Data / Drug companies / Morphine sulfate
Morphine sulfate: 31 companies and 150 products in the FDA NDC directory
Morphine sulfate is listed in the FDA National Drug Code Directory by 31 companies, with 150 products in commercial distribution. 107 of the products (71.3%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated, extended release; solution; capsule, extended release, and the newest product started marketing on July 30, 2026.
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- Companies listing it
- 31
- Products
- 150
- Generic (ANDA) products
- 107 (71.3%)
- Application numbers
- 29
- Controlled substance schedule
- Schedule II
- Routes
- Oral, Intravenous, Intramuscular, Rectal, Epidural
- Brand names
- MS Contin, Mitigo, Duramorph, Infumorph 200, Infumorph 500
- openFDA record search
- api.fda.gov
Companies that list morphine sulfate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 14 | tablet, film coated, extended release; suppository | Generic drugs (ANDA) | February 11, 2021 |
| Hikma Pharmaceuticals USA Inc. | 9 | injection; injection, solution | Generic drugs (ANDA) | April 18, 2025 |
| Upsher-Smith Laboratories, LLC | 9 | capsule, extended release; tablet | Generic drugs (ANDA) | July 22, 2019 |
| Rhodes Pharmaceuticals LLC | 8 | tablet, film coated, extended release | Generic drugs (ANDA) | May 15, 2017 |
| SpecGx LLC | 8 | tablet, extended release; tablet | Generic drugs (ANDA) | September 1, 2023 |
| Amneal Pharmaceuticals of New York LLC | 7 | capsule, extended release | Generic drugs (ANDA) | October 5, 2018 |
| Bryant Ranch Prepack | 7 | tablet, film coated, extended release; solution | Generic drugs (ANDA) | September 21, 2015 |
| Actavis Pharma, Inc. | 6 | capsule, extended release | Generic drugs (ANDA) | February 4, 2014 |
| Fresenius Kabi USA, LLC | 6 | injection, solution | New drug applications (NDA) | October 30, 2013 |
| Hospira, Inc. | 6 | injection, solution | New drug applications (NDA) | April 21, 2025 |
| Nortec Development Associates, Inc. | 6 | capsule, extended release | Generic drugs (ANDA) | April 7, 2009 |
| Precision Dose, Inc. | 6 | solution | New drug applications (NDA) | September 1, 2025 |
| American Health Packaging | 5 | solution | Generic drugs (ANDA) | May 1, 2026 |
| Bryant Ranch Prepack | 5 | tablet, film coated, extended release; tablet | Generic drugs (ANDA) | February 11, 2021 |
| Fresenius Kabi USA, LLC | 5 | injection, solution | New drug applications (NDA) | April 10, 2018 |
| Hikma Pharmaceuticals USA Inc. | 5 | solution; tablet | New drug applications (NDA) | March 17, 2008 |
| Lupin Pharmaceuticals,Inc. | 5 | tablet, film coated, extended release | Generic drugs (ANDA) | December 16, 2015 |
| Sun Pharmaceutical Industries, Inc. | 5 | tablet, film coated, extended release | Generic drugs (ANDA) | May 11, 2012 |
| Major Pharmaceuticals | 4 | tablet, film coated, extended release | Generic drugs (ANDA) | January 14, 2011 |
| Padagis US LLC | 4 | suppository | Other unapproved drugs | September 1, 1990 |
| American Health Packaging | 3 | solution; tablet | Generic drugs (ANDA) | February 1, 2026 |
| Winder Laboratories LLC | 3 | solution | Generic drugs (ANDA) | May 15, 2019 |
| American Health Packaging | 2 | tablet, film coated, extended release | Generic drugs (ANDA) | November 5, 2013 |
| Ascend Laboratories, LLC | 2 | tablet | Generic drugs (ANDA) | February 11, 2021 |
| Pai Holdings, LLC DBA Pai Pharma | 2 | solution | Generic drugs (ANDA) | September 15, 2025 |
| Piramal Critical Care Inc | 2 | injection | Generic drugs (ANDA) | February 25, 2019 |
| Redpharm Drug | 2 | tablet | Generic drugs (ANDA) | September 1, 2023 |
| Civica, Inc. | 1 | injection | Generic drugs (ANDA) | November 11, 2019 |
| Cranbury Pharmaceuticals, LLC | 1 | solution | Generic drugs (ANDA) | September 21, 2015 |
| International Medication Systems, Limited | 1 | injection | Generic drugs (ANDA) | January 20, 2022 |
| St. Mary's Medical Park Pharmacy | 1 | tablet | Generic drugs (ANDA) | July 30, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated, extended release | 41 | 27.3% |
| Solution | 26 | 17.3% |
| Capsule, extended release | 26 | 17.3% |
| Injection, solution | 19 | 12.7% |
| Tablet | 14 | 9.3% |
| Injection | 11 | 7.3% |
| Suppository | 8 | 5.3% |
| Tablet, extended release | 5 | 3.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 107 | 71.3% |
| New drug applications (NDA) | 35 | 23.3% |
| Other unapproved drugs | 8 | 5.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Opioid Agonist | 150 |
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.