Quick answers
- What is Paclitaxel used for?
- The FDA-approved label (Abraxane, Abraxis BioScience, LLC, October 31, 2022) says: “ABRAXANE is a microtubule inhibitor indicated for the treatment of: • Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Paclitaxel have a boxed warning?
- Yes. The FDA label for Abraxane has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Paclitaxel?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Paclitaxel been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started November 8, 2013 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Paclitaxel?
- 22 companies list prescription products of Paclitaxel in the FDA NDC Directory, including Teva Parenteral Medicines, Inc., Alembic Pharmaceuticals Limited and Alembic Pharmaceuticals Inc..
What Paclitaxel is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ABRAXANE is a microtubule inhibitor indicated for the treatment of: • Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. …
— FDA label: Abraxane, Abraxis BioScience, LLC, effective October 31, 2022. Read the full label on DailyMed →
The FDA has 25 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. Read it on the full label →
25 of 25 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection, powder, lyophilized, for suspension · Injection · Injection, solution, concentrate |
|---|---|
| Route | Intravenous |
| Prescription products | 41 in the FDA NDC Directory |
| Brand names | Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), Paclitaxel 100mg Per Vial, Abraxane, Paclitaxel Protein Bound Particles Albumin Bound |
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.
- Teva Parenteral Medicines, Inc.7 products
- Alembic Pharmaceuticals Limited3 products
- Alembic Pharmaceuticals Inc.3 products
- Novadoz Pharmaceuticals LLC3 products
- Natco Pharma USA LLC3 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.3 products
- BluePoint Laboratories3 products
- Gland Pharma Limited3 products
- NorthStar Rx LLC2 products
- Hospira, Inc.2 products
- Fresenius Kabi USA, LLC1 product
- Meitheal Pharmaceuticals Inc.1 product
- Bryant Ranch Prepack1 product
- Exelan Pharmaceuticals Inc.1 product
- Sagent Pharmaceuticals1 product
- Abraxis BioScience, LLC1 product
- American Regent, Inc.1 product
- Cipla USA Inc.1 product
- Teva Pharmaceuticals, Inc.1 product
- Mylan Institutional LLC1 product
- Ningbo Shuangcheng Pharmaceutical Co., Ltd.1 product
- Sandoz Inc1 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 |
|---|---|---|---|
| NDA021660 ABRAXANE | Bristol-Myers | January 7, 2005 | 21, latest August 25, 2020 2020: Labeling · 2019: Efficacy · 2018: Labeling |
| NDA211875 PACLITAXEL | Am Regent | July 27, 2022 | — |
| NDA216338 PACLITAXEL | Teva Pharms Inc | May 11, 2023 | 1, latest November 21, 2023 2023: Efficacy |
Generic approvals (11)
- ANDA075184Teva Pharms · January 25, 2002
- ANDA076131Hospira · May 8, 2002
- ANDA077574Fresenius Kabi USA · November 27, 2006
- ANDA091540Natco Pharma USA · September 29, 2011
- ANDA207326Gland · August 23, 2016
- ANDA213434Msn · August 24, 2020
- ANDA216874Alembic · October 20, 2022
- ANDA212700Hengrui Pharma · October 8, 2024
- ANDA209657Cipla · April 10, 2025
- ANDA216355Shuangcheng · May 15, 2025
- ANDA217877Mylan · August 19, 2025
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.
-
November 8, 2013 · Class III · Terminated · D-016-2014
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India — Fresenius Kabi USA, LLC
-
June 27, 2012 · Class II · Terminated · D-1682-2012
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the parti
Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; N DC 61703-342-50 — Hospira 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) | 312199, 583214, 583218 |
|---|---|
| SPL set ID of the quoted label | 24d10449-2936-4cd3-b7db-a7683db721e4 |
| FDA labels (SPL) | 25 |
| FDA applications | NDA021660, NDA211875, NDA216338, 11 ANDA |
| Active ingredients (FDA) | PACLITAXEL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Abraxane, Abraxis BioScience, LLC, effective October 31, 2022; 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 →