Data / Drug companies / Alkylating Drug
Alkylating Drug drugs: 19 drugs from 47 companies in the FDA NDC directory
Alkylating Drug is an FDA established pharmacologic class. The FDA National Drug Code Directory lists 187 products in this class from 47 companies, covering 19 drugs by generic name. The main marketing category is generic drugs (ANDA), and the newest product started marketing on October 31, 2026.
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- 47Companies
- 187Products
- 19Drugs by generic name
Drugs in the Alkylating Drug class
Ranked by number of companies that list the drug.
| Drug | Products here | Companies listing it |
|---|---|---|
| Mitomycin | 33 | 14 |
| Carmustine | 1 | 13 |
| Temozolomide | 73 | 12 |
| Bendamustine hydrochloride | 15 | 10 |
| Thiotepa | 17 | 8 |
| Busulfan | 9 | 8 |
| Ifosfamide | 11 | 5 |
| Lomustine | 12 | 4 |
| Dacarbazine | 4 | 3 |
| Trabectedin | 2 | 2 |
| Bendamustine hcl | 2 | 1 |
| Chlorambucil | 1 | 1 |
| Ifosfamide for injection | 1 | 1 |
| Lurbinectedin | 1 | 1 |
| Mechlorethamine hydrochloride | 1 | 1 |
| Melphalan | 1 | 1 |
| Melphalan hcl | 1 | 1 |
| Procarbazine hydrochloride | 1 | 1 |
| Streptozocin | 1 | 1 |
Companies with the most products in this class
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Accord Healthcare Inc. | 12 | capsule; injection, powder, lyophilized, for solution | Generic drugs (ANDA) | December 7, 2022 |
| Meitheal Pharmaceuticals Inc. | 12 | injection, powder, lyophilized, for solution; injection, solution | Generic drugs (ANDA) | April 22, 2024 |
| Hikma Pharmaceuticals USA Inc. | 10 | injection, powder, lyophilized, for solution; injection | Generic drugs (ANDA) | September 29, 2023 |
| Bryant Ranch Prepack | 7 | capsule; injection, powder, lyophilized, for solution | Generic drugs (ANDA) | March 11, 2022 |
| Merck Sharp & Dohme LLC | 7 | capsule; injection, powder, lyophilized, for solution | New drug applications (NDA) | February 27, 2009 |
| Amneal Pharmaceuticals LLC | 6 | capsule | Generic drugs (ANDA) | April 3, 2015 |
| Ascend Laboratories, LLC | 6 | capsule | Generic drugs (ANDA) | April 28, 2017 |
| Camber Pharmaceuticals, Inc. | 6 | capsule | Generic drugs (ANDA) | August 23, 2024 |
| CivicaScript LLC | 6 | capsule | Generic drugs (ANDA) | August 10, 2026 |
| Devatis, Inc. | 6 | capsule | Generic drugs (ANDA) | April 28, 2017 |
| Eugia US LLC | 6 | injection, powder, lyophilized, for solution; injection, solution | Generic drugs (ANDA) | June 25, 2024 |
| Nivagen Pharmaceuticals, Inc. | 6 | capsule | Generic drugs (ANDA) | December 7, 2021 |
| Opko Pharmaceuticals, LLC | 6 | capsule | Generic drugs (ANDA) | October 31, 2026 |
| Rising Pharma Holdings, Inc. | 6 | capsule | Generic drugs (ANDA) | October 4, 2022 |
| Sun Pharmaceutical Industries, Inc. | 6 | capsule | Generic drugs (ANDA) | February 13, 2014 |
| Amneal Pharmaceuticals LLC | 5 | injection, powder, for solution; injection, powder, lyophilized, for solution | New drug applications (NDA) | April 18, 2025 |
| Azurity Pharmaceuticals, Inc. | 5 | capsule, gelatin coated; injection | New drug applications (NDA) | October 24, 2025 |
| Baxter Healthcare Company | 5 | injection, powder, for solution; injection | New drug applications (NDA) | December 15, 2022 |
| Gland Pharma Limited | 5 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | November 22, 2022 |
| Sagent Pharmaceuticals | 5 | injection, powder, lyophilized, for solution; injection, solution, concentrate | Generic drugs (ANDA) | June 15, 2023 |
| Archis Pharma LLC | 4 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | April 25, 2022 |
| BluePoint Laboratories | 4 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | July 11, 2024 |
| Fresenius Kabi USA, LLC | 4 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | January 15, 2023 |
| Apotex Corp. | 3 | injection, solution; injection, solution, concentrate | New drug applications (NDA) | June 30, 2026 |
| Carnegie Pharmaceuticals LLC | 3 | capsule | Generic drugs (ANDA) | November 10, 2025 |
| Cephalon, LLC | 3 | injection, powder, lyophilized, for solution; injection, solution | New drug applications (NDA) | December 8, 2015 |
| Fresenius Kabi USA, LLC | 3 | injection, powder, for solution; injection, powder, lyophilized, for solution | Generic drugs (ANDA) | January 28, 2003 |
| NextSource Biotechnology, LLC | 3 | capsule, gelatin coated | New drug applications (NDA) | August 18, 2014 |
| Wilshire Pharmaceuticals, Inc. | 3 | capsule, gelatin coated | New drug applications (NDA) | April 15, 2026 |
| Accord BioPharma Inc. | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | July 25, 2017 |
| Avyxa Pharma, LLC | 2 | injection, solution; injection | New drug applications (NDA) | September 25, 2026 |
| Baxter Healthcare Corporation | 2 | injection, powder, for solution | New drug applications (NDA) | December 30, 1988 |
| Dr. Reddy's Laboratories Inc. | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | November 1, 2022 |
| Novadoz Pharmaceuticals LLC | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | February 1, 2020 |
| Waylis Therapeutics LLC | 2 | tablet, film coated | New drug applications (NDA) | May 15, 2023 |
| Acrotech Biopharma Inc | 1 | injection, powder, lyophilized, for solution | New drug applications (NDA) | March 31, 2016 |
| Bryant Ranch Prepack | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | March 11, 2022 |
| Eagle Pharmaceuticals, Inc. | 1 | injection | New drug applications (NDA) | June 3, 2019 |
| Esteve Pharmaceuticals, S.A. | 1 | powder, for solution | Unapproved drugs for a shortage | July 10, 2025 |
| Helsinn Therapeutics (U.S.), Inc. | 1 | gel | New drug applications (NDA) | November 8, 2018 |
| Hospira, Inc. | 1 | injection, solution | Generic drugs (ANDA) | February 28, 2019 |
| Janssen Products, LP | 1 | injection, powder, lyophilized, for solution | New drug applications (NDA) | October 23, 2015 |
| Jazz Pharmaceuticals, Inc. | 1 | injection, powder, lyophilized, for solution | New drug applications (NDA) | June 15, 2020 |
| Leadiant Biosciences, Inc. | 1 | capsule | New drug applications (NDA) | December 27, 1985 |
| Pharmascience Inc. | 1 | injection | Generic drugs (ANDA) | May 19, 2017 |
| Slayback Pharma LLC | 1 | injection | New drug applications (NDA) | December 7, 2022 |
| SteriMax Inc. | 1 | powder, for solution | Unapproved drugs for a shortage | September 4, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 76 | 40.6% |
| Injection, powder, lyophilized, for solution | 61 | 32.6% |
| Injection, powder, for solution | 13 | 7% |
| Injection, solution | 10 | 5.3% |
| Injection | 10 | 5.3% |
| Capsule, gelatin coated | 9 | 4.8% |
| Tablet, film coated | 2 | 1.1% |
| Injection, solution, concentrate | 2 | 1.1% |
| Powder, for solution | 2 | 1.1% |
| Wafer | 1 | 0.5% |
| Gel | 1 | 0.5% |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.