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Nystatin Cream

Nystatin Cream · NYSTATIN 100000 [USP'U]/g · Cream · Topical · Crown Laboratories

NDC 00316-0221-15 · 1 TUBE in 1 CARTON / 15 g in 1 TUBE · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. The price has held steady around $0.2999 per unit over the past year.

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

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

$0$0.2$0.4Mar 2018Mar 2020$0.2999
25 price points · per · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$12.99
Reported to Texas DSHS · 2026 annual filing · Crown Laboratories, Inc.

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

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 →

Where it's made

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

Regulatory

Application
ANDA207733
TE code
AT
Approval date
Sep 26, 2017
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedJun 10, 2020
    Crown LaboratoriesSubpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
  • Class II · TerminatedJun 10, 2020
    Crown LaboratoriesSubpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.

Manufacturers of Nystatin Cream (Cream)

LabelerStrengthFirst seenLast seen
Cosette Pharmaceuticals, Inc.NYSTATIN 100000 [USP'U]/gJul 15, 2026Sep 2, 2026
Crown LaboratoriesNYSTATIN 100000 [USP'U]/gJul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals, Inc.NYSTATIN 100000 [USP'U]/gJul 15, 2026Sep 2, 2026
Proficient Rx LPNYSTATIN 100000 [USP'U]/gJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Nystatin Cream — NDC 00316-0221-15," retrieved September 3, 2026, https://drugdashboards.com/drug/00316022115.

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