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United States · US · US:50419-424_e22aea7f-9d28-426d-879a-4723fa76f2c2

Kyleena

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 · 3

  • ndc11
    5041942401
    1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01)
  • ndc11
    5041942408
    1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-08)
  • ndc11
    5041942471
    1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-71)

Annotations

UNII (FDA Substance ID)
5W7SIA7YZW
LEVONORGESTREL
RxCUI 6373
Orange Book
N208224
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": {
    "2e07c155-21e1-4781-9633-ce8bddd47080": {
      "match": "brand_token",
      "title": "KYLEENA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
      "spl_version": "13",
      "published_date": "2025-11-17"
    }
  },
  "productid": "50419-424_e22aea7f-9d28-426d-879a-4723fa76f2c2",
  "productndc": "50419-424",
  "dosage_form": "INTRAUTERINE DEVICE",
  "orange_book": {
    "appl_no": "208224",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "19.5MG",
        "product_no": "001",
        "approval_date": "Sep 16, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVONORGESTREL",
  "proprietary_name": "Kyleena",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208224",
  "marketing_category": "NDA",
  "nonproprietary_name": "Levonorgestrel",
  "start_marketing_date": "20160919",
  "active_numerator_strength": "19.5"
}

Related drugs

Other records sharing ATC code G03AD01.

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