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United States · US · US:65862-049_f9982eb1-1e15-4fad-99f9-0f9da04fd058
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
- ndc1165862049103 BLISTER PACK in 1 CARTON (65862-049-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11658620493030 TABLET, FILM COATED in 1 BOTTLE (65862-049-30)
Annotations
UNII (FDA Substance ID)
JE6H2O27P8
EFAVIRENZ
RxCUI 195085
Orange Book
A077673
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": "65862-049_f9982eb1-1e15-4fad-99f9-0f9da04fd058",
"productndc": "65862-049",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077673",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Sep 21, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EFAVIRENZ",
"proprietary_name": "Efavirenz",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077673",
"marketing_category": "ANDA",
"nonproprietary_name": "Efavirenz",
"start_marketing_date": "20180921",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code J05AG03.
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