Data / Drug companies / Fluocinolone acetonide
Fluocinolone acetonide: 17 companies and 42 products in the FDA NDC directory
Fluocinolone acetonide is listed in the FDA National Drug Code Directory by 17 companies, with 42 products in commercial distribution. 32 of the products (76.2%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are oil; cream; ointment, and the newest product started marketing on May 8, 2024.
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- Companies listing it
- 17
- Products
- 42
- Generic (ANDA) products
- 32 (76.2%)
- Application numbers
- 25
- Routes
- Topical, Auricular (otic), Intravitreal
- Brand names
- Synalar, Iluvien, Dermotic, Derma-Smoothe/fs, Flac Otic Oil, Derma-Smoothe/FS, Yutiq
- openFDA record search
- api.fda.gov
Companies that list fluocinolone acetonide
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 5 | oil | Generic drugs (ANDA) | April 2, 2021 |
| Ani Pharmaceuticals, Inc. | 3 | cream; ointment | Authorized generics (NDA) | May 8, 2024 |
| Bryant Ranch Prepack | 3 | oil | Generic drugs (ANDA) | April 2, 2021 |
| Cosette Pharmaceuticals, Inc. | 3 | cream; ointment | Generic drugs (ANDA) | November 5, 2018 |
| Padagis Israel Pharmaceuticals Ltd | 3 | oil | Generic drugs (ANDA) | October 4, 2017 |
| Quagen Pharmaceuticals LLC | 3 | oil | Generic drugs (ANDA) | April 2, 2021 |
| Rising Pharma Holdings, Inc. | 3 | oil | Generic drugs (ANDA) | September 14, 2016 |
| Royal Pharmaceuticals | 3 | oil | New drug applications (NDA) | November 9, 2005 |
| Sun Pharmaceutical Industries, Inc. | 3 | oil; solution | Generic drugs (ANDA) | May 19, 2016 |
| A-S Medication Solutions | 2 | oil | Generic drugs (ANDA) | June 14, 2017 |
| Ani Pharmaceuticals, Inc. | 2 | implant | New drug applications (NDA) | May 17, 2023 |
| Bryant Ranch Prepack | 2 | oil | Generic drugs (ANDA) | June 14, 2017 |
| E. Fougera & Co. a Division of Fougera Pharmaceuticals, LLC | 2 | solution; ointment | Generic drugs (ANDA) | December 16, 1982 |
| Medimetriks Pharmaceuticals, Inc. | 2 | ointment; cream | New drug applications (NDA) | September 27, 2012 |
| Amneal Pharmaceuticals LLC | 1 | oil | Generic drugs (ANDA) | September 22, 2015 |
| Lupin Pharmaceuticals,Inc. | 1 | solution | Generic drugs (ANDA) | September 2, 2015 |
| Patrin Pharma, Inc. | 1 | oil | Generic drugs (ANDA) | April 12, 2018 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Oil | 28 | 66.7% |
| Cream | 5 | 11.9% |
| Ointment | 4 | 9.5% |
| Solution | 3 | 7.1% |
| Implant | 2 | 4.8% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 32 | 76.2% |
| New drug applications (NDA) | 7 | 16.7% |
| Authorized generics (NDA) | 3 | 7.1% |
Pharmacologic classes
| Class | Products |
|---|---|
| Corticosteroid | 42 |
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.