Drug
Who makes mirtazapine?
36 companies list mirtazapine as a human prescription drug, including under the names REMERON, REMERONSOLTAB. Forms: tablet; tablet, film coated; tablet, orally disintegrating. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing mirtazapine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | tablet; tablet, film coated; tablet, orally disintegrating | ANDAANDA076541, ANDA076921, ANDA077376 | 19 | 1 |
| RemedyRepack, IncUnited States | tablet; tablet, film coated | ANDAANDA076122, ANDA076541, ANDA076921 | 9 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet; tablet, film coated | ANDAANDA076122, ANDA076541, ANDA076921 | 9 | 0 |
| Rising Pharma Holdings, Inc.United States | tablet, film coated; tablet, orally disintegrating | ANDAANDA076921, ANDA077376 | 7 | 1 |
| Coupler LLCUnited States | tablet, film coated | ANDAANDA076921, ANDA077666 | 6 | 1 |
| Organon LLCNetherlands | tablet, film coated; tablet, orally disintegrating | NDANDA020415, NDA021208 | 5 | 4 |
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA076921, ANDA077666, ANDA219721 | 5 | 3 |
| Proficient Rx LPUnited States | tablet, film coated | ANDAANDA076921, ANDA077666 | 5 | 1 |
| Cardinal Health 418, Inc.United States | tablet, film coated; tablet, orally disintegrating | ANDAANDA076122, ANDA077376, ANDA077666 | 4 | 34 |
| Sun Pharmaceutical Industries LimitedIndia | tablet | ANDAANDA076541 | 4 | 13 |
| Aurobindo Pharma LimitedIndia | tablet, film coated; tablet, orally disintegrating | ANDAANDA076921, ANDA077376 | 4 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, film coated | ANDAANDA076921 | 4 | 5 |
| Aurolife Pharma LLCUnited States | tablet, film coated | ANDAANDA076921 | 4 | 3 |
| Camber Pharmaceuticals, Inc.United States | tablet, film coated | ANDAANDA219721 | 4 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, film coated | ANDAANDA076921, ANDA219919 | 4 | 1 |
| XLCare Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA219721 | 4 | 1 |
| Prasco Laboratories | tablet, film coated | ANDAANDA216751 | 4 | 0 |
| Apotex Inc.Canada | tablet, film coated | ANDAANDA077666 | 3 | 6 |
| Safecor Health, LLCUnited States | tablet, film coated | ANDAANDA076122 | 3 | 3 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA076122 | 3 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet, film coated | ANDAANDA076921 | 3 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA076921 | 3 | 1 |
| SQUARE PHARMACEUTICALS PLC.Bangladesh | tablet, orally disintegrating | ANDAANDA205798 | 3 | 1 |
| Mylan Institutional Inc. | tablet, film coated | ANDAANDA076122 | 3 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet, film coated | ANDAANDA076122 | 3 | 0 |
| Viona Pharmaceuticals Inc. | tablet, orally disintegrating | ANDAANDA205798 | 3 | 0 |
| Direct RxUnited States | tablet, film coated | ANDAANDA076921, ANDA077666 | 2 | 1 |
| AvKARE | tablet; tablet, film coated | ANDAANDA076541, ANDA077666 | 2 | 0 |
| Mckesson Corporation DBA SKY Packaginng | tablet, film coated | ANDAANDA077666 | 2 | 0 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet, film coated | ANDAANDA076921 | 1 | 1 |
| ANI Pharmaceuticals, Inc.United States | tablet, film coated | ANDAANDA219919 | 1 | 1 |
| RedPharm DrugUnited States | tablet, film coated | ANDAANDA076921 | 1 | 1 |
| South Atlantic Corporation LLCUnited States | tablet, film coated | ANDAANDA076921 | 1 | 1 |
| Unit Dose Solutions, Inc.United States | tablet, film coated | ANDAANDA076921 | 1 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA077666 | 1 | 0 |
| Northstar Rx, LLC, | tablet, film coated | ANDAANDA076921 | 1 | 0 |
Bulk ingredient listings
- Maithri Drugs Private LimitedIndia · 2 NDC
- Aspen Oss B.V.Netherlands · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Matrix Pharmacorp Private LimitedIndia · 1 NDC
- Medichem SASpain · 1 NDC
- Neuland Laboratories LimitedIndia · 1 NDC
- RAKSHIT DRUGS PRIVATE LIMITEDIndia · 1 NDC
Enquiry
Common questions
- Who makes mirtazapine?
- 36 companies list mirtazapine as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, RemedyRepack, Inc, Aphena Pharma Solutions - Tennessee, LLC, Rising Pharma Holdings, Inc., Coupler LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic REMERON?
- 35 companies list mirtazapine under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies mirtazapine active ingredient?
- 9 companies list mirtazapine as a bulk ingredient, including Maithri Drugs Private Limited, Aspen Oss B.V., Darmerica, LLC, Hetero Drugs Limited.