Medicine
Mirtazapine 45 mg orally disintegrating tablet
Mirtazapine 45 mg orally disintegrating tablet is a generic prescription medicine for oral use, made by 4 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° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Mirtazapine
- Brand
- Sold under the generic name
- Strength
- 45 mg
- Dosage form
- Orally disintegrating tablet
- Route
- Oral
- Packs
- 100 tablets, 5 blister pack, 30 tablets and 5 more
- Manufacturers
- Aurobindo PharmaIndiaViona PharmaceuticalsIndiaRising Pharma HoldingsSquare Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° 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
- 28 February 2006
- Identifiers
- RxCUI 283406, 283407, 283485DailyMed set ID 73b7bbd9-7dba-4559-890f-3f8dd821e215, 83093852-d212-408e-98fd-33f4603a9d65, ed491abe-9412-428b-8e24-57242862c99a +1NDC 57237-013, 76483-112, 72578-105 +1Application ANDA077376, ANDA205798
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, orally disintegrating in 1 bottle | 65862-023-01 | Aurobindo PharmaIndia | 28 February 2006 |
| 5 blister pack in 1 carton / 6 tablet, orally disintegrating in 1 blister pack | 65862-023-06 | Aurobindo PharmaIndia | 28 February 2006 |
| 30 tablet, orally disintegrating in 1 bottle | 65862-023-30 | Aurobindo PharmaIndia | 28 February 2006 |
| 60 tablet, orally disintegrating in 1 bottle | 65862-023-60 | Aurobindo PharmaIndia | 28 February 2006 |
| 90 tablet, orally disintegrating in 1 bottle | 65862-023-90 | Aurobindo PharmaIndia | 28 February 2006 |
| 5 blister pack in 1 carton / 6 tablet, orally disintegrating in 1 blister pack | 72578-105-84 | Viona PharmaceuticalsIndia | 7 August 2022 |
| 5 blister pack in 1 carton / 6 tablet, orally disintegrating in 1 blister pack | 57237-013-06 | Rising Pharma Holdings | 28 February 2006 |
| 30 tablet, orally disintegrating in 1 carton | 76483-112-00 | Square Pharmaceuticals | 15 November 2022 |
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
Alternatives
Other makers and brands of Mirtazapine 45 mg orally disintegrating tablet.
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 orally disintegrating 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.