Product Information
URSODIOL 250 MG TABLET is a generic product labeled by Major Pharmaceuticals, priced at $0.4495 per EA under NDC 00904689004. Its NADAC has been published 367 times since Sep 25, 2019.
FDA first approved this application on Feb 14, 2013. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
250 mg/1
Manufacturer
Major PharmaceuticalsNDC
00904689004
Classification
Generic
Dosage Form
TABLET, FILM COATED
Route
ORAL
Effective Date
9/23/2026
Active Ingredients
URSODIOLApproval Type
Generic (ANDA)
FDA Application
ANDA202540FDA Approved
2/14/2013
TE Code
AB
On Market Since
8/1/2013
Pharmacological Classes
Price Statistics
The NADAC for URSODIOL 250 MG TABLET has been published 367 times since Sep 25, 2019, and over the history we have for it it has declined 53.6%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.4495 per EA |
|---|---|
| All-time high | $1.0144 (Apr 15, 2020) |
| All-time low | $0.2571 (Jul 17, 2024) |
| 52-week high | $0.4550 |
| 52-week low | $0.3403 |
| Median price | $0.5137 |
| Average price | $0.5827 |
| Largest weekly change | +77.9% (Aug 21, 2024) |
| Weeks tracked | 367 |
| Tracking since | Sep 25, 2019 |
Generic Alternatives
The matcher finds 6 manufacturers offering a NADAC-published product with this drug's active ingredient and strength in a comparable dosage form (cheapest from each manufacturer, up to 10 shown below). Switching to the cheapest would cut per-unit acquisition cost by roughly 4% at current NADAC. These are candidates to verify clinically, not guaranteed substitutes — see our generic drug prices guide.
Related Drugs
Same classification
Continue researching this drug
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Manufacturer
Major Pharmaceuticals manufacturer profile
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Drug market
Ursodiol market comparison
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Therapeutic class
Bile Acid class view
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Trend hub
Latest market trends
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Guide
Understanding NADAC pricing
Use the explainer when you need context on how CMS publishes NADAC and how to interpret the number on this page.
Frequently asked questions
What is the NADAC price of URSODIOL 250 MG TABLET?
The current National Average Drug Acquisition Cost (NADAC) for URSODIOL 250 MG TABLET, manufactured by Major Pharmaceuticals, is $0.4495 per EA (NDC 00904689004), effective Sep 30, 2026.
How has the price of URSODIOL 250 MG TABLET changed over time?
Over the history we have for it, the NADAC for URSODIOL 250 MG TABLET has declined 53.6%. It has been tracked across 367 weekly CMS publications since Sep 25, 2019.
What are the highest and lowest recorded NADAC prices for URSODIOL 250 MG TABLET?
Since Sep 25, 2019, the NADAC for URSODIOL 250 MG TABLET has ranged from a low of $0.2571 (Jul 17, 2024) to a high of $1.0144 (Apr 15, 2020), with a median of $0.5137 per EA.
Are there cheaper alternatives to URSODIOL 250 MG TABLET?
Yes. 6 manufacturers publish a NADAC-priced product with the same active ingredient and strength in a comparable dosage form. The lowest-priced option, URSODIOL 250 MG TABLET, is $0.4295 per EA — about 4% below URSODIOL 250 MG TABLET.
Who manufactures URSODIOL 250 MG TABLET?
URSODIOL 250 MG TABLET (NDC 00904689004) is labeled by Major Pharmaceuticals, and CMS classifies it as a generic product.