Product Information
HYDROXYUREA 500 MG CAPSULE is a generic product labeled by Leading Pharma, LLC, priced at $0.1868 per EA under NDC 69315016401. Its NADAC has been published 221 times since Jun 1, 2022.
FDA first approved this application on Apr 8, 2020. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
500 mg/1
Manufacturer
Leading Pharma, LLCNDC
69315016401
Classification
Generic
Dosage Form
CAPSULE
Route
ORAL
Effective Date
8/19/2026
Active Ingredients
HYDROXYUREAApproval Type
Generic (ANDA)
FDA Application
ANDA213438FDA Approved
4/8/2020
TE Code
AB
On Market Since
7/9/2020
Pharmacological Classes
Price Statistics
The NADAC for HYDROXYUREA 500 MG CAPSULE has been published 221 times since Jun 1, 2022, and over the history we have for it it has declined 35.8%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.1868 per EA |
|---|---|
| All-time high | $0.2909 (Jun 15, 2022) |
| All-time low | $0.1868 (Aug 19, 2026) |
| 52-week high | $0.2041 |
| 52-week low | $0.1868 |
| Median price | $0.2241 |
| Average price | $0.2280 |
| Largest weekly change | +17.3% (Aug 21, 2024) |
| Weeks tracked | 221 |
| Tracking since | Jun 1, 2022 |
Generic Alternatives
The matcher finds 1 manufacturer 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
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 Leading Pharma, LLC, is $0.1868 per EA (NDC 69315016401), effective Aug 19, 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 35.8%. It has been tracked across 221 weekly CMS publications since Jun 1, 2022.
What are the highest and lowest recorded NADAC prices for HYDROXYUREA 500 MG CAPSULE?
Since Jun 1, 2022, the NADAC for HYDROXYUREA 500 MG CAPSULE has ranged from a low of $0.1868 (Aug 19, 2026) to a high of $0.2909 (Jun 15, 2022), with a median of $0.2241 per EA.
Are there cheaper alternatives to HYDROXYUREA 500 MG CAPSULE?
1 manufacturer publishes 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 69315016401) is labeled by Leading Pharma, LLC, and CMS classifies it as a generic product.