Question 1

What is Fluocinolone Acetonide used for?

Accepted Answer

Fluocinolone Acetonide reduces inflammation and suppresses immune responses, used across many conditions.

Question 2

Is there a generic for Fluocinolone Acetonide?

Accepted Answer

Yes. 26 ANDAs filed at FDA, 12 generic manufacturers currently shipping.

Question 3

How much does my plan pay for Fluocinolone Acetonide?

Accepted Answer

Across 329 Part D plans, Fluocinolone Acetonide averages $0.475/unit (NADAC). Lowest available: $0.171/unit. Highest in distribution: $1.12/unit.

Question 4

Is Fluocinolone Acetonide on the FDA shortage list?

Accepted Answer

No. Fluocinolone Acetonide is not currently on the FDA Drug Shortage Database.

Question 5

What drug class is Fluocinolone Acetonide in?

Accepted Answer

Fluocinolone Acetonide is in the Corticosteroid class. See related drugs in this class at /class/corticosteroid.

Question 6

What is the brand name for Fluocinolone Acetonide?

Accepted Answer

Fluocinolone Acetonide is sold under brand names: DERMA-SMOOTHE/FS, DERMOTIC, Flac Otic Oil, Iluvien, Retisert, Synalar, YUTIQ.

Question 7

Is DERMA-SMOOTHE/FS the same as Fluocinolone Acetonide?

Accepted Answer

Yes. DERMA-SMOOTHE/FS is a brand name for Fluocinolone Acetonide. The generic version is identical in active ingredient, dose, and FDA-approved indications. Pricing differs substantially: generic Fluocinolone Acetonide typically prices well below brand DERMA-SMOOTHE/FS.

Question 8

How much does Medicare spend on Fluocinolone Acetonide per year?

Accepted Answer

Medicare Part D spent $10.7M on Fluocinolone Acetonide in CY2024, across 214K prescriptions and 138K unique beneficiaries.

Question 9

Why is there a spread between low and average NADAC for Fluocinolone Acetonide?

Accepted Answer

The 3× spread between lowest NADAC ($0.171/unit on generic NDCs) and average NADAC ($0.475/unit across all NDCs) reflects that brand-tier NDCs are still in distribution at higher prices. Most plans haven't migrated utilization toward the generic NDCs yet. For plans, this is the structural source of within-molecule savings opportunity.

Question 10

What can I switch to instead of Fluocinolone Acetonide?

Accepted Answer

Same-class alternatives include: Triamcinolone Acetonide, Prednisone, Hydrocortisone. Whether substitution is clinically appropriate depends on patient indication, dose schedule, and contraindications — that is a P&T committee decision. The federal data shows cost and competition; clinical equivalence is not asserted here.

Question 11

Why isn't Fluocinolone Acetonide cheaper if there's no PA friction?

Accepted Answer

Fluocinolone Acetonide has 12 generic manufacturers and zero prior-authorization barriers across 329 Part D plans. Why it isn't already cheaper on most plans: tier placement and PBM contract structure, not clinical or supply factors. Moving the molecule to a lower formulary tier captures the savings — see leak report for sizing.

Question 12

When did the most recent Fluocinolone Acetonide generic get approved?

Accepted Answer

The most recent ANDA approval for Fluocinolone Acetonide is NOVEL LABORATORIES INC (ANDAANDA207347, approved 2023-08-07).

Question 13

When was Fluocinolone Acetonide first FDA approved?

Accepted Answer

Fluocinolone Acetonide received its first FDA approval on 1982-12-16.

Fluocinolone Acetonide (DERMA-SMOOTHE/FS)

$10.7M in CY2024 Part D spend214K claims · 138K beneficiaries · 329 plans surveyed

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