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United States · US · US:70700-310_817ee8b8-f24d-0dfd-e969-2f5ef8d8cbb8

XARAH FE

Orange BookSPL

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

Identification

ManufacturerXiromed LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7070031085
    3 POUCH in 1 CARTON (70700-310-85) / 1 BLISTER PACK in 1 POUCH (70700-310-84) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A205069
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "2c5cf9c3-948e-964b-7424-21c84461df93": {
      "match": "brand_token",
      "title": "XARAH FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE TABLETS) KIT [XIROMED LLC]",
      "spl_version": "2",
      "published_date": "2025-02-07"
    }
  },
  "productid": "70700-310_817ee8b8-f24d-0dfd-e969-2f5ef8d8cbb8",
  "productndc": "70700-310",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "205069",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.02MG,0.03MG,0.035MG;1MG,1MG,1MG",
        "product_no": "001",
        "approval_date": "Jun 22, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "XARAH FE",
  "active_ingred_unit": null,
  "application_number": "ANDA205069",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone acetate and ethinyl estradiol and ferrous fumarate tablets",
  "start_marketing_date": "20250129",
  "active_numerator_strength": null
}

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