DrugDashboards

Cetirizine Hydrochloride Oral Solution

Cetirizine Hydrochloride Oral Solution · CETIRIZINE HYDROCHLORIDE 1 mg/mL · Solution · Oral · Apozeal Pharmaceuticals Inc

NDC 83745-0185-08 · 240 mL in 1 BOTTLE · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Apozeal Pharmaceuticals Inc, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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

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.

Estimated fill cost

WAC per package, as filed
$20.36
Reported to Texas DSHS · 2026 annual filing · Apozeal Pharmaceuticals Inc

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicaid spend (2026 YTD · Q1)

$134
19 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

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

90-day shortage risk (model v2)

0.2%chance of a new FDA shortage posting for cetirizine hydrochloride (other) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market · price up 5% YoY

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
ANDA078870
TE code
AA
Approval date
Apr 27, 2009
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 Cetirizine Hydrochloride Oral Solution (Solution)

LabelerStrengthFirst seenLast seen
Apozeal Pharmaceuticals IncCETIRIZINE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Chartwell RX, LLCCETIRIZINE HYDROCHLORIDE 5 mg/5mLJul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals Inc.CETIRIZINE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Cetirizine Hydrochloride Oral Solution — NDC 83745-0185-08," retrieved September 3, 2026, https://drugdashboards.com/drug/83745018508.

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