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United States · US · US:68462-731_12f7a9d2-4627-40c2-987f-202a9aad27de

Hailey 24 Fe

Orange BookSPL

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

Identification

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

Packs · 1

  • ndc11
    6846273129
    3 BLISTER PACK in 1 CARTON (68462-731-29) / 1 KIT in 1 BLISTER PACK (68462-731-84)

Annotations

Orange Book
A204847
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "84f6d573-3022-4982-aaa4-ac69393210a2": {
      "match": "brand_token",
      "title": "HAILEY FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [GLENMARK PHARMACEUTICALS INC., USA]",
      "spl_version": "11",
      "published_date": "2026-02-02"
    }
  },
  "productid": "68462-731_12f7a9d2-4627-40c2-987f-202a9aad27de",
  "productndc": "68462-731",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "204847",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.02MG;1MG",
        "product_no": "001",
        "approval_date": "Nov 17, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Hailey 24 Fe",
  "active_ingred_unit": null,
  "application_number": "ANDA204847",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone acetate and ethinyl estradiol, and ferrous fumarate",
  "start_marketing_date": "20171117",
  "active_numerator_strength": null
}

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