PillFluocinolone Acetonide
Fluocinolone Acetonide
3 active makers
soon
soon
soon
soon
US acquisition costNADAC · per unit
Average across 2 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it3 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES, INC. | unknown | 2 | SUPPLYING |
| Fougera Pharmaceuticals, LLC | unknown | 1 | SUPPLYING |
| Lupin Pharmaceuticals,Inc. | unknown | 1 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Dec 30, 2025RECALLRecall (Class III): Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc…
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. — Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC — Nationwide within the USA
- Jan 15, 2019RECALLRecall (Class II): Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, I…
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient. — Recalling firm: LUPIN SOMERSET — Nationwide in the USA and Puerto Rico
- Oct 5, 2018RECALLRecall (Class II): Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore…
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis — Recalling firm: LUPIN SOMERSET — Nationwide in the USA
- Feb 22, 2017RECALLRecall (Class III): Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only,…
Chemical Contamination — Recalling firm: Novel Laboratories, Inc. — Nationwide