HomeNDC LookupIngredientsHeparin Sodium › 63323-0276-02
Heparin Sodium 1000 [USP'U]/mL Injection, Solution — NDC 63323-0276-02 package photo

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

by Fresenius Kabi USA, LLC · 25 VIAL in 1 TRAY (63323-276-02) / 2 mL in 1 VIAL (63323-276-01)
NDC 63323-0276-02
🏷️ FDA NDC (as labeled) 63323-276-02 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 63323-276-02
Product NDC 63323-276
11-digit billing NDC 63323027602
NCPDP billing unit ML — per mL (volume)
UNII ZZ45AB24CA
UPC 0363323276010, 0363323047016, 0363323543020
Application # NDA017029
SPL Set ID d55b4a63-0c04-4874-b74f-9e9b9e8b008c
Established class (EPC) Anti-coagulant; Unfractionated Heparin
Chemical class Heparin
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 1972-02-22
Route INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance HEPARIN SODIUM
GPI-14 83100020202015
GPI class Heparin Sodium (Porcine)
GCN Seq No 060309
GCN 26429
HICL code 033314
Ingredient (HICL) Heparin Sodium,Porcine/Pf
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 2,000 UNIT/2 ML VIAL
FDB brand name Heparin Sodium
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 63323-276-02 — a 5-3-2 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 product segment → 63323-0276-02. 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

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA017029 (NDA)
Labeler code63323
First marketedFeb 1972
Product typeHuman Prescription Drug
Portfolio554 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

Label name HEPARIN 2,000 UNIT/2 ML VIAL Ingredient Heparin Sodium,Porcine/Pf
📗 Our plain-language guide HelloPharmacist
  • Heparin works almost instantly when given into a vein, which makes it ideal for serious or urgent clotting situations — like a blood clot in the lungs, during surgery, or on dialys...
  • Why do I need heparin? Can't I just take a blood thinner pill?
  • Bleeding is the main concern with heparin. Watch for things like nosebleeds that won't stop, blood in your urine, black or tarry stools, unusual bruising, or any severe pain that c...
  • What side effect should I be most worried about?
📖 Read our full Heparin Injection guide →
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.

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.

  • 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.
  • 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 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.

3 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 DailyMedingredient 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 · quarterly No Part D plan price is available for this NDC in our data.
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)63323-276-02
11-digit billing NDC63323-0276-02
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1644
DescriptorINJECTION, HEPARIN SODIUM, PER 1000 UNITS
Billing units / pkg1 units
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Heparin Sodium 1000 [USP'U]/mL 00069-0043-01 Pfizer 25 vials 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
Heparin Sodium 2000 [USP'U]/2mL 71288-0400-03 Meitheal 25 vials AP FDA listed
Heparin Sodium 2000 [USP'U]/2mL 71839-0117-25 BE 25 vials AP FDA listed
Heparin Sodium 2000 [USP'U]/2mL 72603-0336-25 NorthStar 25 vials AP FDA listed
Heparin Sodium 1000 [USP'U]/mL 81952-0115-07 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 72603-0250-25 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 00641-0391-12 Hikma 25 vials AP FDA listed
Heparin Sodium 1000 [USP'U]/mLthis 63323-0276-02 Fresenius 25 vials AP Discontinued
Heparin Sodium 1000 [USP'U]/mL 63323-0540-13 Fresenius 25 vials AP FDA listed
Heparin Sodium 1000 [USP'U]/mL 63739-0931-28 McKesson 25 vials AP Discontinued
Heparin Sodium 1000 [USP'U]/mL 71288-0449-02 Meitheal 25 vials AP FDA listed
Heparin Sodium 1000 [USP'U]/mL 71872-7352-01 Medical 1 vial 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 65219-0066-10 Fresenius 25 vials AP FDA listed
Heparin Sodium 1000 [USP'U]/mL 68083-0427-25 Gland 25 vials AP 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 72603-0267-25 NorthStar 25 vials AP FDA listed
Heparin Sodium 1000 [USP'U]/mL 67457-0384-99 Mylan 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 72603-0179-25 NorthStar 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 71872-7364-01 Medical 1 vial AP FDA listed
Heparin Sodium 1000 [USP'U]/mL 81952-0112-06 Hepalink 25 vials AP FDA listed
Heparin Sodium 1000 [USP'U]/mL 55154-9583-05 Cardinal 5 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 71872-7365-01 Medical 1 vial AP FDA listed
Heparin Sodium 1000 [USP'U]/mL 72603-0234-25 NorthStar 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]/mL 67457-0372-99 Mylan 25 vials AP Discontinued
Heparin Sodium 1000 [USP'U]/mL 00409-2720-01 Hospira, 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 00404-9979-01 Henry 1 vial 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

🏛️
1972
On the market since
Feb 1972
📍
2026
Currently FDA-listed
54 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
63323-0276-02 You're viewing this 25 VIAL in 1 TRAY (63323-276-02) / 2 mL in 1 VIAL (63323-276-01) 2000-09-06 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) — 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 63323-276-02, 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: 63323-0276-02, written without dashes as 63323027602. 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 63323-0276-02, the first segment (63323) is the labeler code FDA assigned to Fresenius Kabi USA, LLC; the middle segment (0276) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Fresenius Kabi USA, 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.
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.

📄 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 107 words

INDICATIONS AND USAGE Heparin Sodium Injection is indicated for: Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease (see DOSAGE AND ADMINISTRATION ); Prophylaxis and treatment of pulmonary embolism; Atrial fibrillation with embolization; Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); Prevention of clotting in arterial and cardiac surgery; Prophylaxis and treatment of peripheral arterial embolism.

Heparin may also be employed as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures.

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Confirm the choice of the correct Heparin Sodium Injection vial prior to administration of the drug to a patient (see WARNINGS, Fatal Medication Errors ). The 1 mL vial must not be confused with a “catheter lock flush” vial or other 1 mL vial of inappropriate strength.

Confirm that you have selected the correct medication and strength prior to administration of the drug. 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. Heparin sodium is not effective by oral administration and should be given 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. The dosage of heparin sodium should be adjusted according to the patient’s coagulation test results. When heparin is given by continuous intravenous infusion, the coagulation time should be determined approximately every four hours in the early stages of treatment.

When the drug is administered intermittently by intravenous injection, coagulation tests should be performed before each injection during the early stages of treatment and at appropriate intervals thereafter. 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. After deep subcutaneous (intrafat) injections, tests for adequacy of dosage are best performed on samples drawn four to six hours after the injection.

Periodic platelet counts, hematocrits and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration. Converting to Oral Anticoagulant When an oral anticoagulant of the coumarin or similar type is to be begun in patients already receiving heparin sodium, baseline and subsequent tests of prothrombin activity must be determined at a time when heparin activity is too low to affect the prothrombin time. This is about five hours after the last IV bolus and 24 hours after the last subcutaneous dose.

If continuous IV heparin infusion is used, prothrombin time can usually be measured at any time. In converting from heparin to an oral anticoagulant, the dose of the oral anticoagulant should be the usual initial amount and thereafter prothrombin time should be determined at the usual intervals. To ensure continuous anticoagulation, it is advisable to continue full heparin therapy for several days after the prothrombin time has reached the therapeutic range.

Heparin therapy may then be discontinued without tapering. Therapeutic Anticoagulant Effect with Full-Dose Heparin Although dosage must be adjusted for the individual patient according to the results of suitable laboratory tests, the following dosage schedules may be used as guidelines: METHOD OF ADMINISTRATION FREQUENCY RECOMMENDED DOSE (based on 150 lb [68 kg] patient) Deep Subcutaneous (Intrafat) Injection A different site should be used for each injection to prevent the development of massive hematoma Initial Dose 5,000 units by IV injection, followed by 10,000 to 20,000 units of a concentrated solution, subcutaneously Every 8 hours 8,000 to 10,000 units of a concentrated solution or Every 12 hours 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% Sodi…

Contraindications 73 words

CONTRAINDICATIONS Heparin sodium should NOT be used in patients with the following conditions: Severe thrombocytopenia; When 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 uncontrollable active bleeding state (see WARNINGS ), except when this is due to disseminated intravascular coagulation.

⚠️ Warnings ~2 min read

WARNINGS Heparin is not intended for intramuscular use. Fatal 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. Benzyl Alcohol Toxicity Use preservative-free HEPARIN SODIUM INJECTION in neonates and infants.

The preservative benzyl alcohol has been associated with serious adverse events and death in pediatric patients. The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birth weight infants may be more likely to develop toxicity (see PRECAUTIONS, Pediatric Use ).

Hypersensitivity Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations (see ADVERSE REACTIONS, Hypersensitivity ). Hemorrhage Hemorrhage can occur at virtually any site in patients receiving heparin. An unexplained fall in hematocrit, fall in blood pressure or any other unexplained symptom should lead to serious consideration of a hemorrhagic event.

Heparin sodium should be used with extreme caution in disease states in which there is increased danger of hemorrhage. Some of the conditions in which increased danger of hemorrhage exists are: 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. Gastrointestinal —Ulcerative lesions and continuous tube drainage of the stomach or small intestine. Other —Menstruation, liver disease with impaired hemostasis.

Coagulation Testing When heparin sodium is administered in therapeutic amounts, its dosage should be regulated by frequent blood coagulation tests. If the coagulation test is unduly prolonged or if hemorrhage occurs, heparin sodium should be promptly discontinued (see OVERDOSAGE ). Thrombocytopenia Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of up to 30%.

Platelet counts should be obtained at baseline and periodically during heparin administration. Mild thrombocytopenia (count greater than 100,000/mm 3 ) may remain stable or reverse even if heparin is continued. However, thrombocytopenia of any degree should be monitored closely.

If the count falls below 100,000/mm 3 or if recurrent thrombosis develops (see Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis ), the heparin product should be discontinued, and, if necessary, an alternative anticoagulant administered. Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT) Heparin-induced Thrombocytopenia (HIT) is a serious antibody-mediated reaction resulting from irreversible aggregation of platelets. HIT may progress to the development of venous and arterial thromboses, a condition referred to as Heparin-induced Thrombocytopenia and 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. Thrombocytopenia of any degree should be monitored closely.

If the platelet count falls below 100,000/mm 3 or if recurre…

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS Hemorrhage Hemorrhage is the chief complication that may result from heparin therapy (see WARNINGS ). An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug (see OVERDOSAGE ). It should be appreciated that 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: (a) Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred during anticoagulant therapy. Therefore, such treatment should be discontinued in patients who develop signs and symptoms of acute adrenal hemorrhage and insufficiency. Initiation of corrective therapy should not depend on laboratory confirmation of the diagnosis, since any delay in an acute situation may result in the patient’s death.

(b) Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term anticoagulant therapy. This complication, if unrecognized, may be fatal. (c) Retroperitoneal hemorrhage.

Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT) and Delayed Onset of HIT and HITT See WARNINGS . Local Irritation Local irritation, erythema, mild pain, hematoma or ulceration may follow deep subcutaneous (intrafat) injection of heparin sodium. These complications are much more common after intramuscular use, and such use is not recommended.

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 more rarely. Itching and burning, especially on the plantar side of the feet, may occur (see WARNINGS and PRECAUTIONS ). Certain episodes of painful, ischemic and cyanosed limbs have in the past been attributed to allergic vasospastic reactions.

Whether these are in fact identical to the thrombocytopenia-associated complications, remains to be determined. Miscellaneous Osteoporosis following long-term administration of high doses of heparin, cutaneous necrosis after systemic administration, suppression of aldosterone synthesis, delayed transient alopecia, priapism, and rebound hyperlipemia on discontinuation of heparin sodium have also been reported. Significant elevations of aminotransferase (SGOT [S-AST] and SGPT [S-ALT]) levels have occurred in a high percentage of patients (and healthy subjects) who have received heparin.

Hemorrhage Hemorrhage is the chief complication that may result from heparin therapy (see WARNINGS ). An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug (see OVERDOSAGE ). It should be appreciated that 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: (a) Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred during anticoagulant therapy. Therefore, such treatment should be discontinued in patients who develop signs and symptoms of acute adrenal hemorrhage and insufficiency. Initiation of corrective therapy should not depend on laboratory confirmation of the diagnosis, since any delay in an acute situation may result in the patient’s death.

(b) Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term anticoagulant therapy. This complication, if unrecognized, may be fatal. (c) Retroperitoneal hemorrhage.

Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT) and Delayed Onset of HIT and HITT See WARNINGS .

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🆘 Overdosage ~2 min read

OVERDOSAGE Symptoms Bleeding is the chief sign of heparin overdosage. Nosebleeds, blood in urine or tarry stools may be noted as the first sign of bleeding. Easy bruising or petechial formations may precede frank bleeding.

Treatment Neutralization of Heparin Effect —When clinical circumstances (bleeding) require reversal of heparinization, 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. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions.

Because fatal reactions often resembling anaphylaxis have been reported, the drug 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, USP products.

Symptoms Bleeding is the chief sign of heparin overdosage. Nosebleeds, blood in urine or tarry stools may be noted as the first sign of bleeding. Easy bruising or petechial formations may precede frank bleeding.

Treatment Neutralization of Heparin Effect —When clinical circumstances (bleeding) require reversal of heparinization, 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. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions.

Because fatal reactions often resembling anaphylaxis have been reported, the drug 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, USP products.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in vivo . Heparin acts at multiple sites in the normal coagulation system. Small amounts of heparin in combination with antithrombin III (heparin cofactor) can inhibit thrombosis by inactivating activated Factor X and inhibiting the conversion of prothrombin to thrombin.

Once active thrombosis has developed, larger amounts of heparin can inhibit further coagulation by inactivating thrombin and preventing the conversion of fibrinogen to fibrin. Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor. Bleeding time is usually unaffected by heparin.

Clotting time is prolonged by full therapeutic doses of heparin; in most cases, it is not measurably affected by low doses of heparin. 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. Peak plasma levels of heparin are achieved two to four hours following subcutaneous administration, although there are considerable individual variations.

Loglinear plots of heparin plasma concentrations with time, for a wide range of dose levels, are linear, which suggests the absence of zero order processes. Liver and the reticuloendothelial system are the sites of biotransformation. The biphasic elimination curve, a rapidly declining alpha phase (t 1⁄2 = 10 minutes) and after the age of 40 a slower beta phase, indicates uptake in organs.

The absence of a relationship between anticoagulant half-life and concentration half-life may reflect factors such as protein binding of heparin. Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots.

📦 How Supplied / Storage and Handling ~2 min read

HOW SUPPLIED Heparin Sodium Injection, USP (porcine), preservative free , is available as follows: Product No. NDC No. Strength Fill Volume 27602 63323-276-02 2,000 USP Heparin units per 2 mL (1,000 USP Heparin units per mL) 2 mL fill in a 2 mL single dose, flip-top vial, in packages of 25.

504302 63323-543-02 5,000 USP Heparin units per 0.5 mL 0.5 mL fill in a 2 mL single dose, flip-top vial, in packages of 25. Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate.

Discard unused portion. This container closure is not made from natural rubber latex. Heparin Sodium Injection, USP (porcine) contains benzyl alcohol and is available as follows: Product No.

NDC No. Strength Fill Volume 4710 63323-047-10 50,000 USP Heparin units per 10 mL (5,000 USP Heparin units per mL) 10 mL fill in a 10 mL multi-dose, flip-top vial, in packages of 25. 504509 63323-459-09 40,000 USP Heparin units per 4 mL (10,000 USP Heparin units per mL) 4 mL fill in a 5 mL multi-dose, flip-top vial, in packages of 25.

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 from natural rubber latex.

Heparin Sodium Injection, USP (porcine) contains parabens and is available in multi-dose, flip-top vials, in packages of 25, as follows: Product No. NDC No. Strength Fill Volume 504001* 63323-540-01 1,000 USP Heparin units per 1 mL 1 mL fill in a 3 mL vial.

504011 63323-540-11 10,000 USP Heparin units per 10 mL (1,000 USP Heparin units per mL) 10 mL fill in a 10 mL vial. 504031 63323-540-31 30,000 USP Heparin units per 30 mL (1,000 USP Heparin units per mL) 30 mL fill in a 30 mL vial. 926201** 63323-262-01 5,000 USP Heparin units per 1 mL 1 mL fill in a 3 mL vial.

504201* 63323-542-01 10,000 USP Heparin units per 1 mL 1 mL fill in a 3 mL vial. 504207 63323-542-07 50,000 USP Heparin units per 5 mL (10,000 USP Heparin units per mL) 5 mL fill in a 6 mL vial. 915501** 63323-915-01 20,000 USP Heparin units per 1 mL 1 mL fill in a 3 mL vial. *Packaged in a plastic or glass vial. **Packaged in a plastic vial.

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 from natural rubber latex.

📋 Description ~2 min read

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) ß-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). structure

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