DrugDashboards

Flucytosine

Flucytosine · FLUCYTOSINE 250 mg/1 · Capsule · Oral · Laurus Labs Limited

NDC 42385-0983-01 · 100 CAPSULE in 1 BOTTLE · ANDA · View full market →

The short version

10 companies supply this market — deep enough that no single failure threatens the supply.

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

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 43386-0771-01) — 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
$24.41per unit
middle half $13.19$46.80 · 5,481 plans · Apr 1, 2026
Est. net of rebates
≈ $24.41
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 52% · step therapy 0% · qty limit 0%

*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

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

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

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $2,443.22 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA218005
TE code
AB
Approval date
Jul 23, 2025
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Flucytosine (Capsule)

LabelerStrengthFirst seenLast seen
Aurobindo Pharma LimitedFLUCYTOSINE 250 mg/1Jul 15, 2026Sep 3, 2026
American Health PackagingFLUCYTOSINE 250 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingFLUCYTOSINE 500 mg/1Jul 15, 2026Sep 2, 2026
AvPAKFLUCYTOSINE 500 mg/1Jul 15, 2026Sep 2, 2026
AvPAKFLUCYTOSINE 250 mg/1Jul 15, 2026Sep 2, 2026
Bausch Health US LLCFLUCYTOSINE 500 mg/1Jul 15, 2026Sep 2, 2026
Bausch Health US LLCFLUCYTOSINE 250 mg/1Jul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.FLUCYTOSINE 250 mg/1Jul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.FLUCYTOSINE 500 mg/1Jul 15, 2026Sep 2, 2026
Laurus Labs LimitedFLUCYTOSINE 250 mg/1Jul 15, 2026Sep 2, 2026
Laurus Labs LimitedFLUCYTOSINE 500 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals,Inc.FLUCYTOSINE 250 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals,Inc.FLUCYTOSINE 500 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsFLUCYTOSINE 250 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsFLUCYTOSINE 500 mg/1Jul 15, 2026Sep 2, 2026
Novel Laboratories, Inc.FLUCYTOSINE 500 mg/1Jul 15, 2026Sep 2, 2026
Novel Laboratories, Inc.FLUCYTOSINE 250 mg/1Jul 15, 2026Sep 2, 2026
Sigmapharm Laboratories, LLCFLUCYTOSINE 500 mg/1Jul 15, 2026Sep 2, 2026
Sigmapharm Laboratories, LLCFLUCYTOSINE 250 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedFLUCYTOSINE 500 mg/1Jul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Flucytosine — NDC 42385-0983-01," retrieved September 3, 2026, https://drugdashboards.com/drug/42385098301.

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