Quick answers
- What is Mirtazapine used for?
- The FDA-approved label (Remeronsoltab, Organon LLC, August 6, 2025) says: “REMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults […]. REMERON/REMERONSolTab is indicated for the treatment of major depressive disorder (MDD) in adults.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mirtazapine have a boxed warning?
- Yes. The FDA label for Remeronsoltab has a boxed warning (“WARNING: SUICIDAL THOUGHTS AND BEHAVIORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Mirtazapine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mirtazapine been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started March 18, 2020 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Mirtazapine?
- 37 companies list prescription products of Mirtazapine in the FDA NDC Directory, including Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC and Remedyrepack Inc..
What Mirtazapine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
REMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults […]. REMERON/REMERONSolTab is indicated for the treatment of major depressive disorder (MDD) in adults.
— FDA label: Remeronsoltab, Organon LLC, effective August 6, 2025. Read the full label on DailyMed →
The FDA has 86 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
. Read it on the full label →
84 of 86 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, orally disintegrating · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 144 in the FDA NDC Directory |
| Brand names | Remeronsoltab, Remeron |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| mirtazapine 15 mg tablet | Generic | $0.0624 per tablet |
| mirtazapine 15 mg tablet, film coated | Generic | $0.0624 per tablet |
| mirtazapine 15 mg tablet, film coated | Brand: Remeron | $6.36 per tablet |
| mirtazapine 15 mg tablet, orally disintegrating | Generic | $0.3082 per tablet |
| mirtazapine 30 mg tablet | Generic | $0.0897 per tablet |
| mirtazapine 30 mg tablet, film coated | Generic | $0.0897 per tablet |
| mirtazapine 30 mg tablet, film coated | Brand: Remeron | $6.67 per tablet |
| mirtazapine 30 mg tablet, orally disintegrating | Generic | $0.4028 per tablet |
| mirtazapine 45 mg tablet | Generic | $0.1179 per tablet |
| mirtazapine 45 mg tablet, film coated | Generic | $0.1179 per tablet |
| mirtazapine 45 mg tablet, orally disintegrating | Generic | $0.4238 per tablet |
| mirtazapine 7.5 mg tablet | Generic | $0.3426 per tablet |
| mirtazapine 7.5 mg tablet, film coated | Generic | $0.3426 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack19 products
- Aphena Pharma Solutions - Tennessee, LLC9 products
- Remedyrepack Inc.9 products
- Rising Pharma Holdings, Inc.7 products
- Aurobindo Pharma Limited7 products
- Coupler LLC6 products
- Proficient Rx LP5 products
- Organon LLC5 products
- A-S Medication Solutions5 products
- XLCare Pharmaceuticals, Inc.4 products
- Sun Pharmaceutical Industries, Inc.4 products
- Aurolife Pharma, LLC4 products
- Cardinal Health 107, LLC4 products
- American Health Packaging4 products
- Prasco Laboratories4 products
- Camber Pharmaceuticals, Inc.4 products
- Preferred Pharmaceuticals Inc.3 products
- Viona Pharmaceuticals Inc3 products
- Square Pharmaceuticals Limited3 products
- Golden State Medical Supply, Inc.3 products
- Apotex Corp.3 products
- NuCare Pharmaceuticals, Inc.3 products
- Mylan Institutional Inc.3 products
- Safecor Health LLC3 products
- Mylan Pharmaceuticals Inc.3 products
- NCS HealthCare of KY, Inc dba Vangard Labs2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Direct_Rx2 products
- McKesson Corporation dba SKY Packaging2 products
- AvKARE2 products
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Atlantic Biologicals Corp.1 product
- ANI Pharmaceuticals, Inc.1 product
- Major Pharmaceuticals1 product
- Redpharm Drug1 product
- NorthStar Rx LLC1 product
- Unit Dose Solutions, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020415 REMERON | Organon | June 14, 1996 | 30, latest July 23, 2025 2025: Manufacturing (CMC) · 2021: Labeling · 2020: Labeling |
| NDA021208 REMERON SOLTAB | Organon USA Organon | January 12, 2001 | 22, latest November 18, 2021 2021: Labeling · 2020: Labeling · 2020: Labeling |
Generic approvals (9)
- ANDA076122Mylan · June 19, 2003
- ANDA076541Sun Pharm Inds Inc · April 22, 2004
- ANDA076921Aurobindo · October 22, 2004
- ANDA077376Aurobindo Pharma · December 8, 2005
- ANDA077666Apotex · August 22, 2007
- ANDA205798Square Pharms PLC · June 1, 2017
- ANDA216751Prasco · January 18, 2023
- ANDA219721Annora Pharma · October 2, 2025
- ANDA219919Novitium Pharma · February 2, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 18, 2020 · Class II · Terminated · D-1235-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34 — Aurobindo Pharma USA Inc.
-
November 20, 2019 · Class I · Terminated · D-0636-2020
Labeling: 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.
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05 — AuroMedics Pharma LLC
-
November 20, 2019 · Class I · Terminated · D-0637-2020
Labeling: 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.
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05 — AuroMedics Pharma LLC
-
January 27, 2017 · Class II · Terminated · D-0493-2017
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20 — Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
-
January 19, 2017 · Class II · Terminated · D-0492-2017
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV — Mylan Pharmaceuticals Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Remeronsoltab, Organon LLC, effective August 6, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →