DrugDashboards

Clozapine

Clozapine · CLOZAPINE 100 mg/1 · Tablet · Oral · Aurobindo Pharma Limited

NDC 65862-0846-78 · 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK · ANDA · View full market →

The short version

10 companies supply this market — deep enough that no single failure threatens the supply.

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 65862-0846-05) — 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
$0.8589per unit
middle half $0.6337$1.15 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $0.8589
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 3 · prior auth 20% · step therapy 0% · qty limit 58%

*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 clozapine (oral solid) in the next 90 days

sole-source market · price up 2% 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
ANDA206433
TE code
AB
Approval date
Nov 29, 2016
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedJun 12, 2020
    Aurobindo Pharma USA Inc.Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.

Manufacturers of Clozapine (Tablet)

LabelerStrengthFirst seenLast seen
Aurobindo Pharma LimitedCLOZAPINE 200 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedCLOZAPINE 50 mg/1Jul 15, 2026Sep 3, 2026
Accord Healthcare Inc.CLOZAPINE 25 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare Inc.CLOZAPINE 100 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingCLOZAPINE 25 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingCLOZAPINE 200 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingCLOZAPINE 50 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingCLOZAPINE 100 mg/1Jul 15, 2026Sep 2, 2026
Cardinal Health 107, LLCCLOZAPINE 100 mg/1Jul 15, 2026Sep 2, 2026
HLS Therapeutics (USA), Inc.CLOZAPINE 25 mg/1Jul 15, 2026Sep 2, 2026
HLS Therapeutics (USA), Inc.CLOZAPINE 100 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsCLOZAPINE 25 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsCLOZAPINE 200 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsCLOZAPINE 50 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsCLOZAPINE 100 mg/1Jul 15, 2026Sep 2, 2026
Mylan Institutional Inc.CLOZAPINE 100 mg/1Jul 15, 2026Sep 2, 2026
Mylan Institutional Inc.CLOZAPINE 200 mg/1Jul 15, 2026Sep 2, 2026
Mylan Institutional Inc.CLOZAPINE 25 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.CLOZAPINE 200 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.CLOZAPINE 50 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.CLOZAPINE 100 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.CLOZAPINE 25 mg/1Jul 15, 2026Sep 2, 2026
NorthStar Rx LLCCLOZAPINE 50 mg/1Aug 5, 2026Sep 2, 2026
NorthStar Rx LLCCLOZAPINE 100 mg/1Aug 5, 2026Sep 2, 2026
NorthStar Rx LLCCLOZAPINE 200 mg/1Aug 5, 2026Sep 2, 2026
NorthStar Rx LLCCLOZAPINE 25 mg/1Aug 5, 2026Sep 2, 2026
Safecor Health LLCCLOZAPINE 25 mg/1Jul 15, 2026Sep 2, 2026
Safecor Health LLCCLOZAPINE 200 mg/1Jul 15, 2026Sep 2, 2026
Safecor Health LLCCLOZAPINE 100 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedCLOZAPINE 25 mg/1Jul 15, 2026Aug 31, 2026
Aurobindo Pharma LimitedCLOZAPINE 100 mg/1Jul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Clozapine — NDC 65862-0846-78," retrieved September 3, 2026, https://drugdashboards.com/drug/65862084678.

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