Product Information
ROFLUMILAST 500 MCG TABLET is a generic product labeled by Major Pharmaceuticals, priced at $0.3204 per EA under NDC 00904739989. Its NADAC has been published 124 times since Feb 21, 2024.
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
00904739989
Classification
Generic
Dosage Form
TABLET
Route
ORAL
Effective Date
6/17/2026
Active Ingredients
ROFLUMILASTApproval Type
Generic (ANDA)
FDA Application
ANDA208256FDA Approved
9/7/2022
TE Code
AB
On Market Since
12/26/2023
Pharmacological Classes
Price Statistics
The NADAC for ROFLUMILAST 500 MCG TABLET has been published 124 times since Feb 21, 2024, and over the history we have for it it has declined 20.8%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.3204 per EA |
|---|---|
| All-time high | $0.4359 (Apr 10, 2024) |
| All-time low | $0.2563 (Nov 20, 2024) |
| 52-week high | $0.3458 |
| 52-week low | $0.3118 |
| Median price | $0.3364 |
| Average price | $0.3429 |
| Largest weekly change | +40.4% (Jun 19, 2024) |
| Weeks tracked | 124 |
| Tracking since | Feb 21, 2024 |
1W
N/A
1M
N/A
3M
-0.3%
6M
-1.8%
1Y
-7.3%
3Y
N/A
5Y
N/A
All
-20.8%
Last surveyed Jul 1, 2026 — this NDC no longer appears in the current weekly NADAC file.
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). Switching to the cheapest would cut per-unit acquisition cost by roughly 1% 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 ROFLUMILAST 500 MCG TABLET?
The current National Average Drug Acquisition Cost (NADAC) for ROFLUMILAST 500 MCG TABLET, manufactured by Major Pharmaceuticals, is $0.3204 per EA (NDC 00904739989), effective Jul 1, 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 20.8%. It has been tracked across 124 weekly CMS publications since Feb 21, 2024.
What are the highest and lowest recorded NADAC prices for ROFLUMILAST 500 MCG TABLET?
Since Feb 21, 2024, the NADAC for ROFLUMILAST 500 MCG TABLET has ranged from a low of $0.2563 (Nov 20, 2024) to a high of $0.4359 (Apr 10, 2024), with a median of $0.3364 per EA.
Are there cheaper alternatives to ROFLUMILAST 500 MCG TABLET?
Yes. 7 manufacturers publish a NADAC-priced product with the same active ingredient and strength in a comparable dosage form. The lowest-priced option, ROFLUMILAST 500 MCG TABLET, is $0.3160 per EA — about 1% below ROFLUMILAST 500 MCG TABLET.
Who manufactures ROFLUMILAST 500 MCG TABLET?
ROFLUMILAST 500 MCG TABLET (NDC 00904739989) is labeled by Major Pharmaceuticals, and CMS classifies it as a generic product.