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United States · US · US:33342-013_f1a4251a-e04d-48aa-ae58-44b30df1de0d
Efavirenz
Orange BookUNIISPLATC J05AG03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeJ05AG03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11333420130730 TABLET in 1 BOTTLE (33342-013-07)
Annotations
UNII (FDA Substance ID)
JE6H2O27P8
EFAVIRENZ
RxCUI 195085
Orange Book
A091579
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": {
"92603fa5-7a2c-4bfb-9a70-aadb4fba952c": {
"match": "brand_token",
"title": "EFAVIRENZ TABLET, FILM COATED [CIPLA USA INC.]",
"spl_version": "7",
"published_date": "2024-09-10"
}
},
"productid": "33342-013_f1a4251a-e04d-48aa-ae58-44b30df1de0d",
"productndc": "33342-013",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091579",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "May 10, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EFAVIRENZ",
"proprietary_name": "Efavirenz",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091579",
"marketing_category": "ANDA",
"nonproprietary_name": "Efavirenz",
"start_marketing_date": "20240510",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code J05AG03.
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