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United States · US · US:69097-301_20c14bd6-1106-433b-83ab-c2167b873987
Efavirenz
Orange BookUNIISPLATC J05AG03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeJ05AG03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11690973010230 TABLET, FILM COATED in 1 BOTTLE (69097-301-02)
Annotations
UNII (FDA Substance ID)
JE6H2O27P8
EFAVIRENZ
RxCUI 195085
Orange Book
A204766
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": "69097-301_20c14bd6-1106-433b-83ab-c2167b873987",
"productndc": "69097-301",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204766",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Jun 15, 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": "ANDA204766",
"marketing_category": "ANDA",
"nonproprietary_name": "Efavirenz",
"start_marketing_date": "20180618",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code J05AG03.
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