Doxepin 5% cream is a generic prescription medicine for topical 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 or below 27° C (80° F).
Key facts
- Active ingredient (INN)
- Doxepin
- Brand
- Sold under the generic name
- Strength
- 5%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 tube and 2 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaAmneal Pharmaceuticals NYMylan PharmaceuticalsTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at or below 27° C (80° F).
- 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
- 4 January 2019
- Identifiers
- RxCUI 1000091DailyMed set ID dd8d5edd-7b08-4061-86e6-c4179da89c0d, 4a4eab1c-8e19-48f5-9216-09ab83eaa5f8, 0d4bff5c-4e3d-459e-aba2-9c4c34b5ba7b +1NDC 69238-1733, 0093-9609, 51672-1404 +1Application ANDA212357, ANDA215408, ANDA213919 +1
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 |
|---|---|---|---|
| 1 tube in 1 carton / 30 g in 1 tube | 51672-1404-2 | Sun Pharmaceutical IndustriesIndia | 30 September 2026 |
| 1 tube in 1 carton / 45 g in 1 tube | 51672-1404-9 | Sun Pharmaceutical IndustriesIndia | 30 September 2026 |
| 1 tube in 1 carton / 45 g in 1 tube | 69238-1733-6 | Amneal Pharmaceuticals NY | 21 August 2023 |
| 1 tube in 1 carton / 45 g in 1 tube | 0378-8117-45 | Mylan Pharmaceuticals | 4 January 2019 |
| 1 tube in 1 carton / 45 g in 1 tube | 0093-9609-95 | Teva Pharmaceuticals | 17 February 2023 |
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
Alternatives
Other makers and brands of Doxepin 5% cream.
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 5% cream 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.