DrugDashboards

Hydroxyurea

Hydroxyurea · HYDROXYUREA 500 mg/1 · Capsule · Oral · Leading Pharma, LLC

NDC 69315-0164-01 · 100 CAPSULE in 1 BOTTLE, PLASTIC · ANDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply. The price is down 9% over the past year, to $0.1868 per unit. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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.

  • Pharmacies pay (NADAC)$0.1868per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$0.2853per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$0.1868per CAPweighted avg manufacturer price $0.0890 · Aug 1, 2026100% of what pharmacies pay — higher than 10% of drugs with this benchmark

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 49884-0724-01) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ 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
$0.3082per unit
middle half $0.2367$0.4211 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $0.3082
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 2 · 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 10 quarters since 2024.

NADAC price per unit

$0$0.1$0.2$0.3Jun 2022Sep 2026$0.1868
51 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$5.60
#90 count
$16.81

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$237,696
8,562 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

0Low risk

Nothing here is signaling trouble: several manufacturers, no current shortage, no recent serious recalls, stable pricing. In drug supply, boring is the good outcome.

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

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
ANDA213438
TE code
AB
Approval date
Apr 8, 2020
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, "Hydroxyurea — NDC 69315-0164-01," retrieved September 3, 2026, https://drugdashboards.com/drug/69315016401.

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