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United States · US · US:65862-105_a02dd4c8-6159-48b0-a79c-c362f1f4daf9
Efavirenz
Orange BookUNIISPLATC J05AG03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ05AG03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1165862105103 BLISTER PACK in 1 CARTON (65862-105-10) / 10 CAPSULE in 1 BLISTER PACK
- ndc11658621053030 CAPSULE in 1 BOTTLE (65862-105-30)
Annotations
UNII (FDA Substance ID)
JE6H2O27P8
EFAVIRENZ
RxCUI 195085
Orange Book
A078064
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": "65862-105_a02dd4c8-6159-48b0-a79c-c362f1f4daf9",
"productndc": "65862-105",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "078064",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "Dec 15, 2017"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "100MG",
"product_no": "002",
"approval_date": "Dec 15, 2017"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "003",
"approval_date": "Dec 15, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EFAVIRENZ",
"proprietary_name": "Efavirenz",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078064",
"marketing_category": "ANDA",
"nonproprietary_name": "Efavirenz",
"start_marketing_date": "20171215",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J05AG03.
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