Drug
Who makes fluocinolone acetonide?
17 companies list fluocinolone acetonide as a human prescription drug, including under the names DERMOTIC, Derma-Smoothe/FS, Iluvien, Retisert, Synalar, YUTIQ, Flac Otic Oil. Forms: cream; implant; oil; ointment; solution. Routes: auricular (otic), intravitreal, topical.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing fluocinolone acetonide
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | oil | ANDAANDA202847, ANDA202848, ANDA212760 | 10 | 1 |
| ANI Pharmaceuticals, Inc.United States | cream; implant; ointment | NDA, NDA AUTHORIZED GENERICNDA012787, NDA013960, NDA201923 | 5 | 1 |
| Sun Pharmaceutical Industries LimitedIndia | oil; solution | ANDAANDA089124, ANDA202368, ANDA209336 | 3 | 13 |
| Padagis Israel Pharmaceuticals LtdUnited States | oil | ANDAANDA202847, ANDA202848, ANDA202849 | 3 | 2 |
| QUAGEN PHARMACEUTICALS LLCUnited States | oil | ANDAANDA212760, ANDA212761, ANDA212762 | 3 | 2 |
| Rising Pharma Holdings, Inc.United States | oil | ANDAANDA090982, ANDA203377, ANDA203378 | 3 | 1 |
| Cosette Pharmaceuticals, Inc. | cream; ointment | ANDAANDA089524, ANDA089526, ANDA210747 | 3 | 0 |
| Royal Pharmaceuticals, LLC | oil | NDANDA019452 | 3 | 0 |
| Glenmark Pharmaceuticals Inc., USAIndia | oil | ANDAANDA210539, ANDA211815 | 2 | 9 |
| International Medication Systems, Ltd.United States | oil | ANDAANDA090982, ANDA202848 | 2 | 3 |
| Medimetriks Pharmaceuticals, Inc. | cream; ointment | NDANDA012787, NDA013960 | 2 | 0 |
| Lupin LimitedIndia | solution | ANDAANDA206422 | 1 | 14 |
| Bausch & Lomb Ireland LimitedUnited States | implant | NDANDA021737 | 1 | 4 |
| Fougera Pharmaceuticals, LLCUnited States | solution | ANDAANDA088167 | 1 | 2 |
| Amneal Ireland LimitedIreland | oil | ANDAANDA201759 | 1 | 1 |
| Patrin Pharma, IncUnited States | oil | ANDAANDA210736 | 1 | 1 |
| E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | ointment | ANDAANDA088168 | 1 | 0 |
Bulk ingredient listings
- ASCLEMED USA INC. DBA ENOVACHEMUnited States · 1 NDC
- Farmabios S.p.A.Italy · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Sicor S.r.l. · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Orange Book patents
3 unexpired patents list fluocinolone acetonide as the active ingredient, expiring between Aug 2027 and Nov 2028. Application holder: ALIMERA SCIENCES INC.
Enquiry
Common questions
- Who makes fluocinolone acetonide?
- 17 companies list fluocinolone acetonide as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, ANI Pharmaceuticals, Inc., Sun Pharmaceutical Industries Limited, Padagis Israel Pharmaceuticals Ltd, QUAGEN PHARMACEUTICALS LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic DERMOTIC?
- 13 companies list fluocinolone acetonide under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies fluocinolone acetonide active ingredient?
- 6 companies list fluocinolone acetonide as a bulk ingredient, including ASCLEMED USA INC. DBA ENOVACHEM, Farmabios S.p.A., MEDISCA Inc., Professional Compounding Centers of America dba PCCA.