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United States · US · US:72495-601_5bfa2209-e9bb-4d9b-97cb-2f8cd0058178

FEMLYV

Orange BookSPL

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

Identification

ManufacturerMillicent US, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7249560128
    1 POUCH in 1 CARTON (72495-601-28) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
  • ndc11
    7249560184
    3 POUCH in 1 CARTON (72495-601-84) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
N218718
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "a3c99fc1-9b05-4f0a-ad00-5e3e206302c9": {
      "match": "brand_token",
      "title": "FEMLYV (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) KIT [MILLICENT US, INC.]",
      "spl_version": "3",
      "published_date": "2025-09-15"
    }
  },
  "productid": "72495-601_5bfa2209-e9bb-4d9b-97cb-2f8cd0058178",
  "productndc": "72495-601",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "218718",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.02MG;1MG",
        "product_no": "001",
        "approval_date": "Jul 22, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "FEMLYV",
  "active_ingred_unit": null,
  "application_number": "NDA218718",
  "marketing_category": "NDA",
  "nonproprietary_name": "Norethindrone Acetate/Ethinyl Estradiol",
  "start_marketing_date": "20241101",
  "active_numerator_strength": null
}

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