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United States · US · US:0074-0522_a0e519cd-694a-44de-9a89-eac59fce76c9
Kaletra
Orange BookUNIISPLATC J05AR
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAbbVie Inc.
CountryUS (United States)
ATC codeJ05AR
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11007405226060 TABLET, FILM COATED in 1 BOTTLE (0074-0522-60)
Annotations
UNII (FDA Substance ID)
2494G1JF75
LOPINAVIR
RxCUI 195088
Orange Book
N021906
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2494G1JF75",
"rxcui": "195088",
"inchikey": "KJHKTHWMRKYKJE-SUGCFTRWSA-N",
"display_name": "LOPINAVIR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"8290add3-4449-4e58-6c97-8fe1eec972e3": {
"match": "brand_token",
"title": "KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.]",
"spl_version": "1700",
"published_date": "2024-09-23"
}
},
"productid": "0074-0522_a0e519cd-694a-44de-9a89-eac59fce76c9",
"productndc": "0074-0522",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021906",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "200MG;50MG",
"product_no": "001",
"approval_date": "Oct 28, 2005"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "100MG;25MG",
"product_no": "002",
"approval_date": "Nov 9, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LOPINAVIR; RITONAVIR",
"proprietary_name": "Kaletra",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA021906",
"marketing_category": "NDA",
"nonproprietary_name": "Lopinavir and Ritonavir",
"start_marketing_date": "20100618",
"active_numerator_strength": "100; 25"
}Related drugs
Other records sharing ATC code J05AR.
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