Product Information
AMNESTEEM 10 MG CAPSULE is a generic product labeled by Mylan Pharmaceuticals Inc., priced at $1.9631 per EA under NDC 00378661193. Its NADAC has been published 630 times since Nov 28, 2013.
FDA first approved this application on Nov 8, 2002. Its Orange Book therapeutic-equivalence code is AB1 — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
10 mg/1
Manufacturer
Mylan Pharmaceuticals Inc.NDC
00378661193
Classification
Generic
Dosage Form
CAPSULE
Route
ORAL
Effective Date
9/23/2026
Active Ingredients
ISOTRETINOINApproval Type
Generic (ANDA)
FDA Application
ANDA075945FDA Approved
11/8/2002
TE Code
AB1
On Market Since
11/11/2002
Pharmacological Classes
Price Statistics
The NADAC for AMNESTEEM 10 MG CAPSULE has been published 630 times since Nov 28, 2013, and over the history we have for it it has declined 71.2%. The table below summarizes its recorded NADAC range and movement.
| Current price | $1.9631 per EA |
|---|---|
| All-time high | $7.2608 (Mar 11, 2015) |
| All-time low | $1.3264 (Aug 21, 2024) |
| 52-week high | $2.1914 |
| 52-week low | $1.6125 |
| Median price | $2.9110 |
| Average price | $3.6950 |
| Largest weekly change | -40.2% (Mar 22, 2023) |
| Weeks tracked | 630 |
| Tracking since | Nov 28, 2013 |
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 isotretinoin market page.
Lowest-Cost Alternatives
No alternatives available
Related Drugs
Same classification
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Manufacturer
Mylan Pharmaceuticals Inc. manufacturer profile
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Drug market
isotretinoin market comparison
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Therapeutic class
Retinoid class view
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Trend hub
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Guide
Understanding NADAC pricing
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Frequently asked questions
What is the NADAC price of AMNESTEEM 10 MG CAPSULE?
The current National Average Drug Acquisition Cost (NADAC) for AMNESTEEM 10 MG CAPSULE, manufactured by Mylan Pharmaceuticals Inc., is $1.9631 per EA (NDC 00378661193), effective Sep 30, 2026.
How has the price of AMNESTEEM 10 MG CAPSULE changed over time?
Over the history we have for it, the NADAC for AMNESTEEM 10 MG CAPSULE has declined 71.2%. It has been tracked across 630 weekly CMS publications since Nov 28, 2013.
What are the highest and lowest recorded NADAC prices for AMNESTEEM 10 MG CAPSULE?
Since Nov 28, 2013, the NADAC for AMNESTEEM 10 MG CAPSULE has ranged from a low of $1.3264 (Aug 21, 2024) to a high of $7.2608 (Mar 11, 2015), with a median of $2.9110 per EA.
Are there cheaper alternatives to AMNESTEEM 10 MG CAPSULE?
No other NADAC-published product currently shares the active ingredient and strength of AMNESTEEM 10 MG CAPSULE in a comparable dosage form, so no direct lower-cost alternative is listed.
Who manufactures AMNESTEEM 10 MG CAPSULE?
AMNESTEEM 10 MG CAPSULE (NDC 00378661193) is labeled by Mylan Pharmaceuticals Inc., and CMS classifies it as a generic product.