🇺🇸
United States · US · US:49502-475_0a09befe-6075-4bef-bd45-0e41082559d8
SYMFI
Orange BookUNIISPLATC J05AG
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeJ05AG
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1149502475931 BOTTLE, PLASTIC in 1 CARTON (49502-475-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
JE6H2O27P8
EFAVIRENZ
RxCUI 195085
Orange Book
N022142
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": {
"81a55dd9-78a8-49c3-88ab-8f5bffafa359": {
"match": "brand_token",
"title": "SYMFI (EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC]",
"spl_version": "6",
"published_date": "2025-02-12"
}
},
"productid": "49502-475_0a09befe-6075-4bef-bd45-0e41082559d8",
"productndc": "49502-475",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "022142",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "600MG;300MG;300MG",
"product_no": "001",
"approval_date": "Mar 22, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
"proprietary_name": "SYMFI",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "NDA022142",
"marketing_category": "NDA",
"nonproprietary_name": "Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate",
"start_marketing_date": "20180425",
"active_numerator_strength": "600; 300; 300"
}Related drugs
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- GBEfavirenz 600mg / Emtricitabine 200mg / Tenofovir disoproxil 245mg tabletsTeva UK Ltd
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