Product Information
URSODIOL 300 MG CAPSULE is a generic product labeled by Laurus Labs Limited, priced at $0.4292 per EA under NDC 42385094601. Its NADAC has been published 242 times since Feb 16, 2022.
FDA first approved this application on Feb 12, 2020. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
300 mg/1
Manufacturer
Laurus Labs LimitedNDC
42385094601
Classification
Generic
Dosage Form
CAPSULE
Route
ORAL
Effective Date
9/23/2026
Active Ingredients
URSODIOLApproval Type
Generic (ANDA)
FDA Application
ANDA213200FDA Approved
2/12/2020
TE Code
AB
On Market Since
4/17/2021
Pharmacological Classes
Price Statistics
The NADAC for URSODIOL 300 MG CAPSULE has been published 242 times since Feb 16, 2022, and over the history we have for it it has declined 26.9%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.4292 per EA |
|---|---|
| All-time high | $0.6902 (Dec 14, 2022) |
| All-time low | $0.3666 (Jul 17, 2024) |
| 52-week high | $0.4811 |
| 52-week low | $0.4160 |
| Median price | $0.4836 |
| Average price | $0.5088 |
| Largest weekly change | +30.7% (Aug 21, 2024) |
| Weeks tracked | 242 |
| Tracking since | Feb 16, 2022 |
Generic Alternatives
The matcher finds 14 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 3% at current NADAC. These are candidates to verify clinically, not guaranteed substitutes — see our generic drug prices guide.
Related Drugs
Same classification
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Manufacturer
Laurus Labs Limited 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 300 MG CAPSULE?
The current National Average Drug Acquisition Cost (NADAC) for URSODIOL 300 MG CAPSULE, manufactured by Laurus Labs Limited, is $0.4292 per EA (NDC 42385094601), effective Sep 30, 2026.
How has the price of URSODIOL 300 MG CAPSULE changed over time?
Over the history we have for it, the NADAC for URSODIOL 300 MG CAPSULE has declined 26.9%. It has been tracked across 242 weekly CMS publications since Feb 16, 2022.
What are the highest and lowest recorded NADAC prices for URSODIOL 300 MG CAPSULE?
Since Feb 16, 2022, the NADAC for URSODIOL 300 MG CAPSULE has ranged from a low of $0.3666 (Jul 17, 2024) to a high of $0.6902 (Dec 14, 2022), with a median of $0.4836 per EA.
Are there cheaper alternatives to URSODIOL 300 MG CAPSULE?
Yes. 14 manufacturers publish a NADAC-priced product with the same active ingredient and strength in a comparable dosage form. The lowest-priced option, URSODIOL 300 MG CAPSULE, is $0.4160 per EA — about 3% below URSODIOL 300 MG CAPSULE.
Who manufactures URSODIOL 300 MG CAPSULE?
URSODIOL 300 MG CAPSULE (NDC 42385094601) is labeled by Laurus Labs Limited, and CMS classifies it as a generic product.