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United States · US · US:68180-911_4da34ed3-8449-46a5-b662-b30042df51eb

Mibelas 24 Fe

Orange BookSPL

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

Identification

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

Packs · 1

  • ndc11
    6818091173
    3 POUCH in 1 CARTON (68180-911-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A206287
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "7281519c-069c-4ce3-a076-49848ad4ee7b": {
      "match": "brand_token",
      "title": "MIBELAS 24 FE (NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "7",
      "published_date": "2025-12-09"
    }
  },
  "productid": "68180-911_4da34ed3-8449-46a5-b662-b30042df51eb",
  "productndc": "68180-911",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "206287",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.02MG;1MG",
        "product_no": "001",
        "approval_date": "May 24, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Mibelas 24 Fe",
  "active_ingred_unit": null,
  "application_number": "ANDA206287",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATE",
  "start_marketing_date": "20200331",
  "active_numerator_strength": null
}

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