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United States · US · US:61958-2301_175f5d1a-aae9-43d5-b004-65eefec167d4
VEMLIDY
Orange BookUNIISPLATC J05AF13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeJ05AF13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11619582301130 TABLET in 1 BOTTLE, PLASTIC (61958-2301-1)
Annotations
UNII (FDA Substance ID)
FWF6Q91TZO
TENOFOVIR ALAFENAMIDE FUMARATE
RxCUI 1721604
Orange Book
N208464
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "FWF6Q91TZO",
"rxcui": "1721604",
"inchikey": "SVUJNSGGPUCLQZ-FQQAACOVSA-N",
"display_name": "TENOFOVIR ALAFENAMIDE FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"72e6b33c-0351-4070-9172-eeaa186c01d2": {
"match": "brand_token",
"title": "VEMLIDY (TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.]",
"spl_version": "17",
"published_date": "2025-07-25"
}
},
"productid": "61958-2301_175f5d1a-aae9-43d5-b004-65eefec167d4",
"productndc": "61958-2301",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208464",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Nov 10, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TENOFOVIR ALAFENAMIDE FUMARATE",
"proprietary_name": "VEMLIDY",
"active_ingred_unit": "mg/1",
"application_number": "NDA208464",
"marketing_category": "NDA",
"nonproprietary_name": "tenofovir alafenamide",
"start_marketing_date": "20161110",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code J05AF13.
- NLTenofoviralafenamide Devatis 25 mg, filmomhulde tablettenDevatis GmbH
- DKVemlidyGilead Sciences Ireland UC
- NOVemlidyAbacus Medicine A/S
- ISVemlidyGilead Sciences Ireland UC*
- NOVemlidyGilead Sciences Ireland UC
- PLVemlidyGilead Sciences Ireland UC
- 🇨🇭VemlidyGilead Sciences Switzerland Sàrl
- FIVemlidyGilead Sciences Ireland UC
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