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United States · US · US:58602-892_6c3a0c42-b783-4b9f-a801-7b128ae38ff4

ITHAPPENZ MORNING AFTER

Orange BookUNIISPLATC G03AD01

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

Identification

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

Packs · 1

  • ndc11
    5860289257
    1 BLISTER PACK in 1 CARTON (58602-892-57) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
5W7SIA7YZW
LEVONORGESTREL
RxCUI 6373
Orange Book
A206867
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": {
    "5ee40793-0121-4b8f-b20d-3178bbe262e2": {
      "match": "brand_token",
      "title": "ITHAPPENZ MORNING AFTER (LEVONORGESTREL) TABLET [AUROHEALTH LLC]",
      "spl_version": "3",
      "published_date": "2025-04-09"
    }
  },
  "productid": "58602-892_6c3a0c42-b783-4b9f-a801-7b128ae38ff4",
  "productndc": "58602-892",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206867",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.5MG",
        "product_no": "001",
        "approval_date": "Dec 8, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LEVONORGESTREL",
  "proprietary_name": "ITHAPPENZ MORNING AFTER",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206867",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel",
  "start_marketing_date": "20221114",
  "active_numerator_strength": "1.5"
}

Related drugs

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