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United States · US · US:72189-403_2c4cdf7a-45da-784b-e063-6294a90a82b9
Emtricitabine/TDF
Orange BookUNIISPLATC J05AF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_Rx
CountryUS (United States)
ATC codeJ05AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172189403033 TABLET, FILM COATED in 1 BOTTLE (72189-403-03)
Annotations
UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
A090513
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": {
"ef1a90ca-92bc-3787-e053-2a95a90a58ec": {
"match": "brand_token",
"title": "EMTRICITABINE/TDF TABLET, FILM COATED [DIRECT_RX]",
"spl_version": "4",
"published_date": "2025-01-23"
}
},
"productid": "72189-403_2c4cdf7a-45da-784b-e063-6294a90a82b9",
"productndc": "72189-403",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "090513",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG;300MG",
"product_no": "001",
"approval_date": "Jan 26, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"proprietary_name": "Emtricitabine/TDF",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA090513",
"marketing_category": "ANDA",
"nonproprietary_name": "Emtricitabine/TDF",
"start_marketing_date": "20221205",
"active_numerator_strength": "200; 300"
}Related drugs
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