Clozapine
Clozapine · CLOZAPINE 50 mg/1 · Tablet · Aurobindo Pharma Limited
NDC 65862-0845-59 · 5000 TABLET in 1 BAG · DRUG FOR FURTHER PROCESSING · View full market →
Bulk ingredient — not a finished product
This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 65862-0845-01) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
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.
*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)
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
- analysis · manufacture
- analysis · manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- —
- TE code
- —
- Approval date
- —
- Patents / exclusivity
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Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Clozapine (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aurobindo Pharma Limited | CLOZAPINE 200 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Aurobindo Pharma Limited | CLOZAPINE 50 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Accord Healthcare Inc. | CLOZAPINE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Accord Healthcare Inc. | CLOZAPINE 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| American Health Packaging | CLOZAPINE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| American Health Packaging | CLOZAPINE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| American Health Packaging | CLOZAPINE 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| American Health Packaging | CLOZAPINE 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Cardinal Health 107, LLC | CLOZAPINE 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| HLS Therapeutics (USA), Inc. | CLOZAPINE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| HLS Therapeutics (USA), Inc. | CLOZAPINE 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Major Pharmaceuticals | CLOZAPINE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Major Pharmaceuticals | CLOZAPINE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Major Pharmaceuticals | CLOZAPINE 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Major Pharmaceuticals | CLOZAPINE 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Institutional Inc. | CLOZAPINE 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Institutional Inc. | CLOZAPINE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Institutional Inc. | CLOZAPINE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | CLOZAPINE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | CLOZAPINE 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | CLOZAPINE 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | CLOZAPINE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| NorthStar Rx LLC | CLOZAPINE 50 mg/1 | Aug 5, 2026 | Sep 2, 2026 |
| NorthStar Rx LLC | CLOZAPINE 100 mg/1 | Aug 5, 2026 | Sep 2, 2026 |
| NorthStar Rx LLC | CLOZAPINE 200 mg/1 | Aug 5, 2026 | Sep 2, 2026 |
| NorthStar Rx LLC | CLOZAPINE 25 mg/1 | Aug 5, 2026 | Sep 2, 2026 |
| Safecor Health LLC | CLOZAPINE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Safecor Health LLC | CLOZAPINE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Safecor Health LLC | CLOZAPINE 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | CLOZAPINE 25 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Aurobindo Pharma Limited | CLOZAPINE 100 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Clozapine — NDC 65862-0845-59," retrieved September 3, 2026, https://drugdashboards.com/drug/65862084559.
Free to cite with attribution — see how the data is put together.