Quick answers
- What is Warfarin sodium used for?
- The FDA-approved label (Jantoven, Upsher-Smith Laboratories, LLC, July 8, 2025) says: “JANTOVEN ® is indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Warfarin sodium have a boxed warning?
- Yes. The FDA label for Jantoven has a boxed warning (“WARNING: BLEEDING RISK”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Warfarin sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Warfarin sodium been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started January 26, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Warfarin sodium?
- 18 companies list prescription products of Warfarin sodium in the FDA NDC Directory, including Remedyrepack Inc., Aphena Pharma Solutions - Tennessee, LLC and Golden State Medical Supply, Inc..
What Warfarin sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
JANTOVEN ® is indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. …
— FDA label: Jantoven, Upsher-Smith Laboratories, LLC, effective July 8, 2025. Read the full label on DailyMed →
The FDA has 71 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: BLEEDING RISK
. Read it on the full label →
71 of 71 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 149 in the FDA NDC Directory |
| Brand names | Jantoven |
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 |
|---|---|---|
| warfarin sodium 1 mg tablet | Generic | $0.1024 per tablet |
| warfarin sodium 10 mg tablet | Generic | $0.1091 per tablet |
| warfarin sodium 2 mg tablet | Generic | $0.0953 per tablet |
| warfarin sodium 2.5 mg tablet | Generic | $0.0965 per tablet |
| warfarin sodium 3 mg tablet | Generic | $0.1008 per tablet |
| warfarin sodium 4 mg tablet | Generic | $0.1005 per tablet |
| warfarin sodium 5 mg tablet | Generic | $0.0892 per tablet |
| warfarin sodium 6 mg tablet | Generic | $0.0952 per tablet |
| warfarin sodium 7.5 mg tablet | Generic | $0.0878 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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.
- Remedyrepack Inc.24 products
- Aphena Pharma Solutions - Tennessee, LLC15 products
- Golden State Medical Supply, Inc.15 products
- Bryant Ranch Prepack14 products
- A-S Medication Solutions14 products
- Teva Pharmaceuticals USA, Inc.9 products
- Sun Pharmaceutical Industries, Inc.9 products
- Amneal Pharmaceuticals LLC9 products
- Exelan Pharmaceuticals Inc.9 products
- Upsher-Smith Laboratories, LLC9 products
- Coupler LLC6 products
- Northwind Health Company, LLC3 products
- Cardinal Health 107, LLC3 products
- American Health Packaging3 products
- Proficient Rx LP3 products
- Direct_Rx2 products
- Preferred Pharmaceuticals Inc.1 product
- PD-Rx Pharmaceuticals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA040301Taro · July 15, 1999
- ANDA040416Upsher Smith Labs · October 2, 2003
- ANDA040616Pliva · July 5, 2006
- ANDA090935Invagen Pharms · May 25, 2011
- ANDA202202Amneal Pharms · March 4, 2013
Shortage status
The FDA drug shortage list does not show these products.
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.
-
January 26, 2022 · Class II · Terminated · D-0200-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01 — CARDINAL HEALTHCARE
-
January 26, 2022 · Class II · Terminated · D-0201-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01 — CARDINAL HEALTHCARE
-
August 25, 2014 · Class III · Terminated · D-1584-2014
Failed Content Uniformity Specifications.
Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110. Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 105 — Taro Pharmaceuticals U.S.A., Inc.
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) — Jantoven, Upsher-Smith Laboratories, LLC, effective July 8, 2025; 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 →