Product Information
HYDROXYUREA 500 MG CAPSULE is a generic product labeled by Major Pharmaceuticals, priced at $0.1836 per EA under NDC 00904693961. Its NADAC has been published 380 times since Jun 26, 2019.
FDA first approved this application on Feb 24, 1999. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
500 mg/1
Manufacturer
Major PharmaceuticalsNDC
00904693961
Classification
Generic
Dosage Form
CAPSULE
Route
ORAL
Effective Date
9/23/2026
Active Ingredients
HYDROXYUREAApproval Type
Generic (ANDA)
FDA Application
ANDA075340FDA Approved
2/24/1999
TE Code
AB
On Market Since
2/24/1999
Pharmacological Classes
Price Statistics
The NADAC for HYDROXYUREA 500 MG CAPSULE has been published 380 times since Jun 26, 2019, and over the history we have for it it has declined 42.4%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.1836 per EA |
|---|---|
| All-time high | $0.3191 (Jul 10, 2019) |
| All-time low | $0.1836 (Sep 23, 2026) |
| 52-week high | $0.2041 |
| 52-week low | $0.1836 |
| Median price | $0.2565 |
| Average price | $0.2526 |
| Largest weekly change | +17.3% (Aug 21, 2024) |
| Weeks tracked | 380 |
| Tracking since | Jun 26, 2019 |
Generic Alternatives
The matcher finds 3 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
Continue researching this drug
Use these direct paths to move from a single NDC into the surrounding market, manufacturer, class, and trend context.
Manufacturer
Major Pharmaceuticals manufacturer profile
See the full portfolio, pricing trend, and other products from this labeler.
Drug market
Hydroxyurea market comparison
Compare this molecule across participating manufacturers and inspect the broader market price spread.
Therapeutic class
Antimetabolite class view
See how this drug behaves alongside other products in the same FDA pharmacologic class.
Trend hub
Latest market trends
Zoom back out to the weekly mover view and compare this NDC with the rest of the current NADAC release.
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 HYDROXYUREA 500 MG CAPSULE?
The current National Average Drug Acquisition Cost (NADAC) for HYDROXYUREA 500 MG CAPSULE, manufactured by Major Pharmaceuticals, is $0.1836 per EA (NDC 00904693961), effective Sep 30, 2026.
How has the price of HYDROXYUREA 500 MG CAPSULE changed over time?
Over the history we have for it, the NADAC for HYDROXYUREA 500 MG CAPSULE has declined 42.4%. It has been tracked across 380 weekly CMS publications since Jun 26, 2019.
What are the highest and lowest recorded NADAC prices for HYDROXYUREA 500 MG CAPSULE?
Since Jun 26, 2019, the NADAC for HYDROXYUREA 500 MG CAPSULE has ranged from a low of $0.1836 (Sep 23, 2026) to a high of $0.3191 (Jul 10, 2019), with a median of $0.2565 per EA.
Are there cheaper alternatives to HYDROXYUREA 500 MG CAPSULE?
3 manufacturers publish a NADAC-priced product with the same active ingredient and strength as HYDROXYUREA 500 MG CAPSULE in a comparable dosage form, but none are currently priced below it.
Who manufactures HYDROXYUREA 500 MG CAPSULE?
HYDROXYUREA 500 MG CAPSULE (NDC 00904693961) is labeled by Major Pharmaceuticals, and CMS classifies it as a generic product.