Product Information
ROFLUMILAST 500 MCG TABLET is a generic product labeled by Major Pharmaceuticals, priced at $0.3113 per EA under NDC 00904748389. Its NADAC has been published 70 times since Jun 4, 2025.
FDA first approved this application on Sep 7, 2022. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
500 ug/1
Manufacturer
Major PharmaceuticalsNDC
00904748389
Classification
Generic
Dosage Form
TABLET
Route
ORAL
Effective Date
9/23/2026
Active Ingredients
ROFLUMILASTApproval Type
Generic (ANDA)
FDA Application
ANDA208256FDA Approved
9/7/2022
TE Code
AB
On Market Since
5/22/2024
Pharmacological Classes
Price Statistics
The NADAC for ROFLUMILAST 500 MCG TABLET has been published 70 times since Jun 4, 2025, and over the history we have for it it has declined 10.8%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.3113 per EA |
|---|---|
| All-time high | $0.3654 (Jul 16, 2025) |
| All-time low | $0.3113 (Sep 23, 2026) |
| 52-week high | $0.3445 |
| 52-week low | $0.3113 |
| Median price | $0.3213 |
| Average price | $0.3290 |
| Largest weekly change | -8.9% (Sep 17, 2025) |
| Weeks tracked | 70 |
| Tracking since | Jun 4, 2025 |
Generic Alternatives
The matcher finds 7 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). 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
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Manufacturer
Major Pharmaceuticals manufacturer profile
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Drug market
Roflumilast market comparison
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Therapeutic class
Phosphodiesterase 4 Inhibitor class view
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Trend hub
Latest market trends
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Guide
Understanding NADAC pricing
Use the explainer when you need context on how CMS publishes NADAC and how to interpret the number on this page.
Frequently asked questions
What is the NADAC price of ROFLUMILAST 500 MCG TABLET?
The current National Average Drug Acquisition Cost (NADAC) for ROFLUMILAST 500 MCG TABLET, manufactured by Major Pharmaceuticals, is $0.3113 per EA (NDC 00904748389), effective Sep 30, 2026.
How has the price of ROFLUMILAST 500 MCG TABLET changed over time?
Over the history we have for it, the NADAC for ROFLUMILAST 500 MCG TABLET has declined 10.8%. It has been tracked across 70 weekly CMS publications since Jun 4, 2025.
What are the highest and lowest recorded NADAC prices for ROFLUMILAST 500 MCG TABLET?
Since Jun 4, 2025, the NADAC for ROFLUMILAST 500 MCG TABLET has ranged from a low of $0.3113 (Sep 23, 2026) to a high of $0.3654 (Jul 16, 2025), with a median of $0.3213 per EA.
Are there cheaper alternatives to ROFLUMILAST 500 MCG TABLET?
7 manufacturers publish a NADAC-priced product with the same active ingredient and strength as ROFLUMILAST 500 MCG TABLET in a comparable dosage form, but none are currently priced below it.
Who manufactures ROFLUMILAST 500 MCG TABLET?
ROFLUMILAST 500 MCG TABLET (NDC 00904748389) is labeled by Major Pharmaceuticals, and CMS classifies it as a generic product.