United States· US:0378-3340_fb5b221c-cac1-4530-9c98-d485754a8266
XULANE
A medicinal product containing norelgestromin; ethinyl estradiol, registered in United States by Mylan 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
- NORELGESTROMIN; ETHINYL ESTRADIOL
- Manufacturer
- Mylan 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 · 1
- ndc110378-3340-53
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Norelgestromin; ethinyl estradiol in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainEVRA 203 MICROGRAMOS/24 hORAS + 33,9 MICROGRAMOS/24 HORAS PARCHE TRANSDERMICOJanssen-Cilag International N.V
- CzechiaEVRAGedeon Richter Plc., Budapešť
- United KingdomEvra transdermal patchesGedeon Richter (UK) Ltd
- IrelandEvraGedeon Richter Plc
- SwitzerlandEvra, transdermales PatchGedeon Richter (Schweiz) AG
- FinlandEvraGedeon Richter Plc
- CanadaEVRASEARCHLIGHT PHARMA INC
- IcelandEvraGedeon Richter Plc.*
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Evra
- Liechtenstein · Evra
- Norway · Evra
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/cb876ab1-cf8a-4277-86f8-710e897f11de GET /v1/drugs/cb876ab1-cf8a-4277-86f8-710e897f11de?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": "TRANSDERMAL",
"source": "ndc",
"strength": "150; 35",
"substance": "NORELGESTROMIN; ETHINYL ESTRADIOL",
"productndc": "0378-3340",
"dosage_form": "PATCH",
"dea_schedule": null,
"strength_unit": "ug/d; ug/d",
"application_number": "ANDA200910",
"marketing_category": "ANDA"
}See everything about norelgestromin; ethinyl estradiol.
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.