Data / Drug companies / Hydromorphone hydrochloride
Hydromorphone hydrochloride: 20 companies and 74 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Hydromorphone hydrochloride is listed in the FDA National Drug Code Directory by 20 companies, with 74 products in commercial distribution. 40 of the products (54.1%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; injection, solution; tablet, extended release, and the newest product started marketing on June 9, 2026.
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- Companies listing it
- 20
- Products
- 74
- Generic (ANDA) products
- 40 (54.1%)
- Application numbers
- 16
- Controlled substance schedule
- Schedule II
- Routes
- Oral, Intramuscular, Intravenous, Subcutaneous, Rectal
- Brand names
- Dilaudid
- openFDA record search
- api.fda.gov
Companies that list hydromorphone hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Hospira, Inc. | 9 | injection, solution | New drug applications (NDA) | January 29, 2024 |
| Rhodes Pharmaceuticals LLC | 8 | tablet; solution | Authorized generics (NDA) | May 15, 2017 |
| Hikma Pharmaceuticals USA Inc. | 7 | injection; injection, solution | Generic drugs (ANDA) | May 13, 2025 |
| Padagis US LLC | 5 | tablet, extended release; suppository | Generic drugs (ANDA) | May 22, 2015 |
| Ascent Pharmaceuticals, Inc. | 4 | tablet; solution | Generic drugs (ANDA) | May 4, 2019 |
| Camber Pharmaceuticals, Inc. | 4 | tablet, extended release | Generic drugs (ANDA) | September 24, 2020 |
| Fresenius Kabi USA, LLC | 4 | injection, solution | New drug applications (NDA) | December 15, 2017 |
| Trigen Laboratories, LLC | 4 | tablet, extended release | Generic drugs (ANDA) | September 15, 2016 |
| XLCare Pharmaceuticals, Inc. | 4 | tablet, extended release | Generic drugs (ANDA) | September 24, 2020 |
| American Health Packaging | 3 | tablet; solution | Generic drugs (ANDA) | September 1, 2021 |
| Asclemed USA Inc. | 3 | tablet | Authorized generics (NDA) | November 23, 2009 |
| Aurolife Pharma, LLC | 3 | tablet | Generic drugs (ANDA) | May 17, 2016 |
| Fresenius Kabi USA, LLC | 3 | injection, solution | New drug applications (NDA) | December 4, 2018 |
| SpecGx LLC | 3 | tablet | Generic drugs (ANDA) | December 23, 2004 |
| Teva Parenteral Medicines, Inc. | 3 | injection, solution | Generic drugs (ANDA) | January 18, 2011 |
| Bryant Ranch Prepack | 2 | suppository; tablet | Other unapproved drugs | November 23, 2009 |
| Bryant Ranch Prepack | 2 | tablet | Generic drugs (ANDA) | May 17, 2016 |
| Hikma Pharmaceuticals USA Inc. | 1 | solution | Generic drugs (ANDA) | March 1, 2012 |
| Redpharm Drug | 1 | tablet | Generic drugs (ANDA) | December 23, 2004 |
| St. Mary's Medical Park Pharmacy | 1 | tablet | Authorized generics (NDA) | June 9, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 25 | 33.8% |
| Injection, solution | 20 | 27% |
| Tablet, extended release | 16 | 21.6% |
| Injection | 6 | 8.1% |
| Solution | 5 | 6.8% |
| Suppository | 2 | 2.7% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 40 | 54.1% |
| New drug applications (NDA) | 20 | 27% |
| Authorized generics (NDA) | 11 | 14.9% |
| Other unapproved drugs | 3 | 4.1% |
Pharmacologic classes
| Class | Products |
|---|---|
| Opioid Agonist | 74 |
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.