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United States · US · US:42806-659_db290579-c9e1-44be-b03c-ad8a7efe5ce1
Entecavir
Orange BookUNIISPLATC J05AF10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEPIC PHARMA, LLC
CountryUS (United States)
ATC codeJ05AF10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11428066593030 TABLET in 1 BOTTLE, PLASTIC (42806-659-30)
Annotations
UNII (FDA Substance ID)
5968Y6H45M
ENTECAVIR
RxCUI 306266
Orange Book
A212126
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5968Y6H45M",
"rxcui": "306266",
"inchikey": "YXPVEXCTPGULBZ-WQYNNSOESA-N",
"display_name": "ENTECAVIR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"5a1cbf7e-0352-aa3b-080c-222a6423ecd8": {
"match": "brand_token",
"title": "ENTECAVIR TABLET, FILM COATED [AVKARE]",
"spl_version": "13",
"published_date": "2026-05-15"
}
},
"productid": "42806-659_db290579-c9e1-44be-b03c-ad8a7efe5ce1",
"productndc": "42806-659",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212126",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Sep 25, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "Sep 25, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENTECAVIR",
"proprietary_name": "Entecavir",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212126",
"marketing_category": "ANDA",
"nonproprietary_name": "Entecavir",
"start_marketing_date": "20200602",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code J05AF10.
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