Product Information
MESALAMINE 800 MG DR TABLET is a generic product labeled by Zydus Pharmaceuticals (USA) Inc., priced at $4.0205 per EA under NDC 68382043528. Its NADAC has been published 413 times since Nov 7, 2018.
FDA first approved this application on Jul 21, 2017. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
800 mg/1
Manufacturer
Zydus Pharmaceuticals (USA) Inc.NDC
68382043528
Classification
Generic
Dosage Form
TABLET, DELAYED RELEASE
Route
ORAL
Effective Date
9/23/2026
Active Ingredients
MESALAMINEApproval Type
Generic (ANDA)
FDA Application
ANDA203286FDA Approved
7/21/2017
TE Code
AB
On Market Since
8/2/2018
Pharmacological Classes
Price Statistics
The NADAC for MESALAMINE 800 MG DR TABLET has been published 413 times since Nov 7, 2018, and over the history we have for it it has declined 23.1%. The table below summarizes its recorded NADAC range and movement.
| Current price | $4.0205 per EA |
|---|---|
| All-time high | $6.6478 (Sep 11, 2019) |
| All-time low | $4.0027 (Aug 19, 2026) |
| 52-week high | $4.7363 |
| 52-week low | $4.0027 |
| Median price | $5.8207 |
| Average price | $5.6602 |
| Largest weekly change | +20.6% (Jul 19, 2023) |
| Weeks tracked | 413 |
| Tracking since | Nov 7, 2018 |
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 mesalamine market page.
Lowest-Cost Alternatives
No alternatives available
Related Drugs
Same classification
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Manufacturer
Zydus Pharmaceuticals (USA) Inc. manufacturer profile
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Drug market
mesalamine market comparison
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Therapeutic class
Aminosalicylate class view
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Trend hub
Latest market trends
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Guide
Understanding NADAC pricing
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Frequently asked questions
What is the NADAC price of MESALAMINE 800 MG DR TABLET?
The current National Average Drug Acquisition Cost (NADAC) for MESALAMINE 800 MG DR TABLET, manufactured by Zydus Pharmaceuticals (USA) Inc., is $4.0205 per EA (NDC 68382043528), effective Sep 30, 2026.
How has the price of MESALAMINE 800 MG DR TABLET changed over time?
Over the history we have for it, the NADAC for MESALAMINE 800 MG DR TABLET has declined 23.1%. It has been tracked across 413 weekly CMS publications since Nov 7, 2018.
What are the highest and lowest recorded NADAC prices for MESALAMINE 800 MG DR TABLET?
Since Nov 7, 2018, the NADAC for MESALAMINE 800 MG DR TABLET has ranged from a low of $4.0027 (Aug 19, 2026) to a high of $6.6478 (Sep 11, 2019), with a median of $5.8207 per EA.
Are there cheaper alternatives to MESALAMINE 800 MG DR TABLET?
No other NADAC-published product currently shares the active ingredient and strength of MESALAMINE 800 MG DR TABLET in a comparable dosage form, so no direct lower-cost alternative is listed.
Who manufactures MESALAMINE 800 MG DR TABLET?
MESALAMINE 800 MG DR TABLET (NDC 68382043528) is labeled by Zydus Pharmaceuticals (USA) Inc., and CMS classifies it as a generic product.