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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
- ndc11707003265050 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"
}Related drugs
Other records sharing ATC code G03DC02.
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