Product Information
AMNESTEEM 40 MG CAPSULE is a generic product labeled by Mylan Pharmaceuticals Inc., priced at $2.1849 per EA under NDC 00378661493. Its NADAC has been published 645 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
40 mg/1
Manufacturer
Mylan Pharmaceuticals Inc.NDC
00378661493
Classification
Generic
Dosage Form
CAPSULE
Route
ORAL
Effective Date
8/19/2026
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 40 MG CAPSULE has been published 645 times since Nov 28, 2013, and over the history we have for it it has declined 70.1%. The table below summarizes its recorded NADAC range and movement.
| Current price | $2.1849 per EA |
|---|---|
| All-time high | $7.7744 (Jun 11, 2014) |
| All-time low | $1.9456 (Nov 20, 2024) |
| 52-week high | $2.4672 |
| 52-week low | $2.0775 |
| Median price | $3.2020 |
| Average price | $4.1218 |
| Largest weekly change | +28.0% (Aug 21, 2024) |
| Weeks tracked | 645 |
| Tracking since | Nov 28, 2013 |
Generic Alternatives
The matcher finds 1 manufacturer 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). None of the shown alternatives sit below the current price. These are candidates to verify clinically, not guaranteed substitutes — see our generic drug prices guide.
Related Drugs
Same classification
Frequently asked questions
What is the NADAC price of AMNESTEEM 40 MG CAPSULE?
The current National Average Drug Acquisition Cost (NADAC) for AMNESTEEM 40 MG CAPSULE, manufactured by Mylan Pharmaceuticals Inc., is $2.1849 per EA (NDC 00378661493), effective Aug 19, 2026.
How has the price of AMNESTEEM 40 MG CAPSULE changed over time?
Over the history we have for it, the NADAC for AMNESTEEM 40 MG CAPSULE has declined 70.1%. It has been tracked across 645 weekly CMS publications since Nov 28, 2013.
What are the highest and lowest recorded NADAC prices for AMNESTEEM 40 MG CAPSULE?
Since Nov 28, 2013, the NADAC for AMNESTEEM 40 MG CAPSULE has ranged from a low of $1.9456 (Nov 20, 2024) to a high of $7.7744 (Jun 11, 2014), with a median of $3.2020 per EA.
Are there cheaper alternatives to AMNESTEEM 40 MG CAPSULE?
1 manufacturer publishes a NADAC-priced product with the same active ingredient and strength as AMNESTEEM 40 MG CAPSULE in a comparable dosage form, but none are currently priced below it.
Who manufactures AMNESTEEM 40 MG CAPSULE?
AMNESTEEM 40 MG CAPSULE (NDC 00378661493) is labeled by Mylan Pharmaceuticals Inc., and CMS classifies it as a generic product.