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United States · US · US:33342-163_115178c8-5ee2-4d96-820e-ea8264c1ac10
Lopinavir and Ritonavir
Orange BookUNIISPLATC J05AR
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeJ05AR
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11333421630960 TABLET, FILM COATED in 1 BOTTLE (33342-163-09)
Annotations
UNII (FDA Substance ID)
2494G1JF75
LOPINAVIR
RxCUI 195088
Orange Book
A204739
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": {
"115178c8-5ee2-4d96-820e-ea8264c1ac10": {
"match": "brand_token",
"title": "LOPINAVIR AND RITONAVIR TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]",
"spl_version": "1",
"published_date": "2024-08-20"
}
},
"productid": "33342-163_115178c8-5ee2-4d96-820e-ea8264c1ac10",
"productndc": "33342-163",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204739",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG;25MG",
"product_no": "001",
"approval_date": "Jul 25, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG;50MG",
"product_no": "002",
"approval_date": "Jul 25, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LOPINAVIR; RITONAVIR",
"proprietary_name": "Lopinavir and Ritonavir",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA204739",
"marketing_category": "ANDA",
"nonproprietary_name": "Lopinavir and Ritonavir",
"start_marketing_date": "20240725",
"active_numerator_strength": "100; 25"
}Related drugs
Other records sharing ATC code J05AR.
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