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United States · US · US:60687-216_1fbb7ecd-d5f8-a13d-e063-6294a90afc16
Entecavir
Orange BookUNIISPLATC J05AF10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeJ05AF10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11606872162530 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-216-25) / 1 TABLET in 1 BLISTER PACK (60687-216-95)
Annotations
UNII (FDA Substance ID)
5968Y6H45M
ENTECAVIR
RxCUI 306266
Orange Book
A206217
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": "60687-216_1fbb7ecd-d5f8-a13d-e063-6294a90afc16",
"productndc": "60687-216",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "206217",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Aug 26, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "Aug 26, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENTECAVIR",
"proprietary_name": "Entecavir",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206217",
"marketing_category": "ANDA",
"nonproprietary_name": "Entecavir",
"start_marketing_date": "20160812",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code J05AF10.
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