United States· US:0378-3340_5cf2e689-da68-4a6a-8761-267a63244360
XULANE
A medicinal product containing norelgestromin and 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 and 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
- June 3, 2026
Packs & prices · 2
- ndc1103783340321 POUCH in 1 CARTON (0378-3340-32) / 1 PATCH in 1 POUCH (0378-3340-17) / 7 d in 1 PATCH
- ndc1103783340533 POUCH in 1 CARTON (0378-3340-53) / 1 PATCH in 1 POUCH (0378-3340-16) / 7 d in 1 PATCH
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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/d3816259-8c7a-43fd-9819-fc6d75ba1b7e GET /v1/drugs/d3816259-8c7a-43fd-9819-fc6d75ba1b7e?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",
"productid": "0378-3340_5cf2e689-da68-4a6a-8761-267a63244360",
"productndc": "0378-3340",
"dosage_form": "PATCH",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETHINYL ESTRADIOL; NORELGESTROMIN",
"proprietary_name": "XULANE",
"active_ingred_unit": "ug/d; ug/d",
"application_number": "ANDA200910",
"marketing_category": "ANDA",
"nonproprietary_name": "norelgestromin and ethinyl estradiol",
"start_marketing_date": "20140416",
"active_numerator_strength": "35; 150"
}See everything about norelgestromin and 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.