Product Information

URSODIOL 500 MG TABLET is a generic product labeled by Strides Pharma Inc., priced at $0.6356 per EA under NDC 64380091906. Its NADAC has been published 280 times since Apr 14, 2021.

FDA first approved this application on Aug 20, 2020. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.

URSODIOL 500 MG TABLET

ursodiol
$0.6356per EA

Strength

500 mg/1

NDC

64380091906

Classification

Generic

Dosage Form

TABLET

Route

ORAL

Effective Date

8/19/2026

Active Ingredients

URSODIOL

Approval Type

Generic (ANDA)

FDA Application

ANDA213504

FDA Approved

8/20/2020

TE Code

AB

On Market Since

2/8/2021

Pharmacological Classes

Bile Acid
Bile Acids and Salts

Price Statistics

The NADAC for URSODIOL 500 MG TABLET has been published 280 times since Apr 14, 2021, and over the history we have for it it has declined 48.1%. The table below summarizes its recorded NADAC range and movement.

Current price$0.6356 per EA
All-time high$1.2239 (Apr 14, 2021)
All-time low$0.5191 (Jul 17, 2024)
52-week high$0.7862
52-week low$0.6355
Median price$0.8060
Average price$0.8342
Largest weekly change-33.1% (Jul 17, 2024)
Weeks tracked280
Tracking sinceApr 14, 2021

Price History

1W

-3.5%

1M

-3.5%

3M

-6.8%

6M

-3.7%

1Y

-19.2%

3Y

-23.4%

5Y

-38.9%

All

-48.1%

Generic Alternatives

No other NADAC-published product shares this drug's active ingredient and strength in a comparable dosage form. Compare the broader picture on the ursodiol market page.

Lowest-Cost Alternatives

No alternatives available

No alternatives found with the same active ingredient and strength in a comparable dosage form.

Frequently asked questions

What is the NADAC price of URSODIOL 500 MG TABLET?

The current National Average Drug Acquisition Cost (NADAC) for URSODIOL 500 MG TABLET, manufactured by Strides Pharma Inc., is $0.6356 per EA (NDC 64380091906), effective Aug 19, 2026.

How has the price of URSODIOL 500 MG TABLET changed over time?

Over the history we have for it, the NADAC for URSODIOL 500 MG TABLET has declined 48.1%. It has been tracked across 280 weekly CMS publications since Apr 14, 2021.

What are the highest and lowest recorded NADAC prices for URSODIOL 500 MG TABLET?

Since Apr 14, 2021, the NADAC for URSODIOL 500 MG TABLET has ranged from a low of $0.5191 (Jul 17, 2024) to a high of $1.2239 (Apr 14, 2021), with a median of $0.8060 per EA.

Are there cheaper alternatives to URSODIOL 500 MG TABLET?

No other NADAC-published product currently shares the active ingredient and strength of URSODIOL 500 MG TABLET in a comparable dosage form, so no direct lower-cost alternative is listed.

Who manufactures URSODIOL 500 MG TABLET?

URSODIOL 500 MG TABLET (NDC 64380091906) is labeled by Strides Pharma Inc., and CMS classifies it as a generic product.