DrugDashboards

Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride · HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mL · Solution · Oral · ANI Pharmaceuticals, Inc.

NDC 70954-0912-10 · 473 mL in 1 BOTTLE · ANDA · View full market →

The short version

8 companies supply this market — a reasonable cushion if one runs into trouble. 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)$0.1089per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicaid generic ceiling (FUL)$0.1089per MLweighted avg manufacturer price $0.0527 · 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 54838-0502-80) — 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
$0.1507per unit
middle half $0.1407$0.1790 · 3,240 plans · Apr 1, 2026
Est. net of rebates
≈ $0.1507
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
59%of plans cover it
tier 4 · prior auth 85% · 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$0.05$0.1$0.15Mar 2026Sep 2026$0.1089
6 price points · per ML · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Medicaid spend (2026 YTD · Q1)

$4,365
87 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 hydroxyzine hydrochloride (other) 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
ANDA219648
TE code
AA
Approval date
Dec 16, 2025
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · OngoingJun 2, 2026
    ANI Pharmaceuticals, Inc.Presence of foreign substance

Manufacturers of Hydroxyzine Hydrochloride (Solution)

LabelerStrengthFirst seenLast seen
ANI Pharmaceuticals, Inc.HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mLJul 15, 2026Sep 2, 2026
Apozeal Pharmaceuticals IncHYDROXYZINE HYDROCHLORIDE 10 mg/5mLJul 22, 2026Sep 2, 2026
Atlantic Biologicals Corp.HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mLJul 15, 2026Sep 2, 2026
Chartwell RX, LLCHYDROXYZINE DIHYDROCHLORIDE 10 mg/5mLJul 15, 2026Sep 2, 2026
Kesin PharmaHYDROXYZINE DIHYDROCHLORIDE 10 mg/5mLJul 15, 2026Sep 2, 2026
Lannett Company, Inc.HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mLJul 15, 2026Sep 2, 2026
PAI Holdings, LLC dba PAI PharmaHYDROXYZINE DIHYDROCHLORIDE 10 mg/5mLJul 15, 2026Sep 2, 2026
Saptalis Pharmaceuticals, LLC.HYDROXYZINE HYDROCHLORIDE 10 mg/5mLJul 15, 2026Sep 2, 2026
Apozeal Pharmaceuticals IncHYDROXYZINE DIHYDROCHLORIDE 10 mg/5mLJul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Hydroxyzine Hydrochloride — NDC 70954-0912-10," retrieved September 3, 2026, https://drugdashboards.com/drug/70954091210.

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