Product Information
ISOTRETINOIN 40 MG CAPSULE is a generic product labeled by Sun Pharmaceutical Industries Inc., priced at $6.7472 per EA under NDC 57664002597. Its NADAC has been published 275 times since May 19, 2021.
FDA first approved this application on May 25, 2012. Its Orange Book therapeutic-equivalence code is AB2 — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
The High Outlier badge above means this manufacturer's average price in the Isotretinoin market falls above Q3 + 1.5·IQR across all competing manufacturers. We only apply this flag in markets with four or more competitors. Full definition: glossary → outlier.
Strength
40 mg/1
Manufacturer
Sun Pharmaceutical Industries Inc.NDC
57664002597
Classification
Generic
Dosage Form
CAPSULE
Route
ORAL
Effective Date
8/19/2026
Active Ingredients
ISOTRETINOINApproval Type
Authorized Generic (NDA)
FDA Application
NDA021951FDA Approved
5/25/2012
TE Code
AB2
On Market Since
12/29/2020
Pharmacological Classes
Price Statistics
The NADAC for ISOTRETINOIN 40 MG CAPSULE has been published 275 times since May 19, 2021, and over the history we have for it it has risen 96.3%. The table below summarizes its recorded NADAC range and movement.
| Current price | $6.7472 per EA |
|---|---|
| All-time high | $26.7665 (Jun 15, 2022) |
| All-time low | $3.0414 (Jun 23, 2021) |
| 52-week high | $15.9249 |
| 52-week low | $5.0999 |
| Median price | $15.3368 |
| Average price | $16.4579 |
| Largest weekly change | +780.1% (Jul 21, 2021) |
| Weeks tracked | 275 |
| Tracking since | May 19, 2021 |
Generic Alternatives
The matcher finds 6 manufacturers 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). Switching to the cheapest would cut per-unit acquisition cost by roughly 68% at current NADAC. 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 ISOTRETINOIN 40 MG CAPSULE?
The current National Average Drug Acquisition Cost (NADAC) for ISOTRETINOIN 40 MG CAPSULE, manufactured by Sun Pharmaceutical Industries Inc., is $6.7472 per EA (NDC 57664002597), effective Aug 19, 2026.
How has the price of ISOTRETINOIN 40 MG CAPSULE changed over time?
Over the history we have for it, the NADAC for ISOTRETINOIN 40 MG CAPSULE has risen 96.3%. It has been tracked across 275 weekly CMS publications since May 19, 2021.
What are the highest and lowest recorded NADAC prices for ISOTRETINOIN 40 MG CAPSULE?
Since May 19, 2021, the NADAC for ISOTRETINOIN 40 MG CAPSULE has ranged from a low of $3.0414 (Jun 23, 2021) to a high of $26.7665 (Jun 15, 2022), with a median of $15.3368 per EA.
Are there cheaper alternatives to ISOTRETINOIN 40 MG CAPSULE?
Yes. 6 manufacturers publish a NADAC-priced product with the same active ingredient and strength in a comparable dosage form. The lowest-priced option, ISOTRETINOIN 40 MG CAPSULE, is $2.1849 per EA — about 68% below ISOTRETINOIN 40 MG CAPSULE.
Who manufactures ISOTRETINOIN 40 MG CAPSULE?
ISOTRETINOIN 40 MG CAPSULE (NDC 57664002597) is labeled by Sun Pharmaceutical Industries Inc., and CMS classifies it as a generic product.