🇺🇸
United States · US · US:0093-5234_c1a1b151-9dea-485b-a42b-3483fb4ef7d7
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
Orange BookUNIISPLATC J05AG
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeJ05AG
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11009352345630 TABLET, FILM COATED in 1 BOTTLE (0093-5234-56)
Annotations
UNII (FDA Substance ID)
JE6H2O27P8
EFAVIRENZ
RxCUI 195085
Orange Book
A091215
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "JE6H2O27P8",
"rxcui": "195085",
"inchikey": "XPOQHMRABVBWPR-ZDUSSCGKSA-N",
"display_name": "EFAVIRENZ",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"ec61f069-632e-4628-b9b1-701d381a1a06": {
"match": "brand_token",
"title": "EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]",
"spl_version": "100",
"published_date": "2025-11-17"
}
},
"productid": "0093-5234_c1a1b151-9dea-485b-a42b-3483fb4ef7d7",
"productndc": "0093-5234",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091215",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG;200MG;300MG",
"product_no": "001",
"approval_date": "Nov 9, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"proprietary_name": "Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA091215",
"marketing_category": "ANDA",
"nonproprietary_name": "Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate",
"start_marketing_date": "20201001",
"active_numerator_strength": "600; 200; 300"
}Related drugs
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- GBEfavirenz 600mg / Emtricitabine 200mg / Tenofovir disoproxil 245mg tabletsTeva UK Ltd
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