Medicine
Addyi 100 mg tablet
Addyi 100 mg tablet is a prescription medicine containing Flibanserin for oral use, marketed by Sprout Pharmaceuticals, 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 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F).
Key facts
- Active ingredient (INN)
- Flibanserin
- Brand
- Addyi
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Sprout Pharmaceuticals
- Manufacturer
- Sprout Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G02CX02 Flibanserin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 August 2015
- Identifiers
- RxCUI 1665514, 1666391DailyMed set ID 3819daf3-e935-2c53-c527-e1d57922f394NDC 58604-214Application NDA022526
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle | 58604-214-30 | Sprout Pharmaceuticals | 18 August 2015 |
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 18 August 2015 | 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
Clinical summary
Flibanserin is a prescription medicine indicated for the treatment of women less than 65 years of age with acquired, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Flibanserin 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 FlibanserinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ADDYI prescribing information (Sprout Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Addyi 100 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.