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United States · US · US:59651-167_a805c27a-1154-4aac-9af8-bbd755be027f
Emtricitabine and Tenofovir Disoproxil Fumarate
Orange BookUNIISPLATC J05AF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ05AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11596511673030 TABLET, FILM COATED in 1 BOTTLE (59651-167-30)
Annotations
UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
A211640
ABABAB
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": "59651-167_a805c27a-1154-4aac-9af8-bbd755be027f",
"productndc": "59651-167",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211640",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG;150MG",
"product_no": "001",
"approval_date": "Mar 9, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "133MG;200MG",
"product_no": "002",
"approval_date": "Mar 9, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "167MG;250MG",
"product_no": "003",
"approval_date": "Mar 9, 2023"
}
],
"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": "ANDA211640",
"marketing_category": "ANDA",
"nonproprietary_name": "Emtricitabine and Tenofovir Disoproxil Fumarate",
"start_marketing_date": "20230309",
"active_numerator_strength": "167; 250"
}Related drugs
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