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Ursodiol Capsule shortage

Ursodiol Capsule is currently listed in shortage by the FDA. The FDA lists 1 affected product. This page was last refreshed from FDA data on Oct 3, 2026.

To Be Discontinued ⚠ Supply risk: High Other 1 product 180 days First posted Apr 6, 2026 Updated Apr 6, 2026
Here’s the bottom line

Strides Pharma is permanently stopping its ursodiol 300 mg capsules. Other manufacturers — including Lannett, Actavis, Major Pharmaceuticals, and KVK-Tech — still list ursodiol 300 mg capsules as available.

Don’t stop or change your therapy on your own — talk with your prescriber about the plan that fits you, and ask your pharmacist what’s actually available (see options).

Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →
1
Affected NDCs
1
Reporting manufacturers
0/1
Reporting mfrs supplying
0/1
Affected strengths supplied
180
Days in shortage
1,218
Medicaid Rx (2026)
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Oct 3, 2026 · today

What’s in shortage — at a glance

These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Ursodiol Capsule. Other makers that haven’t reported a problem are shown in the green card below.

Availability of affected NDCs
From the FDA shortage report
1 NDCs
To be discontinued 1
Affected strengths still supplied
Among manufacturers reporting this shortage
0/1 strengths
No supply 1
FDA-reporting manufacturers with supply
Among manufacturers reporting this shortage
0/1 makers
No supply 1
✓ Other manufacturers not reporting a shortage
Still-marketed Ursodiol Capsule from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
Lannett Company, Inc. Actavis Pharma, Inc. Major Pharmaceuticals KVK-Tech, Inc. PuraCap Laboratories, LLC AvKARE Laurus Labs Limited Epic Pharma, LLC PD-Rx Pharmaceuticals, Inc. AvPAK Golden State Medical Supply, Inc. Aurobindo Pharma Limited
Plus 18 alternative dosage forms of Ursodiol.
See all other options & details →
Shortage timeline
  1. Apr 6, 2026
    Currently in shortage
    1 of 1 product affected.
  2. Apr 6, 2026
    First reported to the FDA
    1 product first listed.

Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.

What exactly is on backorder — by manufacturer

Manufacturer: Strides Pharma Inc. 📞 877-244-9825 1 NDC click to expand
Status NDC / product Strength Availability Related information Reason
To Be Discontinued Ursodiol, Capsule, 300 mg (NDC 64380-844-06) NDC 64380-0844-06 — — Discontinuation of the manufacture of the drug —

These rows are manufacturer reports to the FDA for Ursodiol Capsule — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Ursodiol Capsule? options further down this page.

Why is Ursodiol Capsule in shortage?

Strides Pharma Inc. has reported to the FDA that they are permanently stopping the manufacturing of their 300 mg ursodiol capsules (the 6-capsule package, NDC 64380-844-06). This means this specific product from this company will no longer be made going forward.

It's worth noting that Strides Pharma did not share a more detailed public reason for why they made this decision — just that they are discontinuing manufacture of this particular product. This report only reflects what Strides Pharma has filed with the FDA, so it speaks only to their version of this medication.

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Ursodiol Capsule, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.

What should I do if I take Ursodiol Capsule?

Ursodiol 300 mg capsules are currently on the FDA drug-shortage list, so I want to walk you through what this means and how to keep your treatment on track.

The affected strength is the 300 mg capsule, and right now there is no available source reported for it from the manufacturer that filed this record. The reason listed is a discontinuation of manufacture by Strides Pharma. Because this is marked "to be discontinued," this particular supply problem may be permanent rather than a short-term dip. That said, this report reflects only one manufacturer — several other companies still make the same medicine, so it may remain available elsewhere.

Here is how I would approach it:

  • Do not stop, skip, or change your dose on your own. Continuing your medicine as prescribed is important.
  • Ask your pharmacy to check wholesalers and other manufacturers. Ursodiol 300 mg is made by several other companies (for example, Lannett, Actavis, Major, Aurobindo, and others), so your pharmacy may be able to source the same medicine from a different maker — though it may not be in local stock immediately.
  • If your exact capsule cannot be found, talk with your prescriber or pharmacist about the best next step for you.

Manufacturer contact numbers are listed on this page for reference; your pharmacy usually handles those calls. This is general, national information and may not match your local pharmacy's actual stock.

See “Where else can I get Ursodiol Capsule?” below ↓ The same medicine from manufacturers not reporting a shortage, alternative dosage forms, and therapeutic equivalents with pricing.
If you are a patient:
  • Don’t stop or change the medication on your own — talk to your prescriber first.
  • If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
  • Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
  • Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Keep reading
Our full Ursodiol guide

Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.

Read the Ursodiol guide →

Where else can I get Ursodiol Capsule?

FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Ursodiol Capsule is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.

Same medicine, other manufacturers (not reported short)

Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:

ProductStrengthForm / routeManufacturerNDC
Ursodiol URSODIOL 300 mg/1 Capsule · Oral Lannett Company, Inc. 00527-1326-01
Ursodiol URSODIOL 300 mg/1 Capsule · Oral Actavis Pharma, Inc. 00591-3159-00
Ursodiol URSODIOL 300 mg/1 Capsule · Oral Major Pharmaceuticals 00904-6221-06
Ursodiol URSADIOL 300 mg/1 Capsule · Oral KVK-Tech, Inc. 10702-0237-01
Ursodiol URSODIOL 300 mg/1 Capsule · Oral PuraCap Laboratories, LLC 24658-0780-01
Ursodiol URSODIOL 300 mg/1 Capsule · Oral AvKARE 42291-0923-01
Ursodiol URSODIOL 300 mg/1 Capsule · Oral Laurus Labs Limited 42385-0946-01
Ursodiol URSODIOL 300 mg/1 Capsule · Oral Epic Pharma, LLC 42806-0503-01
Ursodiol URSADIOL 300 mg/1 Capsule · Oral PD-Rx Pharmaceuticals, Inc. 43063-0871-01
Ursodiol URSODIOL 300 mg/1 Capsule · Oral AvPAK 50268-0797-15
Ursodiol URSODIOL 300 mg/1 Capsule · Oral Golden State Medical Supply, Inc. 51407-0754-01
Ursodiol URSODIOL 300 mg/1 Capsule · Oral Aurobindo Pharma Limited 59651-0421-01

Alternative dosage forms of Ursodiol

A different form of the same drug (for example a solution when capsules are short). A form change is a clinical decision — ask your prescriber:

Therapeutic equivalents & pricing 24 productsclick to expand

Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.

ProductManufacturerPackageNADAC $/unitAB ratingAvailability
Ursodiol 300 mgNDC 50268-0797-15 AvPAK 50 capsules $0.416 save 3% — Availability likely
Ursodiol 300 mgNDC 72664-0217-01 VGYAAN 100 capsules $0.421 save 2% AB Availability likely
Ursodiol 300 mgNDC 00527-1326-01 Lannett 100 capsules $0.429 AB Availability likely
Ursodiol 300 mgNDC 00591-3159-01 Actavis 100 capsules $0.429 — Availability likely
Ursodiol 300 mgNDC 00904-6221-06 Major 50 capsules $0.429 AB Availability likely
Ursodiol 300 mgNDC 10702-0237-01 KVK-Tech, 100 capsules $0.429 AB Availability likely
Ursodiol 300 mgNDC 24658-0780-01 PuraCap 100 capsules $0.429 AB Availability likely
Ursodiol 300 mgNDC 42385-0946-01 Laurus 100 capsules $0.429 AB Availability likely
Ursodiol 300 mgNDC 42806-0503-01 Epic 100 capsules $0.429 AB Availability likely
Ursodiol 300 mgNDC 59651-0421-01 Aurobindo 100 capsules $0.429 AB Availability likely
Ursodiol 300 mgNDC 60687-0100-01 American 100 capsules $0.429 AB Availability likely
Ursodiol 300 mgNDC 62135-0430-60 Chartwell 60 capsules $0.429 AB Availability likely
Ursodiol 300 mgNDC 64380-0844-06 Strides 100 capsules $0.429 AB Availability likely
Ursodiol 300 mgNDC 69238-1540-01 Amneal 100 capsules $0.429 — Availability likely
Ursodiol 300 mgNDC 70710-1483-01 Zydus 100 capsules $0.429 AB Availability likely
Ursodiol 300 mgNDC 72603-0613-01 NorthStar 100 capsules $0.429 AB Availability likely
Ursodiol 300 mgNDC 24658-0999-10 PuraCap 1000 capsules — AB FDA listed
Ursodiol 300 mgNDC 42291-0923-01 AvKARE 100 capsules — AB FDA listed
Ursodiol 300 mgNDC 43063-0871-01 PD-Rx 100 capsules — AB FDA listed
Ursodiol 300 mgNDC 51407-0754-01 Golden 100 capsules — AB FDA listed
Ursodiol 300 mgNDC 70771-1524-01 Zydus 100 capsules — AB FDA listed
Ursodiol 300 mgNDC 72162-2168-01 Bryant 100 capsules — AB FDA listed
Ursodiol 300 mgNDC 72162-2619-01 Bryant 100 capsules — AB FDA listed
Ursodiol 300 mgNDC 50268-0864-13 AvPAK 30 capsules — AB FDA listed

Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.

Other drugs in the same treatment class

These are different medicines — not other versions of Ursodiol Capsule — that fall in the same broad treatment class (bile salts) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.

Identity & classification

GCN Seq No 003095
GCN 01070
HICL code 001370
Ingredient (HICL) Ursodiol
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D7
Therapeutic class — intermediate (HIC2) Act Primarily On Liver/Biliary Tract
HIC3 code D7A
Therapeutic class — specific (HIC3) Bile Salts
AHFS code 56:14.00.00
AHFS class Cholelitholytic Agents
FDB label name URSODIOL 300 MG CAPSULE
FDB brand name Ursodiol
Legend status F — Federal legend — prescription drug or device
Where does this data come from?
Identity codes come from First Databank (FDB) (HICL ingredient, HIC1–3 therapeutic-class hierarchy, GCN, AHFS class, legend status) and Medi-Span GPI, mapped from a representative affected NDC. Licensed reference data — for identification only.

Other other shortages

Ursodiol Capsule shortage FAQs

Is Ursodiol Capsule in shortage?
Yes — the FDA currently lists Ursodiol Capsule in shortage (status: “To Be Discontinued”, first reported Apr 6, 2026). 1 of 1 product is affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Which products are affected?
Ursodiol, Capsule, 300 mg (NDC 64380-844-06) (NDC 64380-0844-06). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Ursodiol Capsule be available again?
The FDA does not publish a guaranteed restock date, and no estimated-recovery note is on file. Availability can change daily — confirm with your pharmacy.
Can I still get Ursodiol somewhere?
Other manufacturers (Lannett Company, Inc., Actavis Pharma, Inc., Major Pharmaceuticals and others) still market it and have not reported a shortage. 18 alternative dosage forms of Ursodiol are also listed. See “Where else can I get Ursodiol Capsule?” above — stock still varies by pharmacy.
What should I do if I take Ursodiol Capsule?
Don’t stop or change it on your own. Ask your pharmacist whether they can order it from another manufacturer or a different strength/package size, and ask your prescriber about a long-term plan before your supply runs out.

Still have a question about the Ursodiol Capsule shortage?

Ask a pharmacist about this shortage →
How to read the Supply-Risk rating
Low (1–2)Multiple manufacturers still supplying and most strengths or pack sizes sourceable.
Medium (3)Some constraint — fewer suppliers or a notable share of NDCs unavailable.
High (4–5)Down to a single source, most strengths or pack sizes unsourceable, or a long-running outage.
Where does this data come from?
Shortage records come from the FDA Drug Shortages Database API via openFDA (/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.
Data structure & sourcing designed and verified by Dr. Brian Staiger, PharmD.
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