DrugDashboards

Ursodiol

Ursodiol · URSODIOL 300 mg/1 · Capsule · Oral · Bryant Ranch Prepack

NDC 72162-2619-01 · 100 CAPSULE in 1 BOTTLE · ANDA · View full market →

The short version

22 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 00527-1326-01) — 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
$0.8092per unit
middle half $0.6735$1.31 · 5,452 plans · Apr 1, 2026
Est. net of rebates
≈ $0.8092
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
99%of plans cover it
tier 3 · prior auth 0% · 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 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)

0.1%chance of a new FDA shortage posting for ursodiol (oral solid) in the next 90 days

sole-source market

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
ANDA214849
TE code
AB
Approval date
Nov 28, 2022
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation Ursodiol, Capsule, 300 mg (NDC 64380-844-06)Apr 6, 2026

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Ursodiol (Capsule)

LabelerStrengthFirst seenLast seen
AvPAKURSODIOL 300 mg/1Jul 15, 2026Sep 3, 2026
American Health PackagingURSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCURSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
AvKAREURSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCURSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
Epic Pharma, LLCURSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
FH2 Pharma LLCURSODIOL 400 mg/1Jul 15, 2026Sep 2, 2026
FH2 Pharma LLCURSODIOL 200 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.URSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
Intra-Sana LaboratoriesURSODIOL 400 mg/1Jul 15, 2026Sep 2, 2026
Intra-Sana LaboratoriesURSODIOL 200 mg/1Jul 15, 2026Sep 2, 2026
Lannett Company, Inc.URSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
Laurus Labs LimitedURSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsURSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
NorthStar Rx LLCURSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
Pangea Pharmaceuticals, LLCURSODIOL 150 mg/1Jul 15, 2026Sep 2, 2026
Strides Pharma Science LimitedURSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
VGYAAN Pharmaceuticals LLCURSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedURSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals (USA) Inc.URSODIOL 300 mg/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.URSODIOL 300 mg/1Jul 15, 2026Aug 31, 2026
Aurobindo Pharma LimitedURSODIOL 300 mg/1Jul 15, 2026Aug 31, 2026
Bryant Ranch PrepackURSODIOL 300 mg/1Jul 15, 2026Aug 31, 2026
PuraCap Laboratories, LLCURSODIOL 300 mg/1Jul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Ursodiol — NDC 72162-2619-01," retrieved September 3, 2026, https://drugdashboards.com/drug/72162261901.

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