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United States · US · US:50090-7719_09d2278c-577b-400f-a781-7be3f5b07834
Emtricitabine and tenofovir disoproxil fumarate
Orange BookUNIISPLATC J05AF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ05AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11500907719130 TABLET, FILM COATED in 1 BOTTLE (50090-7719-1)
Annotations
UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
A201806
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": {
"4feb83a5-9142-0c67-e063-6394a90a710f": {
"match": "brand_token",
"title": "EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]",
"spl_version": "1",
"published_date": "2026-04-22"
}
},
"productid": "50090-7719_09d2278c-577b-400f-a781-7be3f5b07834",
"productndc": "50090-7719",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "201806",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG;300MG",
"product_no": "001",
"approval_date": "Oct 7, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG;150MG",
"product_no": "002",
"approval_date": "Mar 3, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "133MG;200MG",
"product_no": "003",
"approval_date": "Mar 3, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "167MG;250MG",
"product_no": "004",
"approval_date": "Mar 3, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"proprietary_name": "Emtricitabine and tenofovir disoproxil fumarate",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA201806",
"marketing_category": "ANDA",
"nonproprietary_name": "Emtricitabine and tenofovir disoproxil fumarate",
"start_marketing_date": "20211007",
"active_numerator_strength": "200; 300"
}Related drugs
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