GALBRIELA

Orange BookSPL

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

Identification

ManufacturerXiromed, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7070030685
3 POUCH in 1 CARTON (70700-306-85) / 1 BLISTER PACK in 1 POUCH (70700-306-84) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A203371

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "47465e7e-64f2-690b-166e-0e1c3e5bec7a": {
      "match": "brand_token",
      "title": "GALBRIELA (NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [XIROMED, LLC]",
      "spl_version": "4",
      "published_date": "2025-02-07"
    }
  },
  "productid": "70700-306_8bfd4743-1a58-fcc9-de5c-6eb5ad6a0bc5",
  "productndc": "70700-306",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "203371",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.025MG;0.8MG",
        "product_no": "001",
        "approval_date": "Apr 23, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "GALBRIELA",
  "active_ingred_unit": null,
  "application_number": "ANDA203371",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone and ethinyl estradiol and ferrous fumarate",
  "start_marketing_date": "20250129",
  "active_numerator_strength": null
}

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