Hailey Fe 1.5/30

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
6846250329
3 POUCH in 1 CARTON (68462-503-29) / 1 BLISTER PACK in 1 POUCH (68462-503-84) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A209031

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": "68462-503_f209a6e5-4e23-42b9-b43e-529628c302a5",
  "productndc": "68462-503",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "209031",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;1.5MG",
        "product_no": "001",
        "approval_date": "Jun 5, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Hailey Fe 1.5/30",
  "active_ingred_unit": null,
  "application_number": "ANDA209031",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate",
  "start_marketing_date": "20180605",
  "active_numerator_strength": null
}

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