Data / Drug companies / Fentanyl citrate
Fentanyl citrate: 5 companies and 17 products in the FDA NDC directory
Fentanyl citrate is listed in the FDA National Drug Code Directory by 5 companies, with 17 products in commercial distribution. 3 of the products (17.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection; injection, solution, and the newest product started marketing on August 29, 2025.
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- Companies listing it
- 5
- Products
- 17
- Generic (ANDA) products
- 3 (17.6%)
- Application numbers
- 4
- Controlled substance schedule
- Schedule II
- Routes
- Intravenous, Intramuscular
- openFDA record search
- api.fda.gov
Companies that list fentanyl citrate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 8 | injection | New drug applications (NDA) | August 29, 2025 |
| Civica, Inc. | 3 | injection | New drug applications (NDA) | October 7, 2020 |
| Fresenius Kabi USA, LLC | 3 | injection, solution | Generic drugs (ANDA) | January 15, 2021 |
| Hospira, Inc. | 2 | injection, solution | New drug applications (NDA) | December 6, 2016 |
| Phlow Corporation | 1 | injection | New drug applications (NDA) | January 11, 2023 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection | 12 | 70.6% |
| Injection, solution | 5 | 29.4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 14 | 82.4% |
| Generic drugs (ANDA) | 3 | 17.6% |
Pharmacologic classes
| Class | Products |
|---|---|
| Opioid Agonist | 17 |
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.