 • 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 )

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 2-4% 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 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 )] . Benzyl Alcohol Toxicity Use preservative-free H…

🤰 Pregnancy ~2 min read ▾

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 2-4% 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.

🧒 Pediatric Use 210 words ▾

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 of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.

🧓 Geriatric Use 71 words ▾

8.5Geriatric Use There are limited adequate and well-controlled studies in patients 65 years and older, however, a higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age [see Warnings and Precautions ( 5.2 )] . Patients over 60 years of age may require lower doses of heparin. Lower doses of heparin may be indicated in these patients [see Clinical Pharmacology ( 12.3 )] .

🆘 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 )] .

🧬 Mechanism of Action 90 words ▾

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.

📦 How Supplied / Storage and Handling 126 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Heparin Sodium Injection, USP (porcine) contains parabens and is available as follows: Product Code Unit of Sale Strength Each 504015 Overbagged with 5 x 10 mL multiple-dose, flip-top vial in each bag, NDC 55154-9583-5 10,000 USP units per 10 mL (1,000 USP units per mL) 10 mL multiple-dose, flip-top vial WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. 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].

📦 Storage and Handling 14 words ▾

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). Each 0.5 mL of the 5,000 units per 0.5 mL preparation contains: 5,000 USP Heparin units (porcine); 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 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).

Each mL of the 10,000 units per mL preparation contains: 10,000 USP Heparin units (porcine); 5 mg sodium chloride; 10.42 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). hepar-struc-01.jpg

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Hemorrhage Inform patients that it may take them longer than usual to stop bleeding, that they may bruise and/or bleed more easily when they are treated with heparin, and that they should report any unusual bleeding or bruising to their physician. Hemorrhage can occur at virtually any site in patients receiving heparin. Fatal hemorrhages have occurred [see Warnings and Precautions ( 5.2 )] .

Prior to Surgery Advise patients to inform physicians and dentists that they are receiving heparin before any surgery is scheduled [see Warnings and Precautions ( 5.2 )] . Heparin-Induced Thrombocytopenia Inform patients of the risk of heparin-induced thrombocytopenia (HIT). HIT may progress to the development of venous and arterial thromboses, a condition known as heparin-induced thrombocytopenia and thrombosis (HITT).

HIT and HITT can occur up to several weeks after the discontinuation of heparin therapy [see Warnings and Precautions ( 5.3 )] . Hypersensitivity Inform patients that generalized hypersensitivity reactions have been reported. Necrosis of the skin has been reported at the site of subcutaneous injection of heparin [see Warnings and Precautions ( 5.8 ), Adverse Reactions ( 6.1 )] .

Other Medications Because of the risk of hemorrhage, advise patients to inform their physicians and dentists of all medications they are taking, including non-prescription medications, and before starting any new medication [see Drug Interactions ( 7.1 )] . Lake Zurich, IL 60047 www.fresenius-kabi.com/us Distributed By: Cardinal Health Dublin, OH 43017 L56459080124 451645B hepar-img-01.jpg

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