DrugDashboards

Quetiapine

quetiapine · QUETIAPINE 50 mg/1 · Tablet, Extended Release · Oral · Solco Healthcare U.S., LLC

NDC 43547-0019-06 · 60 TABLET, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

9 companies supply this market — a reasonable cushion if one runs into trouble. One of its named manufacturing plants, Zhejiang Huahai Pharmaceutical Co., Ltd., 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.

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 quetiapine (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · 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
ANDA208781
TE code
AB
Approval date
Apr 26, 2022
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 quetiapine (Tablet, Extended Release)

LabelerStrengthFirst seenLast seen
AstraZeneca Pharmaceuticals LPQUETIAPINE FUMARATE 150 mg/1Jul 15, 2026Sep 3, 2026
AstraZeneca Pharmaceuticals LPQUETIAPINE FUMARATE 200 mg/1Jul 15, 2026Sep 3, 2026
AstraZeneca Pharmaceuticals LPQUETIAPINE FUMARATE 400 mg/1Jul 15, 2026Sep 3, 2026
AstraZeneca Pharmaceuticals LPQUETIAPINE FUMARATE 300 mg/1Jul 15, 2026Sep 3, 2026
AstraZeneca Pharmaceuticals LPQUETIAPINE FUMARATE 50 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesQUETIAPINE FUMARATE 300 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesQUETIAPINE FUMARATE 150 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesQUETIAPINE FUMARATE 400 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesQUETIAPINE FUMARATE 50 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesQUETIAPINE FUMARATE 200 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCQUETIAPINE FUMARATE 200 mg/1Jul 15, 2026Sep 2, 2026
H2-Pharma, LLCQUETIAPINE FUMARATE 50 mg/1Jul 15, 2026Sep 2, 2026
H2-Pharma, LLCQUETIAPINE FUMARATE 400 mg/1Jul 15, 2026Sep 2, 2026
H2-Pharma, LLCQUETIAPINE FUMARATE 150 mg/1Jul 15, 2026Sep 2, 2026
H2-Pharma, LLCQUETIAPINE FUMARATE 200 mg/1Jul 15, 2026Sep 2, 2026
H2-Pharma, LLCQUETIAPINE FUMARATE 300 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedQUETIAPINE FUMARATE 150 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedQUETIAPINE FUMARATE 400 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedQUETIAPINE FUMARATE 300 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedQUETIAPINE FUMARATE 200 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.QUETIAPINE FUMARATE 50 mg/1Jul 15, 2026Sep 2, 2026
Solco Healthcare U.S., LLCQUETIAPINE 150 mg/1Jul 15, 2026Sep 2, 2026
Solco Healthcare U.S., LLCQUETIAPINE 200 mg/1Jul 15, 2026Sep 2, 2026
Solco Healthcare U.S., LLCQUETIAPINE 300 mg/1Jul 15, 2026Sep 2, 2026
Solco Healthcare U.S., LLCQUETIAPINE 400 mg/1Jul 15, 2026Sep 2, 2026
Solco Healthcare U.S., LLCQUETIAPINE 50 mg/1Jul 15, 2026Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.QUETIAPINE FUMARATE 50 mg/1Jul 15, 2026Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.QUETIAPINE FUMARATE 200 mg/1Jul 15, 2026Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.QUETIAPINE FUMARATE 150 mg/1Jul 15, 2026Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.QUETIAPINE FUMARATE 400 mg/1Jul 15, 2026Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.QUETIAPINE FUMARATE 300 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackQUETIAPINE FUMARATE 400 mg/1Jul 15, 2026Aug 31, 2026
Remedyrepack Inc.QUETIAPINE FUMARATE 200 mg/1Jul 18, 2026Aug 29, 2026
Remedyrepack Inc.QUETIAPINE FUMARATE 400 mg/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Quetiapine — NDC 43547-0019-06," retrieved September 3, 2026, https://drugdashboards.com/drug/43547001906.

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