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Enoxaparin Sodium 100 mg/mL Injection — NDC 63323-0586-96 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Enoxaparin Sodium 100 mg/mL Injection — NDC 63323-586-96 (Billing 63323-0586-96)

by Fresenius Kabi USA, LLC · 10 BLISTER PACK in 1 CARTON / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE

This is a package of Enoxaparin Sodium 100 mg/mL Injection from Fresenius Kabi USA, LLC, marketed since Apr 2019 and currently FDA-listed; retail pharmacies pay about $6.45 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 63323-0586-96
🏷️ FDA NDC (as labeled) 63323-586-96 billing pads the product segment with a zero
This package
Contains1 mL in 1 syringe Cost per mL$6.45 NADAC Per package$64.52 / 10 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $7.56/unit · Part D plans $10.33/unit — full pricing hub ↓
Main listing for product 63323-586 · Also comes in: 1 mL 63323-586-65
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 2, 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 Enoxaparin 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 II · Aug 5, 2025 — Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL (Cardinal Health Inc.) · FDA recall D-0597-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-586-96
Product NDC 63323-586
11-digit billing NDC 63323058696
NCPDP billing unit ML — per mL (volume)
RxCUI 854228, 854235, 854238, 854241, 854245, 854248, 854252
UNII 8NZ41MIK1O
Application # ANDA078990
SPL Set ID c3be543e-8aff-4311-bf77-e7a5a814ca6f
Established class (EPC) Heparin; Low Molecular Weight Heparin
Chemical class Low-Molecular-Weight
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-04-23
Route SUBCUTANEOUS
Dosage form INJECTION
Substance ENOXAPARIN SODIUM
TE code (Orange Book) AP · RLD · RS

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

GPI-14 8310102010E540
GPI class Enoxaparin Sodium
GCN Seq No 027995
GCN 62773
HICL code 007878
Ingredient (HICL) Enoxaparin Sodium
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 ENOXAPARIN 100 MG/ML SYRINGE
FDB brand name Enoxaparin Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 027995
  • GCN: 62773
  • GPI-14 (Medi-Span): 8310102010E540
  • HICL (First Databank): 007878
  • AHFS class code: 20:12.04.16
  • RxCUI (RxNorm): 854228
Why two NDCs? The FDA registers this code as 63323-586-96 — 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 → 63323-0586-96. 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 Low Molecular Weight Heparin class.

Pharmacologic class Low Molecular Weight Heparin
Drug family (ATC) Heparin group
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ENOXAPARIN 100 MG/ML SYRINGE Ingredient Enoxaparin Sodium
📗 Our plain-language guide HelloPharmacist
  • It is a blood thinner that helps prevent and treat deep vein thrombosis, a clot in a deep vein. It is also used in unstable angina and certain heart attacks. Your prescriber choose...
  • It is an injection, usually under the skin, and some uses involve an injection into a vein. How often depends on why you need it. Follow your prescriber’s directions and the produc...
  • Bruising, injection site pain, nausea and diarrhea are common. Some people have bleeding or a lower blood count. Call your doctor if bleeding seems unusual or won’t stop.
  • Yes. If you have an epidural or spinal procedure, bleeding near the spine can rarely cause permanent paralysis. Report new numbness, leg weakness or bladder or bowel changes right...
📖 Read our full Enoxaparin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

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

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

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $6.452 $64.52 / 10 ml
Medicaid paysCMS SDUD · 12 mo $7.56 $75.58 / 10 ml
Medicare drug plans payPart D · Q2 2026 $10.33 $103.33 / 10 ml
Medicare Part B allowsASP · J1650 $0.536 / J1650 unit —
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $12.629 $6.452
▼ Down 35% over the last 24 months.
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)63323-586-96
11-digit billing NDC63323-0586-96
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1650
DescriptorINJECTION, ENOXAPARIN SODIUM, 10 MG
Billing units / pkg10 units
How the units are derivedThis package is 1 ML; the HCPCS unit is 10 MG, so one package = 10 billing units.
Medicare Part B spend (2026 (Q1))$24,269 · 288 claims · $84.27 per claim (all NDCs under J1650)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
63323-0586-65 63323-586-65 10 BLISTER PACK in 1 CARTON / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE $6.45 / mL $64.52 2019-04-23 — Active
63323-0586-96 You're viewing this Main listing 10 BLISTER PACK in 1 CARTON / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE $6.45 / mL $64.52 2019-04-23 — Active

This pack effectively ties for the lowest per-mL cost of the 2 priced pack sizes ($6.45 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 blister pack in 1 carton / 1 syringe in 1 blister pack / 1 ml in 1 syringe.
What NDC number is used to bill for this package of Enoxaparin Sodium 100 mg/mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Enoxaparin Sodium 100 mg/mL 00548-5605-00 Amphastar 10 syringes $6.452 AP Availability likely —
Enoxaparin Sodium 100 mg/mL 00781-3268-69 Sandoz 10 syringes $6.452 AP Availability likely —
Enoxaparin sodium 100 mg/mL 00955-1010-10 Sanofi-Aventis 10 cellos $6.452 AP Availability likely —
Enoxaparin Sodium 100 mg/mL 16714-0046-10 NorthStar 10 syringes $6.452 AP Availability likely —
Enoxaparin Sodium 100 mg/mLthis 63323-0586-96 Fresenius 1 syringe $6.452 AP Availability likely —
Enoxaparin Sodium 100 mg/mL 68001-0637-42 BluePoint 10 syringes $6.452 AP Availability likely —
Enoxaparin Sodium 100 mg/mL 70710-1761-06 Zydus 10 syringes $6.452 AP Availability likely —
Enoxaparin Sodium 100 mg/mL 71288-0436-92 Meitheal 10 syringes $6.452 AP Availability likely —
enoxaparin sodium 100 mg/mL 71839-0113-10 BE 10 syringes $6.452 AP Availability likely —
Enoxaparin Sodium 100 mg/mL 81952-0130-06 Hepalink 10 syringes $6.452 AP Availability likely —
Enoxaparin Sodium 100 mg/mL 63323-0605-94 Fresenius 10 cellos $6.593 AP Availability likely +2%
Enoxaparin Sodium 100 mg/mL 00781-3262-68 Sandoz 10 syringes $6.687 AP Availability likely +4%
Enoxaparin Sodium 100 mg/mL 68001-0636-42 BluePoint 10 syringes $6.687 AP Availability likely +4%
Enoxaparin Sodium 100 mg/mL 71288-0435-92 Meitheal 10 syringes $6.687 AP Availability likely +4%
Enoxaparin Sodium 100 mg/mL 00548-5604-00 Amphastar 10 syringes $6.687 AP Availability likely +4%
Enoxaparin Sodium 100 mg/mL 16714-0036-10 NorthStar 10 syringes $6.687 AP Availability likely +4%
Enoxaparin Sodium 100 mg/mL 68001-0460-42 BluePoint 10 syringes $7.127 AP Availability likely +10%
Enoxaparin Sodium 100 mg/mL 68001-0461-42 BluePoint 10 syringes $7.370 AP Availability likely +14%
Enoxaparin Sodium 100 mg/mL 68001-0459-42 BluePoint 10 syringes $7.452 AP Availability likely +16%
Enoxaparin Sodium 100 mg/mL 00548-5603-00 Amphastar 10 syringes $7.452 AP Availability likely +16%
Enoxaparin Sodium 100 mg/mL 16714-0026-10 NorthStar 10 syringes $7.452 AP Availability likely +16%
Enoxaparin Sodium 100 mg/mL 00781-3256-66 Sandoz 10 syringes $7.452 AP Availability likely +16%
Enoxaparin Sodium 100 mg/mL 68001-0635-42 BluePoint 10 syringes $7.452 AP Availability likely +16%
Enoxaparin Sodium 100 mg/mL 71288-0434-92 Meitheal 10 syringes $7.452 AP Availability likely +16%
Enoxaparin Sodium 100 mg/mL 68001-0458-42 BluePoint 10 syringes $7.779 AP Availability likely +21%
Enoxaparin Sodium 100 mg/mL 71288-0433-92 Meitheal 10 syringes $7.779 AP Availability likely +21%
Enoxaparin Sodium 100 mg/mL 00781-3246-64 Sandoz 10 syringes $7.779 AP Availability likely +21%
Enoxaparin Sodium 100 mg/mL 68001-0634-42 BluePoint 10 syringes $7.779 AP Availability likely +21%
Enoxaparin Sodium 100 mg/mL 00548-5602-00 Amphastar 10 syringes $7.779 AP Availability likely +21%
Enoxaparin Sodium 100 mg/mL 16714-0016-10 NorthStar 10 syringes $7.779 AP Availability likely +21%
Enoxaparin Sodium 100 mg/mL 25021-0410-70 Sagent 10 syringes $9.127 AP Availability likely +41%
Enoxaparin Sodium 100 mg/mL 68001-0457-42 BluePoint 10 syringes $9.127 AP Availability likely +41%
Enoxaparin Sodium 100 mg/mL 71288-0432-92 Meitheal 10 syringes $9.127 AP Availability likely +41%
Enoxaparin Sodium 100 mg/mL 00548-5601-00 Amphastar 10 syringes $9.127 AP Availability likely +41%
Enoxaparin Sodium 100 mg/mL 16714-0006-10 NorthStar 10 syringes $9.127 AP Availability likely +41%
Enoxaparin Sodium 100 mg/mL 68001-0633-42 BluePoint 10 syringes $9.127 AP Availability likely +41%
Enoxaparin Sodium 100 mg/mL 00781-3238-63 Sandoz 10 syringes $9.127 AP Availability likely +41%
Enoxaparin Sodium 100 mg/mL 72603-0205-10 NorthStar 10 syringes $9.666 AP FDA listed +50%
Lovenox 100 mg/mL 00075-0623-00 Sanofi-Aventis 10 cellos — AP FDA listed —
Lovenox 100 mg/mL 00075-8020-10 Sanofi-Aventis 10 cellos — AP FDA listed —
Enoxaparin Sodium 100 mg/mL 11797-0761-06 Italfarmaco 10 syringes — AP FDA listed —
enoxaparin sodium 100 mg/mL 28955-0105-10 Hebei 10 syringes — AP FDA listed —
Enoxaparin Sodium 100 mg/mL 55154-3544-05 Cardinal 5 syringes — AP FDA listed —
Enoxaparin Sodium 100 mg/mL 68083-0638-10 Gland 10 syringes — AP FDA listed —
Enoxaparin Sodium 100 mg/mL 72572-0280-10 Civica, 10 syringes — AP FDA listed —
Enoxaparin Sodium 100 mg/mL 55154-3540-05 Cardinal 5 syringes — AP FDA listed —
Enoxaparin Sodium 100 mg/mL 55154-3542-05 Cardinal 5 syringes — AP FDA listed —
Enoxaparin Sodium 100 mg/mL 55154-3543-05 Cardinal 5 syringes — AP FDA listed —
Enoxaparin Sodium 100 mg/mL 55154-3541-05 Cardinal 5 syringes — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

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

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

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

Inactive Ingredients / Excipients

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

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

  • UNII 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderGLAND PHARMA LTD
FDA applicationANDA078990 (ANDA)
Labeler code63323
First marketedApr 2019
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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 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 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: SPINAL/ EPIDURAL HEMATOMAS Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.

Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • Use of indwelling epidural catheters • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, and other anticoagulants • A history of traumatic or repeated epidural or spinal punctures • A history of spinal deformity or spinal surgery • Optimal timing between the administration of enoxaparin sodium injection and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment.

If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [ see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7 ) ]. WARNING: SPINAL/EPIDURAL HEMATOMAS See full prescribing information for complete boxed warning.

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.

Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • Use of indwelling epidural catheters • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, and other anticoagulants • A history of traumatic or repeated epidural or spinal punctures • A history of spinal deformity or spinal surgery • Optimal timing between the administration of enoxaparin sodium injection and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment.

If neurological compromise is noted, urgent treatment is necessary. ( 5.1 , 7 )

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Enoxaparin sodium injection is a low molecular weight heparin [LMWH] indicated for: • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness ( 1.1 ) • Inpatient treatment of acute DVT with or without pulmonary embolism ( 1.2 ) • Outpatient treatment of acute DVT without pulmonary embolism ( 1.2 ) • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction [MI] ( 1.3 ) • Treatment of acute ST-segment elevation myocardial infarction [STEMI] managed medically or with subsequent percutaneous coronary intervention [PCI] ( 1.4 )

1.1Prophylaxis of Deep Vein Thrombosis Enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): • in patients undergoing abdominal surgery who are at risk for thromboembolic complications [ see Clinical Studies ( 14.1 ) ] • in patients undergoing hip replacement surgery, during and following hospitalization • in patients undergoing knee replacement surgery • in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness

1.2Treatment of Acute Deep Vein Thrombosis Enoxaparin sodium injection is indicated for: • the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium • the outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium

1.3Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction Enoxaparin sodium injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.

1.4Treatment of Acute ST-Segment Elevation Myocardial Infarction Enoxaparin sodium injection, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION See full prescribing information for dosing and administration information. ( 2 )

2.1Pretreatment Evaluation Evaluate all patients for a bleeding disorder before starting enoxaparin sodium injection treatment, unless treatment is urgently needed.

2.2Adult Dosage Abdominal Surgery The recommended dose of enoxaparin sodium injection is 40 mg by subcutaneous injection once a day (with the initial dose given 2 hours prior to surgery) in patients undergoing abdominal surgery who are at risk for thromboembolic complications. The usual duration of administration is 7 to 10 days [see Clinical Studies ( 14.1 )]. Hip or Knee Replacement Surgery The recommended dose of enoxaparin sodium injection is 30 mg every 12 hours administered by subcutaneous injection in patients undergoing hip or knee replacement surgery.

Administer the initial dose 12 to 24 hours after surgery, provided that hemostasis has been established. The usual duration of administration is 7 to 10 days [see Clinical Studies ( 14.2 )]. A dose of enoxaparin sodium injection of 40 mg once a day subcutaneously may be considered for hip replacement surgery for up to 3 weeks.

Administer the initial dose 12 (±3) hours prior to surgery. Medical Patients during Acute Illness The recommended dose of enoxaparin sodium injection is 40 mg once a day administered by subcutaneous injection for medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness. The usual duration of administration is 6 to 11 days [see Clinical Studies ( 14.3 )].

Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism The recommended dose of enoxaparin sodium injection is 1 mg/kg every 12 hours administered subcutaneously in patients with acute deep vein thrombosis without pulmonary embolism, who can be treated at home in an outpatient setting. The recommended dose of enoxaparin sodium injection is 1 mg/kg every 12 hours administered subcutaneously or 1.5 mg/kg once a day administered subcutaneously at the same time every day for inpatient (hospital) treatment of patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment).

In both outpatient and inpatient (hospital) treatments, initiate warfarin sodium therapy when appropriate (usually within 72 hours of enoxaparin sodium injection). Continue enoxaparin sodium injection for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2 to 3). The average duration of administration is 7 days [see Clinical Studies ( 14.4 )].

Unstable Angina and Non-Q-Wave Myocardial Infarction The recommended dose of enoxaparin sodium injection is 1 mg/kg administered subcutaneously every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily) in patients with unstable angina or non–Q-wave myocardial infarction. Treat with enoxaparin sodium injection for a minimum of 2 days and continue until clinical stabilization. The usual duration of treatment is 2 to 8 days [ see Warnings and Precautions ( 5.2 ) and Clinical Studies ( 14.5 ) ].

Treatment of Acute ST-Segment Elevation Myocardial Infarction The recommended dose of enoxaparin sodium injection is a single intravenous bolus of 30 mg plus a 1 mg/kg subcutaneous dose followed by 1 mg/kg administered subcutaneously every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses) in patients with acute ST-segment elevation myocardial infarction. Reduce the dosage in patients ≥75 years of age [see Dosage and Administration ( 2.4 )] . Unless contraindicated, administer aspirin to all patients as soon as they are identified as having STEMI and continue dosing with 75 to 325 mg once daily.

When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific), adminis… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 105 words ▾

3 DOSAGE FORMS AND STRENGTHS Enoxaparin sodium injection, USP is a clear, colorless to pale-yellow sterile solution available in two concentrations. 100 mg/mL Concentration - Single-dose Prefilled Syringes 30 mg/0.3 mL, 40 mg/0.4 mL - Single-dose Graduated Prefilled Syringes 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/mL 150 mg/mL Concentration - Single-dose Graduated Prefilled Syringes 120 mg/0.8 mL, 150 mg/mL 100 mg/mL concentration ( 3 ): • Single-dose prefilled syringes: 30 mg/0.3 mL, 40 mg/0.4 mL • Single-dose graduated prefilled syringes: 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/mL 150 mg/mL concentration ( 3 ): • Single-dose graduated prefilled syringes: 120 mg/0.8 mL, 150 mg/mL

⛔ Contraindications 114 words ▾

4 CONTRAINDICATIONS Enoxaparin sodium injection is contraindicated in patients with: • Active major bleeding • History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies [see Warnings and Precautions ( 5.4 )] • Known hypersensitivity to enoxaparin sodium ( e.g., pruritus, urticaria, anaphylactic/anaphylactoid reactions) [ see Adverse Reactions ( 6.2 ) ] • Known hypersensitivity to heparin or pork products • Active major bleeding ( 4 ) • History of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies ( 4 ) • Hypersensitivity to enoxaparin sodium ( 4 ) • Hypersensitivity to heparin or pork products ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Increased Risk of Hemorrhage: Monitor for sign of bleeding ( 5.1 , 5.2 , 5.3 ) • Risk of Heparin-Induced Thrombocytopenia with or without Thrombosis. ( 5.4 ) • Thrombocytopenia: Monitor platelet count closely. ( 5.5 ) • Interchangeability with other heparins: Do not exchange with heparin or other LMWHs ( 5.6 ) • Increased Risk of Thrombosis in Pregnant Women with Mechanical Prosthetic Heart Valves: Women and their fetuses may be at increased risk.

Monitor more frequently and adjust dosage as needed. ( 5.7 )

5.1Increased Risk of Hemorrhage Cases of epidural or spinal hemorrhage and subsequent hematomas have been reported with the use of enoxaparin sodium injection and epidural or spinal anesthesia/analgesia or spinal puncture procedures, resulting in long-term or permanent paralysis. The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting hemostasis such as NSAIDs, with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity [ see Boxed Warning , Adverse Reactions ( 6.2 ) and Drug Interactions ( 7 ) ].

To reduce the potential risk of bleeding associated with the concurrent use of enoxaparin sodium injection and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of enoxaparin [ see Clinical Pharmacology ( 12.3 ) ]. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of enoxaparin is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known. Placement or removal of a catheter should be delayed for at least 12 hours after administration of lower doses (30 mg once or twice daily or 40 mg once daily) of enoxaparin sodium injection and at least 24 hours after the administration of higher doses (0.75 mg/kg twice-daily, 1 mg/kg twice-daily, or 1.5 mg/kg once daily) of enoxaparin sodium injection.

Anti-Xa levels are still detectable at these time points, and these delays are not a guarantee that neuraxial hematoma will be avoided. Patients receiving the 0.75 mg/kg twice daily dose, or the 1 mg/kg twice-daily dose should not receive the second enoxaparin dose in the twice daily regimen to allow a longer delay before catheter placement or removal. Likewise, although a specific recommendation for timing of a subsequent enoxaparin sodium injection dose after catheter removal cannot be made, consider delaying this next dose for at least four hours, based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.

For patients with creatinine clearance <30 mL/minute, additional considerations are necessary because elimination of enoxaparin is more prolonged; consider doubling the timing of removal of a catheter, at least 24 hours for the lower prescribed dose of enoxaparin sodium injection (30 mg once daily) and at least 48 hours for the higher dose (1 mg/kg/day) [ see Clinical Pharmacology ( 12.3 ) ]. Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia/analgesia or lumbar puncture, frequent monitoring must be exercised to detect any signs and symptoms of neurological impairment such as midline back pain, sensory and motor deficits (numbness or weakness in lower limbs), and bowel and/or bladder dysfunction.

Instruct patients to report immediately if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae. Use enoxaparin sodium injection with extreme caution in conditions with increased risk of hemorrhage, such as bacterial endocarditis, cong… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are also discussed in other sections of the labeling: • Spinal/epidural hematomas [ see Boxed Warning and Warnings and Precautions ( 5.1 ) ] • Increased Risk of Hemorrhage [ see Warnings and Precautions ( 5.1 ) ] • Thrombocytopenia [ see Warnings and Precautions ( 5.5 ) ] Most common adverse reactions (>1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, nausea, ecchymosis, fever, edema, peripheral edema, dyspnea, confusion, and injection site pain ( 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

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During clinical development for the approved indications, 15,918 patients were exposed to enoxaparin sodium. These included 1,228 for prophylaxis of deep vein thrombosis following abdominal surgery in patients at risk for thromboembolic complications, 1,368 for prophylaxis of deep vein thrombosis following hip or knee replacement surgery, 711 for prophylaxis of deep vein thrombosis in medical patients with severely restricted mobility during acute illness, 1,578 for prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, 10,176 for treatment of acute ST-elevation myocardial infarction, and 857 for treatment of deep vein thrombosis with or without pulmonary embolism.

Enoxaparin sodium doses in the clinical trials for prophylaxis of deep vein thrombosis following abdominal or hip or knee replacement surgery or in medical patients with severely restricted mobility during acute illness ranged from 40 mg subcutaneously once daily to 30 mg subcutaneously twice daily. In the clinical studies for prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction doses were 1 mg/kg every 12 hours and in the clinical studies for treatment of acute ST-segment elevation myocardial infarction enoxaparin sodium doses were a 30 mg intravenous bolus followed by 1 mg/kg every 12 hours subcutaneously.

Hemorrhage The following rates of major bleeding events have been reported during clinical trials with enoxaparin sodium injection [see Tables 2 to 7 ]. Table 2 Major Bleeding Episodes following Abdominal and Colorectal Surgery* * Bleeding complications were considered major: (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease ≥ 2 g/dL or transfusion of 2 or more units of blood products. Retroperitoneal, intraocular, and intracranial hemorrhages were always considered major.

Dosing Regimen Indications Enoxaparin Sodium Injection 40 mg daily subcutaneously Heparin 5000 U q8h subcutaneously Abdominal Surgery n = 555 23 (4%) n = 560 16 (3%) Colorectal Surgery n = 673 28 (4%) n = 674 21 (3%) Table 3 Major Bleeding Episodes following Hip or Knee Replacement Surgery* *Bleeding complications were considered major: (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease ≥ 2 g/dL or transfusion of 2 or more units of blood products. Retroperitoneal and intracranial hemorrhages were always considered major.

In the knee replacement surgery trials, intraocular hemorrhages were also considered major hemorrhages. † Enoxaparin sodium injection 30 mg every 12 hours subcutaneously initiated 12 to 24 hours after surgery and continued for up to 14 days after surgery ‡ Enoxaparin sodium injection 40 mg subcutaneously once a day initiated up to 12 hours prior to surgery and continued for up to 7 days after surgery § Enoxaparin sodium injection 40 mg subcutaneously once a day for up to 21 days after discharge Indicatio… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 89 words ▾

7 DRUG INTERACTIONS Whenever possible, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of enoxaparin sodium injection therapy. These agents include medications such as: anticoagulants, platelet inhibitors including acetylsalicylic acid, salicylates, NSAIDs (including ketorolac tromethamine), dipyridamole, or sulfinpyrazone. If coadministration is essential, conduct close clinical and laboratory monitoring [ see Warnings and Precautions ( 5.1 ) ].

Discontinue agents which may enhance hemorrhage risk prior to initiation of enoxaparin sodium injection or conduct close clinical and laboratory monitoring ( 2.6 , 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Severe Renal Impairment: Adjust dose for patients with creatinine clearance <30 mL/min ( 2.3 , 8.7 ) • Geriatric Patients: Monitor for increased risk of bleeding ( 8.5 ) • Low-Weight Patients: Observe for signs of bleeding ( 8.8 )

8.1Pregnancy Risk Summary Placental transfer of enoxaparin was observed in the animal studies. Human data from a retrospective cohort study, which included 693 live births, suggest that enoxaparin does not increase the risk of major developmental abnormalities (see Data ) . Based on animal data, enoxaparin sodium injection is not predicted to increase the risk of major developmental abnormalities (see Data ).

Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Pregnancy alone confers an increased risk for thromboembolism that is even higher for women with thromboembolic disease and certain high-risk pregnancy conditions. While not adequately studied, pregnant women with mechanical prosthetic heart valves may be at even higher risk for thrombosis [ see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.6 ) ]. Pregnant women with thromboembolic disease, including those with mechanical prosthetic heart valves and those with inherited or acquired thrombophilias, have an increased risk of other maternal complications and fetal loss regardless of the type of anticoagulant used.

All patients receiving anticoagulants, including pregnant women, are at risk for bleeding. Pregnant women receiving enoxaparin sodium injection should be carefully monitored for evidence of bleeding or excessive anticoagulation. Consideration for use of a shorter acting anticoagulant should be specifically addressed as delivery approaches [ see Boxed Warning ].

Hemorrhage can occur at any site and may lead to death of mother and/or fetus. Pregnant women should be apprised of the potential hazard to the fetus and the mother if enoxaparin sodium injection is administered during pregnancy. It is not known if monitoring of anti-Factor Xa activity and dose adjustment (by weight or anti-Factor Xa activity) of enoxaparin sodium injection affect the safety and the efficacy of the drug during pregnancy.

Data • Human Data - There are no adequate and well-controlled studies in pregnant women. A retrospective study reviewed the records of 604 women who used enoxaparin sodium injection during pregnancy. A total of 624 pregnancies resulted in 693 live births.

There were 72 hemorrhagic events (11 serious) in 63 women. There were 14 cases of neonatal hemorrhage. Major congenital anomalies in live births occurred at rates (2.5%) similar to background rates.

There have been postmarketing reports of fetal death when pregnant women received enoxaparin sodium injection. Causality for these cases has not been determined. Insufficient data, the underlying disease, and the possibility of inadequate anticoagulation complicate the evaluation of these cases.

A clinical study using enoxaparin sodium injection in pregnant women with mechanical prosthetic heart valves has been conducted [ see Warnings and Precautions ( 5.7 ) ] . • Animal Data - Teratology studies have been conducted in pregnant rats and rabbits at subcutaneous doses of enoxaparin up to 15 times the recommended human dose (by comparison with 2 mg/kg as the maximum recommended daily dose). There was no evidence of teratogenic effects or fetotoxicity due to enoxaparin. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

8.2Lactation Risk Summary It is unknown whether enoxaparin sodium injection i… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Placental transfer of enoxaparin was observed in the animal studies. Human data from a retrospective cohort study, which included 693 live births, suggest that enoxaparin does not increase the risk of major developmental abnormalities (see Data ) . Based on animal data, enoxaparin sodium injection is not predicted to increase the risk of major developmental abnormalities (see Data ).

Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Pregnancy alone confers an increased risk for thromboembolism that is even higher for women with thromboembolic disease and certain high-risk pregnancy conditions. While not adequately studied, pregnant women with mechanical prosthetic heart valves may be at even higher risk for thrombosis [ see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.6 ) ]. Pregnant women with thromboembolic disease, including those with mechanical prosthetic heart valves and those with inherited or acquired thrombophilias, have an increased risk of other maternal complications and fetal loss regardless of the type of anticoagulant used.

All patients receiving anticoagulants, including pregnant women, are at risk for bleeding. Pregnant women receiving enoxaparin sodium injection should be carefully monitored for evidence of bleeding or excessive anticoagulation. Consideration for use of a shorter acting anticoagulant should be specifically addressed as delivery approaches [ see Boxed Warning ].

Hemorrhage can occur at any site and may lead to death of mother and/or fetus. Pregnant women should be apprised of the potential hazard to the fetus and the mother if enoxaparin sodium injection is administered during pregnancy. It is not known if monitoring of anti-Factor Xa activity and dose adjustment (by weight or anti-Factor Xa activity) of enoxaparin sodium injection affect the safety and the efficacy of the drug during pregnancy.

Data • Human Data - There are no adequate and well-controlled studies in pregnant women. A retrospective study reviewed the records of 604 women who used enoxaparin sodium injection during pregnancy. A total of 624 pregnancies resulted in 693 live births.

There were 72 hemorrhagic events (11 serious) in 63 women. There were 14 cases of neonatal hemorrhage. Major congenital anomalies in live births occurred at rates (2.5%) similar to background rates.

There have been postmarketing reports of fetal death when pregnant women received enoxaparin sodium injection. Causality for these cases has not been determined. Insufficient data, the underlying disease, and the possibility of inadequate anticoagulation complicate the evaluation of these cases.

A clinical study using enoxaparin sodium injection in pregnant women with mechanical prosthetic heart valves has been conducted [ see Warnings and Precautions ( 5.7 ) ] . • Animal Data - Teratology studies have been conducted in pregnant rats and rabbits at subcutaneous doses of enoxaparin up to 15 times the recommended human dose (by comparison with 2 mg/kg as the maximum recommended daily dose). There was no evidence of teratogenic effects or fetotoxicity due to enoxaparin. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 29 words ▾

8.4Pediatric Use Safety and effectiveness of enoxaparin sodium injection in pediatric patients have not been established. Enoxaparin sodium injection is not approved for use in neonates or infants.

🧓 Geriatric Use ~2 min read ▾

8.5Geriatric Use Prevention of Deep Vein Thrombosis in Hip, Knee and Abdominal Surgery; Treatment of Deep Vein Thrombosis, Prevention of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction Over 2800 patients, 65 years and older, have received enoxaparin sodium injection in clinical trials. The efficacy of enoxaparin sodium injection in the geriatric (≥65 years) was similar to that seen in younger patients (<65 years). The incidence of bleeding complications was similar between geriatric and younger patients when 30 mg every 12 hours or 40 mg once a day doses of enoxaparin sodium injection were employed.

The incidence of bleeding complications was higher in geriatric patients as compared to younger patients when enoxaparin sodium injection was administered at doses of 1.5 mg/kg once a day or 1 mg/kg every 12 hours. The risk of enoxaparin sodium injection-associated bleeding increased with age. Serious adverse events increased with age for patients receiving enoxaparin sodium injection.

Other clinical experience (including postmarketing surveillance and literature reports) has not revealed additional differences in the safety of enoxaparin sodium injection between geriatric and younger patients. Careful attention to dosing intervals and concomitant medications (especially antiplatelet medications) is advised. Enoxaparin sodium injection should be used with care in geriatric patients who may show delayed elimination of enoxaparin.

Monitoring of geriatric patients with low body weight (<45 kg) and those predisposed to decreased renal function should be considered [ see Warnings and Precautions ( 2.6 ) and Clinical Pharmacology ( 12.3 ) ]. Treatment of Acute ST-Segment Elevation Myocardial Infarction In the clinical study for treatment of acute ST-segment elevation myocardial infarction, there was no evidence of difference in efficacy between patients ≥75 years of age (n = 1241) and patients less than 75 years of age (n = 9015). Patients ≥75 years of age did not receive a 30 mg intravenous bolus prior to the normal dosage regimen and had their subcutaneous dose adjusted to 0.75 mg/kg every 12 hours [ see Dosage and Administration ( 2.4 ) ].

The incidence of bleeding complications was higher in patients ≥65 years of age as compared to younger patients (<65 years).

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Accidental overdosage following administration of enoxaparin sodium injection may lead to hemorrhagic complications. Injected enoxaparin sodium injection may be largely neutralized by the slow intravenous injection of protamine sulfate (1% solution). The dose of protamine sulfate should be equal to the dose of enoxaparin sodium injection injected: 1 mg protamine sulfate should be administered to neutralize 1 mg enoxaparin sodium injection if enoxaparin sodium was administered in the previous 8 hours.

An infusion of 0.5 mg protamine per 1 mg of enoxaparin sodium may be administered if enoxaparin sodium was administered greater than 8 hours previous to the protamine administration, or if it has been determined that a second dose of protamine is required. The second infusion of 0.5 mg protamine sulfate per 1 mg of enoxaparin sodium injection may be administered if the aPTT measured 2 to 4 hours after the first infusion remains prolonged. If at least 12 hours have elapsed since the last enoxaparin sodium injection, protamine administration may not be required; however, even with higher doses of protamine, the aPTT may remain more prolonged than following administration of heparin.

In all cases, the anti-Factor Xa activity is never completely neutralized (maximum about 60%). Particular care should be taken to avoid overdosage with protamine sulfate. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions.

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

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Enoxaparin is a low molecular weight heparin which has antithrombotic properties.

12.2Pharmacodynamics In humans, enoxaparin given at a dose of 1.5 mg/kg subcutaneously is characterized by a higher ratio of anti-Factor Xa to anti-Factor IIa activity (mean ± SD, 14.0 ± 3.1) (based on areas under anti-Factor activity versus time curves) compared to the ratios observed for heparin (mean ± SD, 1.22 ± 0.13). Increases of up to 1.8 times the control values were seen in the thrombin time (TT) and the activated partial thromboplastin time (aPTT). Enoxaparin at a 1 mg/kg dose (100 mg/mL concentration), administered subcutaneously every 12 hours to patients in a large clinical trial resulted in aPTT values of 45 seconds or less in the majority of patients (n = 1607).

A 30 mg intravenous bolus immediately followed by a 1 mg/kg subcutaneous administration resulted in aPTT post injection values of 50 seconds. The average aPTT prolongation value on Day 1 was about 16% higher than on Day 4.

12.3Pharmacokinetics Absorption Pharmacokinetic trials were conducted using the 100 mg/mL formulation. Maximum anti-Factor Xa and anti-thrombin (anti-Factor IIa) activities occur 3 to 5 hours after subcutaneous injection of enoxaparin. Mean peak anti-Factor Xa activity was

0.16IU/mL (1.58 mcg/mL) and

0.38IU/mL (3.83 mcg/mL) after the 20 mg and the 40 mg clinically tested subcutaneous doses, respectively. Mean (n = 46) peak anti-Factor Xa activity was

1.1IU/mL at steady state in patients with unstable angina receiving 1 mg/kg subcutaneously every 12 hours for 14 days. Mean absolute bioavailability of enoxaparin, after 1.5 mg/kg given subcutaneously, based on anti-Factor Xa activity is approximately 100% in healthy subjects. A 30 mg intravenous bolus immediately followed by 1 mg/kg subcutaneously every 12 hours provided initial peak anti-Factor Xa levels of

1.16IU/mL (n=16) and average exposure corresponding to 84% of steady-state levels. Steady state is achieved on the second day of treatment. Enoxaparin pharmacokinetics appears to be linear over the recommended dosage ranges [ see Dosage and Administration ( 2 ) ].

After repeated subcutaneous administration of 40 mg once daily and 1.5 mg/kg once-daily regimens in healthy volunteers, the steady-state is reached on day 2 with an average exposure ratio about 15% higher than after a single dose. Steady state enoxaparin activity levels are well predicted by single-dose pharmacokinetics. After repeated subcutaneous administration of the 1 mg/kg twice-daily regimen, the steady state is reached from day 4 with mean exposure about 65% higher than after a single dose and mean peak and trough levels of about 1.2 and

0.52IU/mL, respectively. Based on enoxaparin sodium pharmacokinetics, this difference in steady state is expected and within the therapeutic range. Although not studied clinically, the 150 mg/mL concentration of enoxaparin sodium is projected to result in anticoagulant activities similar to those of 100 mg/mL and 200 mg/mL concentrations at the same enoxaparin dose.

When a daily 1.5 mg/kg subcutaneous injection of enoxaparin sodium was given to 25 healthy male and female subjects using a 100 mg/mL or a 200 mg/mL concentration the following pharmacokinetic profiles were obtained [see Table 13 ]. Table 13 Pharmacokinetic Parameters* After 5 Days of 1.5 mg/kg Subcutaneously Once Daily Doses of Enoxaparin Sodium Using 100 mg/mL or 200 mg/mL Concentrations * Means ± SD at Day 5 and 90% Confidence Interval (CI) of the ratio † Median (range) Concentration Anti-Xa Anti-IIa Heptest aPTT A max (IU/mL or Δ sec) 100 mg/mL 1.37 (±0.23) 0.23 (±0.05) 105 (±17) 19 (±5) 200 mg/mL 1.45 (±0.22) 0.26 (±0.05) 111 (±17) 22 (±7) 90% CI 102–110% 102–111% t max † (h) 100 mg/mL 3 (2–6) 4 (2–5) 2.5 (2–4.5) 3 (2–4.5) 200 mg/mL 3.5 (2–6) 4.5 (2.5–6) 3.3 (2–5) 3 (2–5) AUC (ss) (h*IU/mL or h * Δ sec) 100 mg/mL 14.26 (±2.93) 1.54 (±0.61) 1321 (±219) 200 mg/mL 15.43 (±2.96) 1.77 (… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action Enoxaparin is a low molecular weight heparin which has antithrombotic properties.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Enoxaparin sodium injection, USP is available in two concentrations [see Tables 26 and 27 ]: Table 26 100 mg/mL Concentration * Strength represents the number of milligrams of enoxaparin sodium in Water for Injection. Enoxaparin sodium injection, USP 30 and 40 mg prefilled syringes, and 60, 80, and 100 mg graduated prefilled syringes each contain 10 mg enoxaparin sodium per 0.1 mL Water for Injection. †Approximate anti-Factor Xa activity based on reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard. ‡ Each enoxaparin sodium injection, USP prefilled syringe is for single, one-time use only and is affixed with a 27 gauge × 1/2 inch needle.

Dosage Unit / Strength * Anti-Xa Activity † Unit of Sale Syringe Label Color Each Prefilled Syringes ‡ 30 mg/0.3 mL 3000 IU NDC# 63323-559-65 10 syringes per carton Medium Blue NDC# 63323-559-63 40 mg/0.4 mL 4000 IU NDC# 63323-564-65 10 syringes per carton Yellow NDC# 63323-564-63 Graduated Prefilled Syringes ‡ 60 mg/0.6 mL 6000 IU NDC# 63323-566-65 10 syringes per carton Orange NDC# 63323-566-63 80 mg/0.8 mL 8000 IU NDC# 63323-584-65 10 syringes per carton Brown NDC# 63323-584-63 100 mg/mL 10,000 IU NDC# 63323-586-65 10 syringes per carton Black NDC# 63323-586-63 Table 27 150 mg/mL Concentration * Strength represents the number of milligrams of enoxaparin sodium in Water for Injection.

Enoxaparin sodium injection, USP 120 and 150 mg graduated prefilled syringes contain 15 mg enoxaparin sodium per 0.1 mL Water for Injection . † Approximate anti-Factor Xa activity based on reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard. ‡ Each enoxaparin sodium injection, USP graduated prefilled syringe is for single, one-time use only and is affixed with a 27 gauge × 1/2 inch needle. Dosage Unit / Strength * Anti-Xa Activity † Unit of Sale Syringe Label Color Each Graduated Prefilled Syringes ‡ 120 mg/0.8 mL 12,000 IU NDC# 63323-655-56 10 syringes per carton Purple NDC# 63323-655-31 150 mg/mL 15,000 IU NDC# 63323-589-54 10 syringes per carton Navy Blue NDC# 63323-589-31 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Store in the original carton or packaging until ready to use. Keep out of reach of children

📋 Description ~1 min read ▾

11 DESCRIPTION Enoxaparin sodium injection is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa.

Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains an 1,6 anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt.

The average molecular weight is about 4500 daltons. The molecular weight distribution is: <2000 daltons ≤20% 2000 to 8000 daltons ≥68% >8000 daltons ≤18% STRUCTURAL FORMULA * X = Percent of polysaccharide chain containing 1,6 anhydro derivative on the reducing end. R X * = 15 to 25% n= 0 to 20 100 - X H n =1 to 21 Enoxaparin sodium injection 100 mg/mL concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O.

First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin sodium injection 150 mg/mL concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection.

The enoxaparin sodium injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection [ see Dosage and Administration ( 2 ) and How Supplied/Storage and Handling ( 16 ) ]. enoxa-struc-01.jpg enoxa-struc-02.jpg

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs, platelet inhibitors, or other anticoagulants, advise them to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness (especially in the lower limbs) and muscular weakness. Instruct the patient to seek immediate medical attention if any of these symptoms occur.

Inform patients: • of the instructions for injecting enoxaparin sodium injection if they continue enoxaparin sodium injection therapy after discharge from the hospital. • that it may take them longer than usual to stop bleeding. • that they may bruise and/or bleed more easily when they use enoxaparin sodium injection. • that they should report any unusual bleeding, bruising, or signs of thrombocytopenia (such as a rash of dark red spots under the skin) to their physician [ see Warnings and Precautions ( 5.1 , 5.5 ) ]. • to tell their physicians and dentists they are taking enoxaparin sodium injection and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken [ see Warnings and Precautions ( 5.1 , 5.3 ) ]. • to tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAIDs [ see Drug Interactions ( 7 ) ].

Novaplus is a registered trademark of Vizient, Inc. Manufactured for: Fresenius Kabi Lake Zurich, IL 60047 www.fresenius-kabi.com/us Made in India enoxa-img-08.jpg

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Pharmacokinetic trials were conducted using the 100 mg/mL formulation. Maximum anti-Factor Xa and anti-thrombin (anti-Factor IIa) activities occur 3 to 5 hours after subcutaneous injection of enoxaparin. Mean peak anti-Factor Xa activity was

0.16IU/mL (1.58 mcg/mL) and

0.38IU/mL (3.83 mcg/mL) after the 20 mg and the 40 mg clinically tested subcutaneous doses, respectively. Mean (n = 46) peak anti-Factor Xa activity was

1.1IU/mL at steady state in patients with unstable angina receiving 1 mg/kg subcutaneously every 12 hours for 14 days. Mean absolute bioavailability of enoxaparin, after 1.5 mg/kg given subcutaneously, based on anti-Factor Xa activity is approximately 100% in healthy subjects. A 30 mg intravenous bolus immediately followed by 1 mg/kg subcutaneously every 12 hours provided initial peak anti-Factor Xa levels of

1.16IU/mL (n=16) and average exposure corresponding to 84% of steady-state levels. Steady state is achieved on the second day of treatment. Enoxaparin pharmacokinetics appears to be linear over the recommended dosage ranges [ see Dosage and Administration ( 2 ) ].

After repeated subcutaneous administration of 40 mg once daily and 1.5 mg/kg once-daily regimens in healthy volunteers, the steady-state is reached on day 2 with an average exposure ratio about 15% higher than after a single dose. Steady state enoxaparin activity levels are well predicted by single-dose pharmacokinetics. After repeated subcutaneous administration of the 1 mg/kg twice-daily regimen, the steady state is reached from day 4 with mean exposure about 65% higher than after a single dose and mean peak and trough levels of about 1.2 and

0.52IU/mL, respectively. Based on enoxaparin sodium pharmacokinetics, this difference in steady state is expected and within the therapeutic range. Although not studied clinically, the 150 mg/mL concentration of enoxaparin sodium is projected to result in anticoagulant activities similar to those of 100 mg/mL and 200 mg/mL concentrations at the same enoxaparin dose.

When a daily 1.5 mg/kg subcutaneous injection of enoxaparin sodium was given to 25 healthy male and female subjects using a 100 mg/mL or a 200 mg/mL concentration the following pharmacokinetic profiles were obtained [see Table 13 ]. Table 13 Pharmacokinetic Parameters* After 5 Days of 1.5 mg/kg Subcutaneously Once Daily Doses of Enoxaparin Sodium Using 100 mg/mL or 200 mg/mL Concentrations * Means ± SD at Day 5 and 90% Confidence Interval (CI) of the ratio † Median (range) Concentration Anti-Xa Anti-IIa Heptest aPTT A max (IU/mL or Δ sec) 100 mg/mL 1.37 (±0.23) 0.23 (±0.05) 105 (±17) 19 (±5) 200 mg/mL 1.45 (±0.22) 0.26 (±0.05) 111 (±17) 22 (±7) 90% CI 102–110% 102–111% t max † (h) 100 mg/mL 3 (2–6) 4 (2–5) 2.5 (2–4.5) 3 (2–4.5) 200 mg/mL 3.5 (2–6) 4.5 (2.5–6) 3.3 (2–5) 3 (2–5) AUC (ss) (h*IU/mL or h * Δ sec) 100 mg/mL 14.26 (±2.93) 1.54 (±0.61) 1321 (±219) 200 mg/mL 15.43 (±2.96) 1.77 (±0.67) 1401 (±227) 90% CI 105–112% 103–109% Distribution The volume of distribution of anti-Factor Xa activity is about

4.3L. Elimination Following intravenous dosing, the total body clearance of enoxaparin is 26 mL/min. After intravenous dosing of enoxaparin labeled with the gamma-emitter, 99m Tc, 40% of radioactivity and 8 to 20% of anti-Factor Xa activity were recovered in urine in 24 hours.

Elimination half-life based on anti-Factor Xa activity was 4.5 hours after a single subcutaneous dose to about 7 hours after repeated dosing. Significant anti-Factor Xa activity persists in plasma for about 12 hours following a 40 mg subcutaneous once a day dose. Following subcutaneous dosing, the apparent clearance (CL/F) of enoxaparin is approximately 15 mL/min.

Metabolism Enoxaparin sodium is primarily metabolized in the liver by desulfation and/or depolymerization to lower molecular weight species with much reduced biological potency. Renal clearance of active fragments represents about 10% of the administered dose and total renal… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 153 words ▾

12.2Pharmacodynamics In humans, enoxaparin given at a dose of 1.5 mg/kg subcutaneously is characterized by a higher ratio of anti-Factor Xa to anti-Factor IIa activity (mean ± SD, 14.0 ± 3.1) (based on areas under anti-Factor activity versus time curves) compared to the ratios observed for heparin (mean ± SD, 1.22 ± 0.13). Increases of up to 1.8 times the control values were seen in the thrombin time (TT) and the activated partial thromboplastin time (aPTT). Enoxaparin at a 1 mg/kg dose (100 mg/mL concentration), administered subcutaneously every 12 hours to patients in a large clinical trial resulted in aPTT values of 45 seconds or less in the majority of patients (n = 1607).

A 30 mg intravenous bolus immediately followed by a 1 mg/kg subcutaneous administration resulted in aPTT post injection values of 50 seconds. The average aPTT prolongation value on Day 1 was about 16% higher than on Day 4.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Prophylaxis of Deep Vein Thrombosis following Abdominal Surgery in Patients at Risk for Thromboembolic Complications Abdominal surgery patients at risk include those who are over 40 years of age, obese, undergoing surgery under general anesthesia lasting longer than 30 minutes or who have additional risk factors such as malignancy or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE). In a double-blind, parallel group study of patients undergoing elective cancer surgery of the gastrointestinal, urological, or gynecological tract, a total of 1116 patients were enrolled in the study, and 1115 patients were treated.

Patients ranged in age from 32 to 97 years (mean age 67 years) with 52.7% men and 47.3% women. Patients were 98% Caucasian, 1.1% Black, 0.4% Asian and 0.4% others. Enoxaparin sodium injection 40 mg subcutaneously, administered once a day, beginning 2 hours prior to surgery and continuing for a maximum of 12 days after surgery, was comparable to heparin 5000 U every 8 hours subcutaneously in reducing the risk of DVT.

The efficacy data are provided below [see Table 14 ]. Table 14 Efficacy of Enoxaparin Sodium Injection in the Prophylaxis of Deep Vein Thrombosis following Abdominal Surgery * VTE = Venous thromboembolic events which included DVT, PE, and death considered to be thromboembolic in origin. † CI = Confidence Interval. Indication Dosing Regimen Enoxaparin Sodium Injection 40 mg daily subcutaneously n (%) Heparin 5000 U q8h subcutaneously n (%) All Treated Abdominal Surgery Patients 555 (100) 560 (100) Treatment Failures Total VTE * (%) 56 (10.1) (95% CI † : 8 to 13) 63 (11.3) (95% CI: 9 to 14) DVT Only (%) 54 (9.7) (95% CI: 7 to 12) 61 (10.9) (95% CI: 8 to 13) In a second double-blind, parallel group study, enoxaparin sodium injection 40 mg subcutaneously once a day was compared to heparin 5000 U every 8 hours subcutaneously in patients undergoing colorectal surgery (one-third with cancer).

A total of 1347 patients were randomized in the study and all patients were treated. Patients ranged in age from 18 to 92 years (mean age 50.1 years) with 54.2% men and 45.8% women. Treatment was initiated approximately 2 hours prior to surgery and continued for approximately 7 to 10 days after surgery.

The efficacy data are provided below [see Table 15 ]. Table 15 Efficacy of Enoxaparin Sodium Injection in the Prophylaxis of Deep Vein Thrombosis following Colorectal Surgery * VTE = Venous thromboembolic events which included DVT, PE, and death considered to be thromboembolic in origin. † CI = Confidence Interval Indication Dosing Regimen Enoxaparin Sodium Injection 40 mg daily subcutaneously n (%) Heparin 5000 U q8h subcutaneously n (%) All Treated Colorectal Surgery Patients 673 (100) 674 (100) Treatment Failures Total VTE * (%) 48 (7.1) (95% CI † : 5 to 9) 45 (6.7) (95% CI: 5 to 9) DVT Only (%) 47 (7.0) (95% CI: 5 to 9) 44 (6.5) (95% CI: 5 to 8)

14.2Prophylaxis of Deep Vein Thrombosis following Hip or Knee Replacement Surgery Enoxaparin sodium injection has been shown to reduce the risk of post-operative deep vein thrombosis (DVT) following hip or knee replacement surgery. In a double-blind study, enoxaparin sodium injection 30 mg every 12 hours subcutaneously was compared to placebo in patients with hip replacement. A total of 100 patients were randomized in the study and all patients were treated.

Patients ranged in age from 41 to 84 years (mean age 67.1 years) with 45% men and 55% women. After hemostasis was established, treatment was initiated 12 to 24 hours after surgery and was continued for 10 to 14 days after surgery. The efficacy data are provided below [see Table 16 ].

Table 16 Efficacy of Enoxaparin Sodium Injection in the Prophylaxis of Deep Vein Thrombosis following Hip Replacement Surgery * p value versus placebo = 0.0002 † p value versus placebo = 0.0134 Indication Dosing Regimen Enoxaparin Sodium Injection 30 mg q12h subcutaneously n (%) Placebo q12h subcutaneously… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 205 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies in animals have been performed to evaluate the carcinogenic potential of enoxaparin. Enoxaparin was not mutagenic in in vitro tests, including the Ames test, mouse lymphoma cell forward mutation test, and human lymphocyte chromosomal aberration test, and the in vivo rat bone marrow chromosomal aberration test. Enoxaparin was found to have no effect on fertility or reproductive performance of male and female rats at subcutaneous doses up to 20 mg/kg/day or 141 mg/m 2 /day.

The maximum human dose in clinical trials was 2.0 mg/kg/day or 78 mg/m 2 /day (for an average body weight of 70 kg, height of 170 cm, and body surface area of 1.8 m 2 ).

13.2Animal Toxicology and/or Pharmacology A single subcutaneous dose of 46.4 mg/kg enoxaparin was lethal to rats. The symptoms of acute toxicity were ataxia, decreased motility, dyspnea, cyanosis, and coma.

13.3Reproductive and Developmental Toxicology Teratology studies have been conducted in pregnant rats and rabbits at subcutaneous doses of enoxaparin up to 30 mg/kg/day corresponding to 211 mg/m 2 /day and 410 mg/m 2 /day in rats and rabbits respectively. There was no evidence of teratogenic effects or fetotoxicity due to enoxaparin.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 120 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies in animals have been performed to evaluate the carcinogenic potential of enoxaparin. Enoxaparin was not mutagenic in in vitro tests, including the Ames test, mouse lymphoma cell forward mutation test, and human lymphocyte chromosomal aberration test, and the in vivo rat bone marrow chromosomal aberration test. Enoxaparin was found to have no effect on fertility or reproductive performance of male and female rats at subcutaneous doses up to 20 mg/kg/day or 141 mg/m 2 /day.

The maximum human dose in clinical trials was 2.0 mg/kg/day or 78 mg/m 2 /day (for an average body weight of 70 kg, height of 170 cm, and body surface area of 1.8 m 2 ).

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE Enoxaparin Sodium Injection for subcutaneous use Single-dose prefilled syringe This Instructions for Use contains information on how to prepare and inject enoxaparin sodium injection prefilled syringe. Read this Instructions for Use before using the enoxaparin sodium injection prefilled syringe and each time you get a new prescription. There may be new information.

Do not inject yourself or someone else until you have been shown how to inject enoxaparin sodium injection. Your healthcare provider can show you or your caregiver how to prepare and inject a dose of enoxaparin sodium injection. Call your healthcare provider if you have any questions.

Important information: • Your healthcare provider will tell you the prescribed dose that you should take and how often you will need to inject enoxaparin sodium injection. If your dose is based on your body weight, your dose of enoxaparin sodium might be less than what is in the prefilled syringe. • Do not get rid of any air bubble(s) in the enoxaparin sodium injection prefilled syringe. This can lead to a loss of the medicine. • Enoxaparin sodium injection is injected as a subcutaneous (under the skin) injection only.

Do not inject enoxaparin sodium injection into muscle. • To avoid bruising, do not rub the injection site after you have injected yourself. • Do not use the enoxaparin sodium injection prefilled syringe if the needle cap is missing or not securely attached. • To protect from needle-stick injuries, each prefilled syringe has a safety system that covers the needle after injection. • Do not remove the needle cap until just before you give the injection. • Throw away (dispose of) the used enoxaparin sodium injection prefilled syringe and needle cap right away after use, even if there is medicine left in the prefilled syringe.

See “ Step 13: Dispose of used enoxaparin sodium injection prefilled syringes and needle caps ” below. • Do not touch the syringe plunger rod until you are ready to inject. Do not pull back on the plunger rod at any time. • Enoxaparin sodium injection is for one time use only. Do not reuse an enoxaparin sodium injection prefilled syringe.

Storing enoxaparin sodium injection prefilled syringes: • Store enoxaparin sodium injection prefilled syringes at 77°F (25°C). • Store enoxaparin sodium injection prefilled syringes in the original carton or packaging until ready to use. • Keep enoxaparin sodium injection prefilled syringes and all medicines out of the reach of children. Parts of enoxaparin sodium injection prefilled syringe: Preparing to inject enoxaparin sodium injection prefilled syringe: Step 1: Gather the following supplies for your injection (see Figure A) : • 1 enoxaparin sodium injection prefilled syringe • 1 alcohol wipe * • 1 cotton ball or gauze * • a small adhesive bandage, if needed * • a sharps disposal container * (see Step 13) * Items not included.

Step 2: Wash your hands well with soap and water. Step 3: Preparing a dose of enoxaparin sodium injection Take the prefilled syringe out of the package. Open the packaging by peeling the lid at the arrow as directed.

Take the prefilled syringe out of the plastic container by holding the middle of the syringe body (see Figure B). • Do not remove the prefilled syringe by pulling on the plunger rod or the needle cap as this may damage the syringe. • Do not pull off the needle cap until you are ready to inject. • Do not use the enoxaparin sodium injection prefilled syringe if it has been dropped on a hard surface or damaged. Step 4: Check the enoxaparin sodium injection prefilled syringe When you receive your enoxaparin sodium injection syringes, always check to see that: • you have the correct medicine and dose. • the expiration date on the prefilled syringe has not passed (see Figure C). • Do not use the enoxaparin sodium injection prefilled syringe if the expiration date has passed.

Step 5: Check the medicine • Look at the medicine inside the enoxaparin sodium injection pr… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~2 min read ▾

Principal Display Panel – 30 mg per 0.3 mL Syringe – Shelf Carton NP551993 NDC 63323- 559 -65 Rx only Enoxaparin Sodium Injection, USP 30 mg per 0.3 mL SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Sterile 10 x 0.3 mL Syringes enoxa-label-01.jpg

Principal Display Panel - 30 mg per 0.3 mL Syringe – Blister NDC 63323- 559 -63 Rx only Enoxaparin Sodium Injection, USP 30 mg per 0.3 mL Single Dose Syringe with Automatic Safety Device For Subcutaneous Injection One 0.3 mL Syringe enoxa-label-02.jpg

Principal Display Panel – 40 mg per 0.4 mL Syringe – Shelf Carton NP556497 NDC 63323- 564 -65 Rx only Enoxaparin Sodium Injection, USP 40 mg per 0.4 mL SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Sterile 10 x 0.4 mL Syringes enoxa-label-03.jpg

Principal Display Panel - 40 mg per 0.4 mL Syringe – Blister NDC 63323- 564 -63 Rx only Enoxaparin Sodium Injection, USP 40 mg per 0.4 mL Single Dose Syringe with Automatic Safety Device For Subcutaneous Injection One 0.4 mL Syringe enoxa-label-04.jpg

Principal Display Panel – 60 mg per 0.6 mL Syringe – Shelf Carton NDC 63323-566-65 NP556698 Enoxaparin Sodium Injection, USP 60 mg per 0.6 mL Rx ONLY Single-Dose Syringes with Automatic Safety Device For Subcutaneous Injection Sterile Contains 10 x 0.6 mL Single-Dose Syringes enoxa-label-05.jpg

Principal Display Panel - 60 mg per 0.6 mL Syringe – Blister NDC 63323-566-63 Enoxaparin Sodium Injection, USP 60 mg per 0.6 mL One 0.6 mL Sterile Single-Dose Syringe with Automatic Safety Device For Subcutaneous Injection Rx only enoxa-label-06.jpg

Principal Display Panel - 80 mg per 0.8 mL Syringe – Shelf Carton NDC 63323-584-65 NP558499 Enoxaparin Sodium Injection, USP 80 mg per 0.8 mL Rx ONLY Single-Dose Syringes with Automatic Safety Device For Subcutaneous Injection Sterile Contains 10 x 0.8 mL Single-Dose Syringes enoxa-label-07.jpg

Principal Display Panel - 80 mg per 0.8 mL Syringe – Blister NDC 63323-584-63 Enoxaparin Sodium Injection, USP 80 mg per 0.8 mL One 0.8 mL Sterile Single-Dose Syringe with Automatic Safety Device For Subcutaneous Injection Rx only enoxa-label-08.jpg

Principal Display Panel - 100 mg per mL Syringe – Shelf Carton NDC 63323-586-65 NP558696 Enoxaparin Sodium Injection, USP 100 mg per mL Rx ONLY Single-Dose Syringes with Automatic Safety Device For Subcutaneous Injection Sterile Contains 10 x 1 mL Single-Dose Syringes enoxa-label-09.jpg

Principal Display Panel - 100 mg per mL Syringe – Blister NDC 63323-586-63 Enoxaparin Sodium Injection, USP 100 mg per mL One 1 mL Sterile Single-Dose Syringe with Automatic Safety Device For Subcutaneous Injection Rx only enoxa-label-10.jpg

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
258
Units reimbursed last 4 qtrs
4.4K
Gross reimbursed last 4 qtrs
$33.5K
Avg / prescription
$129.68
Avg / unit
$7.5578
Latest quarter Q1 2026
40Rx
Medicaid pays / mL
$7.5578
gross reimbursed
vs
NADAC / mL
$6.4517
acquisition cost
=
Spread
+$1.1061
+17% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
19% FFS 81% MCO
Fee-for-service · 49 Rx Managed care · 209 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 1,607 units · 27.2 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 2,085 units · 17.7 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 234 units · 0.6 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 70 units · 1.5 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 431 units · 5.8 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.627.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Wisconsin 27.2 /100k
2 Ohio 17.7 /100k
3 Arizona 5.8 /100k
4 Kentucky 1.5 /100k
5 California 0.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 syringe this page63323-0586-96 258 Rx · $33,458
1 syringe63323-0586-65 No Medicaid data
Drug total (last 4 qtrs): 258 Rx · 4,427 units · $33,458 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Enoxaparin Sodium — the program that covers self-administered drugs. 13 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 Enoxaparin 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
$20.1M
Claims incl. refills
131.2K
Beneficiaries
84K
Spend / beneficiary
$239.28
Spend / claim
$153.24
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.
← 63323-0584-65 · Fresenius 63323-0589-94 · Fresenius →
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.