Medicine
Kyleena 19.5 mg intrauterine system
Kyleena 19.5 mg intrauterine system is a prescription medicine containing Levonorgestrel for intrauterine use, marketed by Bayer HealthCare 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), with excursions permitted between 15–30°C (59–86°F).
Key facts
- Active ingredient (INN)
- Levonorgestrel
- Brand
- Kyleena
- Strength
- 19.5 mg
- Dosage form
- Intrauterine system
- Route
- Intrauterine
- Packs
- 1 intrauterine device
- Marketing authorisation holder
- Bayer HealthCare Pharmaceuticals
- Manufacturer
- Bayer HealthCare Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), with excursions permitted between 15–30°C (59–86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G03AC03 Levonorgestrel
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 September 2016
- Identifiers
- RxCUI 1811886, 1856546DailyMed set ID 2e07c155-21e1-4781-9633-ce8bddd47080NDC 50419-424Application NDA208224
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 intrauterine device in 1 carton | 50419-424-01 | Bayer HealthCare Pharmaceuticals | 19 September 2016 |
| 1 intrauterine device in 1 carton | 50419-424-08 | Bayer HealthCare Pharmaceuticals | 19 September 2016 |
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 10 December 1990 | 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 Levonorgestrel
Clinical summary
Levonorgestrel is a progestin indicated for prevention of pregnancy for up to 8 years, among other approved uses. It is available as intrauterine systems and tablets for oral use. MedsAcross supplies Levonorgestrel 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 LevonorgestrelFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Mirena prescribing information (Bayer HealthCare Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Kyleena 19.5 mg intrauterine system 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.