The short version
7 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.
Mirtazapine
Mirtazapine · MIRTAZAPINE 30 mg/1 · Tablet, Orally Disintegrating · Oral · Square Pharmaceuticals Limited
NDC 76483-0111-00 · 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON · ANDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 57237-0012-06) — 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ⓘ
$0.6338per unit
middle half $0.4243–$0.8180 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.6338
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 2 · prior auth 0% · step therapy 0% · qty limit 48%
*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 mirtazapine (oral solid) 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 →
Where it's made
- Square Pharmaceuticals Plc.Bangladeshanalysis · label · manufacture · pack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA205798
- TE code
- AB
- Approval date
- Jun 1, 2017
- 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 Mirtazapine (Tablet, Orally Disintegrating)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aurobindo Pharma Limited | MIRTAZAPINE 15 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | MIRTAZAPINE 30 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Cardinal Health 107, LLC | MIRTAZAPINE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon LLC | MIRTAZAPINE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon LLC | MIRTAZAPINE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon LLC | MIRTAZAPINE 45 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Rising Pharma Holdings, Inc. | MIRTAZAPINE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Rising Pharma Holdings, Inc. | MIRTAZAPINE 45 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Rising Pharma Holdings, Inc. | MIRTAZAPINE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Square Pharmaceuticals Limited | MIRTAZAPINE 45 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Square Pharmaceuticals Limited | MIRTAZAPINE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Square Pharmaceuticals Limited | MIRTAZAPINE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Viona Pharmaceuticals Inc. | MIRTAZAPINE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Viona Pharmaceuticals Inc. | MIRTAZAPINE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Viona Pharmaceuticals Inc. | MIRTAZAPINE 45 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | MIRTAZAPINE 45 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Aurobindo Pharma Limited | MIRTAZAPINE 30 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, "Mirtazapine — NDC 76483-0111-00," retrieved September 3, 2026, https://drugdashboards.com/drug/76483011100.
Free to cite with attribution — see how the data is put together.