DrugDashboards

Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride · HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mL · Solution · Oral · Atlantic Biologicals Corp.

NDC 17856-0507-01 · 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 5 mL in 1 CUP, UNIT-DOSE · ANDA · View full market →

The short version

8 companies supply this market — a reasonable cushion if one runs into trouble.

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

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

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 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 →

Regulatory

Application
ANDA201674
TE code
AA
Approval date
Aug 21, 2013
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 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 17856-0507-01," retrieved September 3, 2026, https://drugdashboards.com/drug/17856050701.

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