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United States · US · US:65862-055_c0f2da5b-9588-4740-8225-8d9d95e82c1f
Lamivudine
Orange BookUNIISPLATC J05AF05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ05AF05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116586205524240 mL in 1 BOTTLE (65862-055-24)
Annotations
UNII (FDA Substance ID)
2T8Q726O95
LAMIVUDINE
RxCUI 68244
Orange Book
A077695
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2T8Q726O95",
"rxcui": "68244",
"inchikey": "JTEGQNOMFQHVDC-NKWVEPMBSA-N",
"display_name": "LAMIVUDINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6fd4d6b9-65ea-4988-8d6f-dd220ec5052d": {
"match": "brand_token",
"title": "LAMIVUDINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]",
"spl_version": "5",
"published_date": "2026-03-20"
}
},
"productid": "65862-055_c0f2da5b-9588-4740-8225-8d9d95e82c1f",
"productndc": "65862-055",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "077695",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Nov 21, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LAMIVUDINE",
"proprietary_name": "Lamivudine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA077695",
"marketing_category": "ANDA",
"nonproprietary_name": "Lamivudine",
"start_marketing_date": "20161121",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code J05AF05.
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