DrugDashboards

Fluocinolone Acetonide

Fluocinolone Acetonide · FLUOCINOLONE ACETONIDE .1 mg/mL · Solution · Topical · Lupin Pharmaceuticals,Inc.

NDC 43386-0069-60 · 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. The price has fallen 40% in a year, to $0.3706 per unit — and generics that get this cheap tend to get abandoned rather than defended.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Part D plans paid (avg)$0.7243per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$0.2756per MLweighted avg manufacturer price $0.1274 · Feb 1, 2023

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 51672-1365-04) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$0.3863per unit
middle half $0.3088$0.7797 · 5,301 plans · Apr 1, 2026
Est. net of rebates
≈ $0.3863
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
96%of plans cover it
tier 4 · prior auth 0% · step therapy 0% · qty limit 66%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

$0$1.00$2.00$3.00Mar 2016Jan 2022$0.3706
69 price points · per · last surveyed Invalid Date · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Medicaid spend (2022)

$802
16 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for fluocinolone acetonide (other) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA206422
TE code
AT
Approval date
Sep 2, 2015
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedJan 15, 2019
    LUPIN SOMERSETFailed 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.
  • Class II · TerminatedOct 5, 2018
    LUPIN SOMERSETFailed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
  • Class III · TerminatedFeb 22, 2017
    Novel Laboratories, Inc.Chemical Contamination

Manufacturers of Fluocinolone Acetonide (Solution)

LabelerStrengthFirst seenLast seen
Fougera Pharmaceuticals, LLCFLUOCINOLONE ACETONIDE .1 mg/mLJul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals,Inc.FLUOCINOLONE ACETONIDE .1 mg/mLJul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.FLUOCINOLONE ACETONIDE .1 mg/mLJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Fluocinolone Acetonide — NDC 43386-0069-60," retrieved September 3, 2026, https://drugdashboards.com/drug/43386006960.

Free to cite with attribution — see how the data is put together.