DrugDashboards

Hydrea

Hydroxyurea · HYDROXYUREA 500 mg/1 · Capsule · Oral · Waylis Therapeutics LLC

NDC 80725-0810-10 · 100 CAPSULE in 1 BOTTLE, PLASTIC · NDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Part D plans paid (avg)$1.25per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$9.16per unitnegotiated price across 2 plans — before rebates · Apr 1, 2026

Medicare Part D

All Part D pricing →
ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$9.16per unit
middle half $9.16$9.16 · 2 plans · Apr 1, 2026
Est. net of rebates
$5.50–$6.87
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
0%of plans cover it
tier 1 · prior auth 0% · step therapy 0% · qty limit 0%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 2 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for hydroxyurea (oral solid) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
NDA016295
TE code
AB
Approval date
Jan 1, 1982
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Hydroxyurea (Capsule)

LabelerStrengthFirst seenLast seen
American Health PackagingHYDROXYUREA 500 mg/1Jul 15, 2026Sep 2, 2026
AvKAREHYDROXYUREA 500 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCHYDROXYUREA 500 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.HYDROXYUREA 500 mg/1Jul 15, 2026Sep 2, 2026
H2-Pharma LLCHYDROXYUREA 200 mg/1Jul 15, 2026Sep 2, 2026
H2-Pharma LLCHYDROXYUREA 300 mg/1Jul 15, 2026Sep 2, 2026
H2-Pharma LLCHYDROXYUREA 400 mg/1Jul 15, 2026Sep 2, 2026
H2-Pharma LLCHYDROXYUREA 500 mg/1Jul 15, 2026Sep 2, 2026
Leading Pharma, LLCHYDROXYUREA 500 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsHYDROXYUREA 500 mg/1Jul 15, 2026Sep 2, 2026
Par Health USA, LLCHYDROXYUREA 500 mg/1Jul 15, 2026Sep 2, 2026
Qilu Pharmaceutical Co., Ltd.HYDROXYUREA 500 mg/1Jul 15, 2026Sep 2, 2026
Somerset Therapeutics, LLCHYDROXYUREA 500 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.HYDROXYUREA 500 mg/1Jul 15, 2026Sep 2, 2026
Waylis Therapeutics LLCHYDROXYUREA 400 mg/1Jul 15, 2026Sep 2, 2026
Waylis Therapeutics LLCHYDROXYUREA 200 mg/1Jul 15, 2026Sep 2, 2026
Waylis Therapeutics LLCHYDROXYUREA 500 mg/1Jul 15, 2026Sep 2, 2026
Waylis Therapeutics LLCHYDROXYUREA 300 mg/1Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Hydrea — NDC 80725-0810-10," retrieved September 3, 2026, https://drugdashboards.com/drug/80725081010.

Free to cite with attribution — see how the data is put together.