Medicine
Mirtazapine 45 mg tablet
Mirtazapine 45 mg tablet is a generic prescription medicine for oral use, made by 18 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Mirtazapine
- Brand
- Sold under the generic name
- Strength
- 45 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 47 more
- Manufacturers
- Aurobindo PharmaIndiaAurolife PharmaIndiaCamber PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaBryant Ranch PrepackApotexMylan PharmaceuticalsGolden State Medical SupplyRising Pharma HoldingsXLCare Pharmaceuticals18 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N06AX11 Mirtazapine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 June 2003
- Identifiers
- RxCUI 311725, 311726, 314111 +1DailyMed set ID b6b31703-e77d-4d1a-b1ac-da972117e356, 711aa80b-8fc6-49e6-9494-3db31d9b53a4, 1b13d7ec-ecdc-482c-8fe2-b999bab3bbeb +16NDC 72865-371, 0378-3545, 70518-2581 +16Application ANDA219721, ANDA076122, ANDA076921 +3
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 18 labelers. The register lists 50 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 65862-032-01 | Aurobindo PharmaIndia | 22 October 2004 |
| 500 tablet, film coated in 1 bottle | 65862-032-05 | Aurobindo PharmaIndia | 22 October 2004 |
| 30 tablet, film coated in 1 bottle | 65862-032-30 | Aurobindo PharmaIndia | 22 October 2004 |
| 30 tablet, film coated in 1 blister pack | 65862-032-32 | Aurobindo PharmaIndia | 22 October 2004 |
| 60 tablet, film coated in 1 bottle | 65862-032-60 | Aurobindo PharmaIndia | 22 October 2004 |
| 90 tablet, film coated in 1 bottle | 65862-032-90 | Aurobindo PharmaIndia | 22 October 2004 |
| 100 tablet, film coated in 1 bottle | 13107-032-01 | Aurolife PharmaIndia | 17 August 2009 |
| 500 tablet, film coated in 1 bottle | 13107-032-05 | Aurolife PharmaIndia | 17 August 2009 |
| 30 tablet, film coated in 1 blister pack | 13107-032-32 | Aurolife PharmaIndia | 17 August 2009 |
| 30 tablet, film coated in 1 bottle | 13107-032-34 | Aurolife PharmaIndia | 17 August 2009 |
| 60 tablet, film coated in 1 bottle | 13107-032-60 | Aurolife PharmaIndia | 17 August 2009 |
| 90 tablet, film coated in 1 bottle | 13107-032-90 | Aurolife PharmaIndia | 17 August 2009 |
| 500 tablet, film coated in 1 bottle | 31722-410-05 | Camber PharmaceuticalsIndia | 2 October 2025 |
| 30 tablet, film coated in 1 bottle | 31722-410-30 | Camber PharmaceuticalsIndia | 2 October 2025 |
| 1000 tablet in 1 bottle | 57664-501-18 | Sun Pharmaceutical IndustriesIndia | 22 April 2017 |
| 30 tablet in 1 bottle | 57664-501-83 | Sun Pharmaceutical IndustriesIndia | 22 April 2004 |
| 30 tablet, film coated in 1 bottle | 60505-0249-1 | Apotex | 22 August 2007 |
| 100 tablet, film coated in 1 bottle | 60505-0249-3 | Apotex | 22 August 2007 |
| 500 tablet, film coated in 1 bottle | 60505-0249-5 | Apotex | 22 August 2007 |
| 1000 tablet, film coated in 1 bottle | 60505-0249-8 | Apotex | 22 August 2007 |
| 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 51079-088-20 | Mylan Institutional | 1 August 2003 |
| 100 tablet, film coated in 1 bottle, plastic | 0378-3545-01 | Mylan Pharmaceuticals | 2 August 2016 |
| 500 tablet, film coated in 1 bottle, plastic | 0378-3545-05 | Mylan Pharmaceuticals | 20 June 2003 |
| 30 tablet, film coated in 1 bottle, plastic | 0378-3545-93 | Mylan Pharmaceuticals | 20 June 2003 |
| 500 tablet, film coated in 1 bottle | 57237-010-05 | Rising Pharma Holdings | 22 October 2004 |
| 30 tablet, film coated in 1 bottle | 57237-010-30 | Rising Pharma Holdings | 22 October 2004 |
| 500 tablet, film coated in 1 bottle | 72865-371-05 | XLCare Pharmaceuticals | 2 October 2025 |
| 30 tablet, film coated in 1 bottle | 72865-371-30 | XLCare Pharmaceuticals | 2 October 2025 |
| 30 tablet, film coated in 1 bottle | 63629-3346-1 | Bryant Ranch Prepack | 27 January 2010 |
| 90 tablet, film coated in 1 bottle | 63629-3346-2 | Bryant Ranch Prepack | 7 March 2014 |
| 60 tablet, film coated in 1 bottle | 63629-3346-3 | Bryant Ranch Prepack | 8 March 2022 |
| 28 tablet, film coated in 1 bottle | 63629-3346-4 | Bryant Ranch Prepack | 8 March 2022 |
| 30 tablet, film coated in 1 bottle | 71335-1332-1 | Bryant Ranch Prepack | 5 September 2019 |
| 90 tablet, film coated in 1 bottle | 71335-1332-2 | Bryant Ranch Prepack | 3 April 2024 |
| 60 tablet, film coated in 1 bottle | 71335-1332-3 | Bryant Ranch Prepack | 3 April 2024 |
| 28 tablet, film coated in 1 bottle | 71335-1332-4 | Bryant Ranch Prepack | 3 April 2024 |
| 100 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack | 68084-121-01 | American Health Packaging | 5 January 2006 |
| 30 tablet, film coated in 1 blister pack | 67046-2024-3 | Coupler | 1 June 2026 |
| 500 tablet, film coated in 1 bottle, plastic | 51407-352-05 | Golden State Medical Supply | 21 February 2020 |
| 30 tablet, film coated in 1 bottle, plastic | 51407-352-30 | Golden State Medical Supply | 21 February 2020 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 14 June 1996 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Mirtazapine
Clinical summary
Mirtazapine is a prescription medicine indicated for the treatment of major depressive disorder (MDD) in adults. It is available as tablets and orally disintegrating tablets. MedsAcross supplies Mirtazapine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MirtazapineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- REMERONSOLTAB prescribing information (Organon) · U.S. National Library of Medicine, DailyMed
Need Mirtazapine 45 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.