United States· US:50419-422_01b52e09-d273-4503-8589-a2bb64c1574c
Skyla
A medicinal product containing levonorgestrel, registered in United States by Bayer HealthCare Pharmaceuticals Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- LEVONORGESTREL
- Manufacturer
- Bayer HealthCare Pharmaceuticals Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc1150419422011 INTRAUTERINE DEVICE in 1 CARTON (50419-422-01)
- ndc1150419422081 INTRAUTERINE DEVICE in 1 CARTON (50419-422-08)
- ndc1150419-422-01
- ndc1150419-422-08
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Levonorgestrel in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomBenilexa One Handed 20micrograms/24hours intrauterine delivery systemGedeon Richter (UK) Ltd
- BelgiumEleonor 30 0.15 mg - 0.03 mgSandoz
- PolandEscapelle tabletka 1500 mikrogramówPretium Farm Sp. z o.o.
- SpainCUMBRAN 1,5 MG COMPRIMIDO EFGAristo Pharma Gmbh
- CzechiaEGIANTIEgis Pharmaceuticals PLC, Budapešť
- FinlandJadelleBayer Oy
- NetherlandsEtos noodanticonceptie levonorgestrel, 1,5 mg tabletSameko Farma B.V.
- SwedenFrivelle 1,5 mg TablettOrifarm Generics A/S
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Jaydess, Kyleena
- Belgium · Jaydess, Justine
- Bulgaria · Ескапел, Ескапеле
- Cyprus · Levosert, Levosert One
- Czechia · Egianti, Escapelle
- Germany · 28 Mini, Jaydess
- Denmark · Frivelle, Jaydess
- Estonia · Avodele, Donasert
- Spain · Cumbran, Jaydess
- Finland · Jadelle, Jadelle Sine Inserter
- France · Donasert, Jaydess
- United Kingdom (Northern Ireland) · Almus Emergency Contraceptive, Emerres
- Greece · Levonorgestrel Richter, Mirena
- Croatia · Escapelle, Levosert
- Hungary · Empil, Escapelle
- Ireland · Jaydess, Kyleena
- Iceland · Jaydess, Kyleena
- Italy · Benilexa, Escapelle
- Lithuania · Avodele, Cadele
- Luxembourg · Jaydess, Levonortis
- Latvia · Avodele, Escapelle
- Malta · Escapelle, Jaydess
- Netherlands · Isteranda, Kruidvat Noodanticonceptie
- Norway · Jaydess, Kyleena
- Poland · Escapelle, Kyleena
- Portugal · Cumbran, Gestanor
- Romania · Apreg, Emergana
- Sweden · Frivelle, Jaydess
- Slovenia · Escapelle, Kyleena
- Slovakia · Apreg, Escapelle
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/e258c04e-c8db-48a1-afe8-d1cd84b5a5a3 GET /v1/drugs/e258c04e-c8db-48a1-afe8-d1cd84b5a5a3?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "INTRAUTERINE",
"source": "ndc",
"strength": "13.5",
"substance": "LEVONORGESTREL",
"productndc": "50419-422",
"dosage_form": "INTRAUTERINE DEVICE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA203159",
"marketing_category": "NDA"
}See everything about levonorgestrel.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.