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United States · US · US:49702-250_9a0bc98a-3305-43f1-85bf-fb1e9ba88d45
Rukobia
Orange BookUNIISPLATC J05AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViiV Healthcare Company
CountryUS (United States)
ATC codeJ05AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1149702250181 BOTTLE in 1 CARTON (49702-250-18) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
2X513P36U0
FOSTEMSAVIR TROMETHAMINE
RxCUI 2380374
Orange Book
N212950
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2X513P36U0",
"rxcui": "2380374",
"inchikey": "RRGJSMBMTOKHTE-UHFFFAOYSA-N",
"display_name": "FOSTEMSAVIR TROMETHAMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a21006b7-6d6f-4f06-81b4-17978756452b": {
"match": "brand_token",
"title": "RUKOBIA (FOSTEMSAVIR TROMETHAMINE) TABLET, FILM COATED, EXTENDED RELEASE [VIIV HEALTHCARE COMPANY]",
"spl_version": "8",
"published_date": "2025-06-12"
}
},
"productid": "49702-250_9a0bc98a-3305-43f1-85bf-fb1e9ba88d45",
"productndc": "49702-250",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "212950",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 600MG BASE",
"product_no": "001",
"approval_date": "Jul 2, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FOSTEMSAVIR TROMETHAMINE",
"proprietary_name": "Rukobia",
"active_ingred_unit": "mg/1",
"application_number": "NDA212950",
"marketing_category": "NDA",
"nonproprietary_name": "fostemsavir tromethamine",
"start_marketing_date": "20200702",
"active_numerator_strength": "600"
}Related drugs
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