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United States · US · US:50419-422_01b52e09-d273-4503-8589-a2bb64c1574c
Skyla
Orange BookUNIISPLATC G03AD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG03AD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150419422011 INTRAUTERINE DEVICE in 1 CARTON (50419-422-01)
- ndc1150419422081 INTRAUTERINE DEVICE in 1 CARTON (50419-422-08)
Annotations
UNII (FDA Substance ID)
5W7SIA7YZW
LEVONORGESTREL
RxCUI 6373
Orange Book
N203159
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5W7SIA7YZW",
"rxcui": "6373",
"inchikey": "WWYNJERNGUHSAO-XUDSTZEESA-N",
"display_name": "LEVONORGESTREL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAUTERINE",
"spl_meta": {
"9f44ff35-e052-49cd-a1c2-0bfd87d49309": {
"match": "brand_token",
"title": "SKYLA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "22",
"published_date": "2026-03-05"
}
},
"productid": "50419-422_01b52e09-d273-4503-8589-a2bb64c1574c",
"productndc": "50419-422",
"dosage_form": "INTRAUTERINE DEVICE",
"orange_book": {
"appl_no": "203159",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "13.5MG",
"product_no": "001",
"approval_date": "Jan 9, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVONORGESTREL",
"proprietary_name": "Skyla",
"active_ingred_unit": "mg/1",
"application_number": "NDA203159",
"marketing_category": "NDA",
"nonproprietary_name": "Levonorgestrel",
"start_marketing_date": "20130111",
"active_numerator_strength": "13.5"
}Related drugs
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