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.
Hydroxyzine Hydrochloride
Hydroxyzine Hydrochloride · HYDROXYZINE HYDROCHLORIDE 10 mg/5mL · Solution · Oral · Saptalis Pharmaceuticals, LLC.
NDC 71656-0090-16 · 473 mL in 1 BOTTLE · ANDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →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
- ANDA220271
- TE code
- AA
- Approval date
- Jun 11, 2026
- 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)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| ANI Pharmaceuticals, Inc. | HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Apozeal Pharmaceuticals Inc | HYDROXYZINE HYDROCHLORIDE 10 mg/5mL | Jul 22, 2026 | Sep 2, 2026 |
| Atlantic Biologicals Corp. | HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Chartwell RX, LLC | HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Kesin Pharma | HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Lannett Company, Inc. | HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| PAI Holdings, LLC dba PAI Pharma | HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Saptalis Pharmaceuticals, LLC. | HYDROXYZINE HYDROCHLORIDE 10 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Apozeal Pharmaceuticals Inc | HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mL | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Hydroxyzine Hydrochloride — NDC 71656-0090-16," retrieved September 3, 2026, https://drugdashboards.com/drug/71656009016.
Free to cite with attribution — see how the data is put together.