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United States · US · US:61958-0703_32422ee8-1cdc-4305-bb3e-0458472513fc
Truvada
Orange BookUNIISPLATC J05AF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGilead Sciences, Inc
CountryUS (United States)
ATC codeJ05AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11619580703130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0703-1)
Annotations
UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
N021752
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G70B4ETF4S",
"rxcui": "276237",
"inchikey": "XQSPYNMVSIKCOC-NTSWFWBYSA-N",
"display_name": "EMTRICITABINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"54e82b13-a037-49ed-b4b3-030b37c0ecdd": {
"match": "brand_token",
"title": "TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]",
"spl_version": "32",
"published_date": "2025-07-25"
}
},
"productid": "61958-0703_32422ee8-1cdc-4305-bb3e-0458472513fc",
"productndc": "61958-0703",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021752",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "200MG;300MG",
"product_no": "001",
"approval_date": "Aug 2, 2004"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "100MG;150MG",
"product_no": "002",
"approval_date": "Mar 10, 2016"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "133MG;200MG",
"product_no": "003",
"approval_date": "Mar 10, 2016"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "167MG;250MG",
"product_no": "004",
"approval_date": "Mar 10, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"proprietary_name": "Truvada",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA021752",
"marketing_category": "NDA",
"nonproprietary_name": "emtricitabine and tenofovir disoproxil fumarate",
"start_marketing_date": "20160310",
"active_numerator_strength": "100; 150"
}Related drugs
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