Doxepin 25 mg capsule is a generic prescription medicine for oral use, made by 31 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). Protect from light.
Key facts
- Active ingredient (INN)
- Doxepin
- Brand
- Sold under the generic name
- Strength
- 25 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 1000 capsules, 500 capsules and 86 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAjanta PharmaIndiaLifestar PharmaIndiaNovadoz PharmaceuticalsIndiaAurobindo PharmaIndiaAvet PharmaceuticalsIndiaBryant Ranch PrepackAmneal PharmaceuticalsAppco PharmaBlu Pharmaceuticals31 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 13 May 1986
- Identifiers
- RxCUI 1000048, 1000058, 1000070 +2DailyMed set ID 8f7e9677-cc84-414b-8eb8-33993d285bb3, df3b6be0-6a64-4174-b351-dab2061f290e, 137a953b-3c48-405f-86a6-ff778cb7f5f2 +37NDC 72789-334, 0904-7053, 51079-437 +37Application ANDA213474, ANDA207482, ANDA070791 +11
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 31 labelers. The register lists 89 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle | 46708-638-31 | Alembic PharmaceuticalsIndia | 23 April 2021 |
| 1000 capsule in 1 bottle | 46708-638-91 | Alembic PharmaceuticalsIndia | 23 April 2021 |
| 100 capsule in 1 bottle | 62332-638-31 | Alembic PharmaceuticalsIndia | 23 April 2021 |
| 1000 capsule in 1 bottle | 62332-638-91 | Alembic PharmaceuticalsIndia | 23 April 2021 |
| 100 capsule in 1 bottle | 27241-168-01 | Ajanta PharmaIndia | 20 December 2019 |
| 1000 capsule in 1 bottle | 27241-168-10 | Ajanta PharmaIndia | 20 February 2020 |
| 100 capsule in 1 bottle | 59651-174-01 | Aurobindo PharmaIndia | 27 March 2019 |
| 100 capsule in 1 bottle | 23155-795-01 | Avet PharmaceuticalsIndia | 30 December 2021 |
| 100 capsule in 1 bottle | 70756-425-11 | Lifestar PharmaIndia | 10 February 2022 |
| 500 capsule in 1 bottle | 70756-425-51 | Lifestar PharmaIndia | 10 February 2022 |
| 100 capsule in 1 bottle, plastic | 72205-089-91 | Novadoz PharmaceuticalsIndia | 27 June 2022 |
| 1000 capsule in 1 bottle, plastic | 72205-089-99 | Novadoz PharmaceuticalsIndia | 27 June 2022 |
| 1000 capsule in 1 bottle | 69238-1170-1 | Amneal Pharmaceuticals | 28 June 2017 |
| 30 capsule in 1 bottle | 69238-1170-3 | Amneal Pharmaceuticals | 28 June 2017 |
| 90 capsule in 1 bottle | 69238-1170-9 | Amneal Pharmaceuticals | 28 June 2017 |
| 100 capsule in 1 bottle | 55801-528-01 | Appco Pharma | 1 June 2021 |
| 500 capsule in 1 bottle | 55801-528-02 | Appco Pharma | 1 June 2021 |
| 100 capsule in 1 bottle | 24658-794-01 | Blu Pharmaceuticals | 14 March 2023 |
| 1000 capsule in 1 bottle | 24658-794-10 | Blu Pharmaceuticals | 14 March 2023 |
| 30 capsule in 1 blister pack | 83209-638-30 | BPS Wholesale | 4 September 2024 |
| 1000 capsule in 1 bottle | 10267-5060-4 | Contract Pharmacal | 24 January 2021 |
| 90 capsule in 1 bottle | 10267-5060-9 | Contract Pharmacal | 24 January 2021 |
| 100 capsule in 1 bottle | 42806-530-01 | Epic Pharma | 6 June 2017 |
| 1000 capsule in 1 bottle | 42806-530-10 | Epic Pharma | 6 June 2017 |
| 100 capsule in 1 bottle | 81469-416-01 | First Nation Group | 11 January 2023 |
| 500 capsule in 1 bottle | 81469-416-05 | First Nation Group | 11 January 2023 |
| 100 capsule in 1 bottle | 71921-163-01 | Florida Pharmaceutical Products | 1 May 2021 |
| 100 capsule in 1 package | 69315-159-01 | Leading Pharma | 15 April 2021 |
| 1000 capsule in 1 package | 69315-159-10 | Leading Pharma | 15 April 2021 |
| 100 blister pack in 1 carton / 1 capsule in 1 blister pack | 51079-437-20 | Mylan Institutional | 8 May 1998 |
| 100 capsule in 1 bottle, plastic | 0378-3125-01 | Mylan Pharmaceuticals | 13 May 1986 |
| 1000 capsule in 1 bottle, plastic | 0378-3125-10 | Mylan Pharmaceuticals | 13 May 1986 |
| 100 capsule in 1 bottle | 64980-595-01 | Rising Pharma Holdings | 25 December 2023 |
| 30 capsule in 1 bottle | 63629-5033-1 | Bryant Ranch Prepack | 12 June 2013 |
| 60 capsule in 1 bottle | 63629-5033-2 | Bryant Ranch Prepack | 2 June 2016 |
| 28 capsule in 1 bottle | 63629-5033-3 | Bryant Ranch Prepack | 8 October 2024 |
| 18 capsule in 1 bottle | 63629-5033-4 | Bryant Ranch Prepack | 8 October 2024 |
| 90 capsule in 1 bottle | 63629-5033-5 | Bryant Ranch Prepack | 8 October 2024 |
| 30 capsule in 1 bottle | 71335-1941-1 | Bryant Ranch Prepack | 29 December 2021 |
| 60 capsule in 1 bottle | 71335-1941-2 | Bryant Ranch Prepack | 29 December 2021 |
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 23 September 1969 | 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 Doxepin
Clinical summary
Doxepin is a tricyclic antidepressant indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. MedsAcross supplies Doxepin 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 DoxepinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PRUDOXIN prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Doxepin 25 mg capsule 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.