PillFluocinolone Acetonide
Brands: Dermotic · Flac Otic Oil · Fluocinolone Acetonide
7 active makers
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US acquisition costNADAC · per unit
Average across 4 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 it7 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 |
|---|---|---|---|
| Bryant Ranch Prepack | repackager | 2 | SUPPLYING |
| Rising Pharma Holdings, Inc. | unknown | 1 | SUPPLYING |
| Padagis Israel Pharmaceuticals Ltd | unknown | 1 | SUPPLYING |
| Glenmark Pharmaceuticals Inc., USA | unknown | 1 | SUPPLYING |
| Royal Pharmaceuticals | unknown | 1 | SUPPLYING |
| QUAGEN PHARMACEUTICALS LLC | unknown | 1 | SUPPLYING |
| Patrin Pharma, Inc. | unknown | 1 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Jan 4, 2024RECALLRecall (Class II): Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: G…
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol — Recalling firm: Glenmark Pharmaceuticals Inc., USA — USA Nationwide
- May 21, 2021RECALLRecall (Class II): DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceutical…
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper. — Recalling firm: Hill Dermaceuticals, Inc. — Nationwide within the United States
- Apr 13, 2018RECALLRecall (Class II): Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton…
Subpotent Drug — Recalling firm: Lyne Laboratories, Inc. — to be entered
- Jan 31, 2014RECALLRecall (Class III): ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Der…
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. — Recalling firm: Hill Dermaceuticals, Inc. — Nationwide and Puerto Rico