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United States · US · US:70700-326_87e7c941-eb02-5980-fc0e-08aee9b00f75

Gallifrey

Orange BookUNIISPLATC G03DC02

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

Identification

ManufacturerXiromed LLC
CountryUS (United States)
ATC codeG03DC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7070032650
    50 TABLET in 1 BOTTLE (70700-326-50)

Annotations

UNII (FDA Substance ID)
9S44LIC7OJ
NORETHINDRONE ACETATE
RxCUI 31983
Orange Book
A205278
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9S44LIC7OJ",
    "rxcui": "31983",
    "inchikey": "IMONTRJLAWHYGT-ZCPXKWAGSA-N",
    "display_name": "NORETHINDRONE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "26130af6-221b-2349-81b6-0c0132d6e524": {
      "match": "brand_token",
      "title": "GALLIFREY (NORETHINDRONE ACETATE) TABLET [XIROMED LLC]",
      "spl_version": "2",
      "published_date": "2025-07-31"
    }
  },
  "productid": "70700-326_87e7c941-eb02-5980-fc0e-08aee9b00f75",
  "productndc": "70700-326",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205278",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 10, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NORETHINDRONE ACETATE",
  "proprietary_name": "Gallifrey",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205278",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone Acetate",
  "start_marketing_date": "20240906",
  "active_numerator_strength": "5"
}

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