Quick answers
- What is Bivalirudin used for?
- The FDA-approved label (Bivalirudin, Civica, Inc., September 10, 2025) says: “Bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bivalirudin have a boxed warning?
- No. None of the 15 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Bivalirudin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bivalirudin been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started July 3, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Bivalirudin?
- 13 companies list prescription products of Bivalirudin in the FDA NDC Directory, including Meitheal Pharmaceuticals Inc., Fresenius Kabi USA, LLC and Dr. Reddy's Laboratories Limited.
What Bivalirudin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. …
— FDA label: Bivalirudin, Civica, Inc., effective September 10, 2025. Read the full label on DailyMed →
The FDA has 15 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.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Injection, solution · Injection · Injection, powder, lyophilized, for suspension |
|---|---|
| Route | Intravenous · Intracavernous |
| Prescription products | 13 in the FDA NDC Directory |
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.
- Meitheal Pharmaceuticals Inc.2 products
- Fresenius Kabi USA, LLC2 products
- Dr. Reddy's Laboratories Limited1 product
- Avenacy, LLC1 product
- Sandoz Inc1 product
- Mylan Institutional LLC1 product
- Hainan Shuangcheng Pharmaceuticals Co., Ltd.1 product
- Eugia US LLC1 product
- Accord Healthcare Inc.1 product
- Slate Run Pharmaceuticals, LLC1 product
- MAIA Pharmaceuticals, Inc.1 product
- Civica, Inc.1 product
- Par Health USA, LLC1 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 |
|---|---|---|---|
| NDA020873 ANGIOMAX | Sandoz | December 15, 2000 | 22, latest July 2, 2019 2019: Labeling · 2018: Labeling · 2016: Manufacturing (CMC) |
| NDA211215 ANGIOMAX RTU | Maia Pharms Inc | July 25, 2019 | 1, latest May 9, 2023 2023: Labeling |
Generic approvals (8)
- ANDA090189Fresenius Kabi USA · October 28, 2016
- ANDA201577DR Reddys · May 26, 2017
- ANDA206551Accord Hlthcare · November 22, 2017
- ANDA202471Mylan Institutional · June 1, 2018
- ANDA091602Meitheal · July 16, 2018
- ANDA205962Eugia Pharma · July 27, 2018
- ANDA210031Shuangcheng · October 23, 2019
- ANDA213078Hainan Poly · May 28, 2021
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.
-
July 3, 2023 · Class II · Terminated · D-0918-2023
Presence of Particulate Matter: Particulate matter identified as fiber.
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67. — Accord Healthcare, 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
| RxCUI (RxNorm) | 308769, 1997015 |
|---|---|
| SPL set ID of the quoted label | 19a4afc5-151d-4d3c-bfef-48aa8797d695 |
| FDA labels (SPL) | 15 |
| FDA applications | NDA020873, NDA211215, 8 ANDA |
| Active ingredients (FDA) | BIVALIRUDIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Bivalirudin, Civica, Inc., effective September 10, 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 →