DrugDashboards

Mirtazapine

Mirtazapine · MIRTAZAPINE 30 mg/1 · Tablet, Film Coated · Oral · Aurolife Pharma LLC

NDC 13107-0003-01 · 100 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

19 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 13107-0003-34) — 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
$0.1865per unit
middle half $0.1271$0.2819 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $0.1865
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 2 · prior auth 0% · step therapy 0% · qty limit 20%

*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

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA076921
TE code
AB
Approval date
Oct 22, 2004
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedMar 18, 2020
    Aurobindo Pharma USA Inc.CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
  • Class I · TerminatedNov 20, 2019
    AuroMedics Pharma LLCLabeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
  • Class I · TerminatedNov 20, 2019
    AuroMedics Pharma LLCLabeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.

Manufacturers of Mirtazapine (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsMIRTAZAPINE 15 mg/1Jul 15, 2026Sep 3, 2026
Aphena Pharma Solutions - Tennessee, LLCMIRTAZAPINE 15 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedMIRTAZAPINE 45 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedMIRTAZAPINE 15 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedMIRTAZAPINE 7.5 mg/1Jul 15, 2026Sep 3, 2026
Cardinal Health 107, LLCMIRTAZAPINE 15 mg/1Jul 15, 2026Sep 3, 2026
A-S Medication SolutionsMIRTAZAPINE 7.5 mg/1Jul 29, 2026Sep 2, 2026
Advanced Rx Pharmacy of Tennessee, LLCMIRTAZAPINE 15 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingMIRTAZAPINE 45 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingMIRTAZAPINE 30 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingMIRTAZAPINE 15 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingMIRTAZAPINE 7.5 mg/1Jul 15, 2026Sep 2, 2026
ANI Pharmaceuticals, Inc.MIRTAZAPINE 7.5 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.MIRTAZAPINE 45 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.MIRTAZAPINE 15 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.MIRTAZAPINE 30 mg/1Jul 15, 2026Sep 2, 2026
Atlantic Biologicals Corp.MIRTAZAPINE 7.5 mg/1Jul 15, 2026Sep 2, 2026
Aurolife Pharma LLCMIRTAZAPINE 15 mg/1Jul 15, 2026Sep 2, 2026
Aurolife Pharma LLCMIRTAZAPINE 45 mg/1Jul 15, 2026Sep 2, 2026
Aurolife Pharma LLCMIRTAZAPINE 7.5 mg/1Jul 15, 2026Sep 2, 2026
Aurolife Pharma LLCMIRTAZAPINE 30 mg/1Jul 15, 2026Sep 2, 2026
AvKAREMIRTAZAPINE 30 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackMIRTAZAPINE 30 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.MIRTAZAPINE 15 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.MIRTAZAPINE 30 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.MIRTAZAPINE 45 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.MIRTAZAPINE 7.5 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCMIRTAZAPINE 45 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCMIRTAZAPINE 7.5 mg/1Jul 15, 2026Sep 2, 2026
Direct_RxMIRTAZAPINE 30 mg/1Jul 15, 2026Sep 2, 2026
Direct_RxMIRTAZAPINE 15 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.MIRTAZAPINE 30 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.MIRTAZAPINE 45 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.MIRTAZAPINE 15 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsMIRTAZAPINE 15 mg/1Jul 15, 2026Sep 2, 2026
McKesson Corporation dba SKY PackagingMIRTAZAPINE 15 mg/1Jul 15, 2026Sep 2, 2026
McKesson Corporation dba SKY PackagingMIRTAZAPINE 30 mg/1Jul 15, 2026Sep 2, 2026
Mylan Institutional Inc.MIRTAZAPINE 45 mg/1Jul 15, 2026Sep 2, 2026
Mylan Institutional Inc.MIRTAZAPINE 15 mg/1Jul 15, 2026Sep 2, 2026
Mylan Institutional Inc.MIRTAZAPINE 30 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Mirtazapine — NDC 13107-0003-01," retrieved September 3, 2026, https://drugdashboards.com/drug/13107000301.

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