DrugDashboards

Nystatin

Nystatin · NYSTATIN 100000 U/g · Ointment · Topical · Bryant Ranch Prepack

NDC 63629-2516-01 · 15 g in 1 TUBE · 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

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

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 →

Where it's made

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

Regulatory

Application
ANDA207767
TE code
AT
Approval date
May 25, 2018
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 (Ointment)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackNYSTATIN 100000 U/gJul 15, 2026Sep 3, 2026
A-S Medication SolutionsNYSTATIN 100000 U/gJul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.NYSTATIN 100000 [USP'U]/gJul 15, 2026Sep 2, 2026
Bryant Ranch PrepackNYSTATIN 100000 [USP'U]/gJul 15, 2026Sep 2, 2026
Leading Pharma, LLCNYSTATIN 100000 [USP'U]/gJul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedNYSTATIN 100000 1/gJul 15, 2026Sep 2, 2026
Padagis Israel Pharmaceuticals LtdNYSTATIN 100000 [USP'U]/gJul 15, 2026Sep 2, 2026
Proficient Rx LPNYSTATIN 100000 [USP'U]/gJul 15, 2026Sep 2, 2026
Torrent Pharmaceuticals LimitedNYSTATIN 100000 U/gJul 15, 2026Sep 2, 2026
Viona Pharmaceuticals IncNYSTATIN 100000 U/gJul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedNYSTATIN 100000 U/gJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Nystatin — NDC 63629-2516-01," retrieved September 3, 2026, https://drugdashboards.com/drug/63629251601.

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