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Product Information

AMNESTEEM 10 MG CAPSULE is a generic product labeled by Mylan Pharmaceuticals Inc., priced at $1.8768 per EA under NDC 00378661193. Its NADAC has been published 624 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.

AMNESTEEM 10 MG CAPSULE

isotretinoin
$1.8768per EA

Strength

10 mg/1

NDC

00378661193

Classification

Generic

Dosage Form

CAPSULE

Route

ORAL

Effective Date

8/19/2026

Active Ingredients

ISOTRETINOIN

Approval Type

Generic (ANDA)

FDA Application

ANDA075945

FDA Approved

11/8/2002

TE Code

AB1

On Market Since

11/11/2002

Pharmacological Classes

Retinoid
Retinoids

Price Statistics

The NADAC for AMNESTEEM 10 MG CAPSULE has been published 624 times since Nov 28, 2013, and over the history we have for it it has declined 72.5%. The table below summarizes its recorded NADAC range and movement.

Current price$1.8768 per EA
All-time high$7.2608 (Mar 11, 2015)
All-time low$1.3264 (Aug 21, 2024)
52-week high$2.2921
52-week low$1.6125
Median price$2.9343
Average price$3.7122
Largest weekly change-40.2% (Mar 22, 2023)
Weeks tracked624
Tracking sinceNov 28, 2013

Price History

1W

+13.5%

1M

+13.5%

3M

+16.0%

6M

+6.9%

1Y

-18.1%

3Y

-2.2%

5Y

-40.8%

All

-72.5%

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

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

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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 $1.8768 per EA (NDC 00378661193), effective Aug 19, 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 72.5%. It has been tracked across 624 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 $2.9343 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.