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United States · US · US:50742-352_9ebc666c-47b1-477a-a9e0-8a761b809ccc

Her Style

Orange BookUNIISPLATC G03AD01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerIngenus Pharmaceuticals, LLC
CountryUS (United States)
ATC codeG03AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5074235201
    1 BLISTER PACK in 1 CARTON (50742-352-01) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
5W7SIA7YZW
LEVONORGESTREL
RxCUI 6373
Orange Book
A207976
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": "ORAL",
  "spl_meta": {
    "6e631755-b7c5-4a3a-b46d-f66b4ceedb1c": {
      "match": "brand_token",
      "title": "HER STYLE (LEVONORGESTREL) TABLET [INGENUS PHARMACEUTICALS, LLC]",
      "spl_version": "3",
      "published_date": "2025-12-10"
    }
  },
  "productid": "50742-352_9ebc666c-47b1-477a-a9e0-8a761b809ccc",
  "productndc": "50742-352",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207976",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.5MG",
        "product_no": "001",
        "approval_date": "Mar 11, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LEVONORGESTREL",
  "proprietary_name": "Her Style",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207976",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levonorgestrel",
  "start_marketing_date": "20221130",
  "active_numerator_strength": "1.5"
}

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