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United States · US · US:0378-5440_d9a4185e-43fa-4aeb-9b0f-8db01b166038
Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate
Orange BookUNIISPLATC J05AF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ05AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11037854409330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5440-93)
Annotations
UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
A208452
AB
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": {
"7193c90e-456c-4cfb-8181-65a1618dae51": {
"match": "brand_token",
"title": "EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [LAURUS LABS LIMITED]",
"spl_version": "1",
"published_date": "2026-03-06"
}
},
"productid": "0378-5440_d9a4185e-43fa-4aeb-9b0f-8db01b166038",
"productndc": "0378-5440",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208452",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG;EQ 25MG BASE;300MG",
"product_no": "001",
"approval_date": "May 20, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE",
"proprietary_name": "Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA208452",
"marketing_category": "ANDA",
"nonproprietary_name": "Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate",
"start_marketing_date": "20250527",
"active_numerator_strength": "200; 25; 300"
}Related drugs
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