Quick answers
- What is Enoxaparin sodium used for?
- The FDA-approved label (Lovenox, Sanofi-Aventis U.S. LLC, May 28, 2026) says: “Lovenox 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 Inpatient treatment of acute DVT with or without pulmonary embolism Outpatient treatment of acute DVT without pulmonary embolism Prophylaxis of ischemic …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Enoxaparin sodium have a boxed warning?
- Yes. The FDA label for Lovenox has a boxed warning (“WARNING: SPINAL/EPIDURAL HEMATOMAS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Enoxaparin sodium?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated October 20, 2026). Ask your pharmacist about alternatives.
- Has Enoxaparin sodium been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started August 5, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Enoxaparin sodium?
- 17 companies list prescription products of Enoxaparin sodium in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Sanofi-Aventis U.S. LLC and Meitheal Pharmaceuticals Inc..
What Enoxaparin sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Lovenox 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 Inpatient treatment of acute DVT with or without pulmonary embolism Outpatient treatment of acute DVT without pulmonary embolism Prophylaxis of ischemic …
— FDA label: Lovenox, Sanofi-Aventis U.S. LLC, effective May 28, 2026. Read the full label on DailyMed →
The FDA has 23 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SPINAL/EPIDURAL HEMATOMAS
. Read it on the full label →
22 of 23 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Subcutaneous · Intravenous |
| Prescription products | 146 in the FDA NDC Directory |
| Brand names | Lovenox |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| enoxaparin sodium 100 mg/mL injection | Generic | $6.78–$8.54 per mL 41 packages, lowest to highest |
| enoxaparin sodium 100 mg/mL injection, solution | Generic | $6.78 per mL |
| enoxaparin sodium 120 mg/0.8 mL injection | Generic | $10.57 per mL |
| enoxaparin sodium 120 mg/0.8 mL injection, solution | Generic | $10.57 per mL |
| enoxaparin sodium 150 mg/mL injection | Generic | $9.08–$10.57 per mL 17 packages, lowest to highest |
| enoxaparin sodium 150 mg/mL injection, solution | Generic | $9.08 per mL |
| enoxaparin sodium 30 mg/0.3 mL injection | Generic | $8.54 per mL |
| enoxaparin sodium 30 mg/0.3 mL injection, solution | Generic | $8.54 per mL |
| enoxaparin sodium 300 mg/3 mL injection | Generic | $9.98 per mL |
| enoxaparin sodium 40 mg/0.4 mL injection | Generic | $7.47 per mL |
| enoxaparin sodium 40 mg/0.4 mL injection | Brand: Lovenox | $6.78 per mL |
| enoxaparin sodium 40 mg/0.4 mL injection, solution | Generic | $7.47 per mL |
| enoxaparin sodium 60 mg/0.6 mL injection | Generic | $7.31 per mL |
| enoxaparin sodium 60 mg/0.6 mL injection, solution | Generic | $7.31 per mL |
| enoxaparin sodium 80 mg/0.8 mL injection | Generic | $7.00 per mL |
| enoxaparin sodium 80 mg/0.8 mL injection, solution | Generic | $7.00 per mL |
NADAC list of November 4, 2026; these prices took effect between November 19, 2025 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Fresenius Kabi USA, LLC28 products
- Sanofi-Aventis U.S. LLC24 products
- Meitheal Pharmaceuticals Inc.16 products
- Sandoz Inc14 products
- BluePoint Laboratories11 products
- Amphastar Pharmaceuticals, Inc.8 products
- BE Pharmaceuticals Inc.7 products
- Italfarmaco SpA7 products
- NorthStar Rx LLC7 products
- Gland Pharma Limited7 products
- NorthStar RxLLC7 products
- Hepalink USA Inc.7 products
- Hebei Changshan Biochemical Pharmaceutical Co., Ltd.7 products
- Zydus Pharmaceuticals USA Inc.7 products
- Cardinal Health 107, LLC7 products
- Sagent Pharmaceuticals2 products
- Civica, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020164 LOVENOX, LOVENOX (PRESERVATIVE FREE) | Sanofi Aventis Us | March 29, 1993 | 73, latest July 28, 2023 2023: Labeling · 2022: Labeling · 2021: Labeling |
Generic approvals (10)
- ANDA077857Sandoz · July 23, 2010
- ANDA076684Amphastar Pharm · September 19, 2011
- ANDA076726Zydus Pharms · June 23, 2014
- ANDA078990Gland · September 28, 2018
- ANDA208600Amphastar Pharms Inc · March 14, 2019
- ANDA206834Emerge Bioscience · November 29, 2019
- ANDA214856Emerge Bioscience · June 14, 2022
- ANDA205660Shenzhen Techdow · March 15, 2023
- ANDA214646Be Pharms · June 6, 2023
- ANDA218775Hebei Changshan · January 7, 2026
Shortage status
To be discontinued · updated October 20, 2026 · first posted October 20, 2026
| Product | Lovenox, Injection, 150 mg/1 mL (NDC 0075-2915-01) |
|---|---|
| Company | Sanofi-Aventis U.S. LLC |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 5, 2025 · Class II · Ongoing · D-0597-2025
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer package - NDC 55154-3543- — Cardinal Health Inc.
-
January 26, 2022 · Class II · Terminated · D-0179-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69 — CARDINAL HEALTHCARE
-
December 5, 2017 · Class III · Terminated · D-0153-2018
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10 — Sanofi-Aventis U.S. LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lovenox, Sanofi-Aventis U.S. LLC, effective May 28, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →