HAILEY Fe 1/20

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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
6846241929
3 BLISTER PACK in 1 CARTON (68462-419-29) / 1 KIT in 1 BLISTER PACK (68462-419-84)

Annotations

Orange Book

A206597

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": "68462-419_feb1bb19-095f-41f5-8e21-f291bec04d25",
  "productndc": "68462-419",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "206597",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.02MG;1MG",
        "product_no": "001",
        "approval_date": "Nov 21, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "HAILEY Fe 1/20",
  "active_ingred_unit": null,
  "application_number": "ANDA206597",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone acetate and ethinyl estradiol and ferrous fumarate",
  "start_marketing_date": "20171121",
  "active_numerator_strength": null
}

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