DrugDashboards

Nystatin

Nystatin · NYSTATIN 100000 [USP'U]/mL · Suspension · Oral · Preferred Pharmaceuticals Inc.

NDC 68788-8561-04 · 473 mL in 1 BOTTLE · ANDA · View full market →

The short version

17 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 00121-0868-16) — 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
$0.0896per unit
middle half $0.0696$0.1463 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $0.0896
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 2 · prior auth 0% · step therapy 0% · qty limit 1%

*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 2 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.

90-day shortage risk (model v2)

0.2%chance of a new FDA shortage posting for nystatin (other) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market · 1 Class I/II recall(s) in 12 months

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 →

Regulatory

Application
ANDA214346
TE code
AA
Approval date
Mar 10, 2022
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 Nystatin (Suspension)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsNYSTATIN 100000 [USP'U]/mLJul 15, 2026Sep 3, 2026
Pharmaceutical Associates, Inc.NYSTATIN 100000 [USP'U]/mLJul 15, 2026Sep 3, 2026
American Health PackagingNYSTATIN 100000 [USP'U]/mLJul 15, 2026Sep 2, 2026
Bryant Ranch PrepackNYSTATIN 100000 U/mLJul 15, 2026Sep 2, 2026
Bryant Ranch PrepackNYSTATIN 100000 [USP'U]/mLJul 15, 2026Sep 2, 2026
Chartwell Governmental & Specialty RX, LLCNYSTATIN 100000 U/mLJul 15, 2026Sep 2, 2026
Chartwell RX, LLCNYSTATIN 100000 U/mLJul 15, 2026Sep 2, 2026
Genus Lifesciences Inc.NYSTATIN 100000 [USP'U]/mLJul 15, 2026Sep 2, 2026
Kanchan Healthcare IncNYSTATIN 100000 U/mLJul 15, 2026Sep 2, 2026
Leading Pharma, LLCNYSTATIN 100000 [USP'U]/mLJul 15, 2026Sep 2, 2026
Major PharmaceuticalsNYSTATIN 100000 [USP'U]/mLJul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals,Inc.NYSTATIN 100000 [USP'U]/mLJul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals Inc.NYSTATIN 100000 [USP'U]/mLJul 15, 2026Sep 2, 2026
Xttrium Laboratories, Inc.NYSTATIN 100000 [USP'U]/mLJul 15, 2026Sep 2, 2026
Cardinal Health 107, LLCNYSTATIN 100000 [USP'U]/mLJul 15, 2026Aug 31, 2026
PAI Holdings, LLC dba PAI PharmaNYSTATIN 100000 [USP'U]/mLJul 15, 2026Aug 31, 2026
Atlantic Biologicals Corp.NYSTATIN 100000 [USP'U]/mLJul 15, 2026Aug 29, 2026
Kesin Pharma CorporationNYSTATIN 100000 U/mLJul 15, 2026Aug 28, 2026
Taro Pharmaceuticals U.S.A., Inc.NYSTATIN 100000 [USP'U]/mLJul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Nystatin — NDC 68788-8561-04," retrieved September 3, 2026, https://drugdashboards.com/drug/68788856104.

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