kaletra

Generic: lopinavir and ritonavir

Labeler: abbvie inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kaletra
Generic Name lopinavir and ritonavir
Labeler abbvie inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lopinavir 100 mg/1, ritonavir 25 mg/1

Manufacturer
AbbVie Inc.

Identifiers & Regulatory

Product NDC 0074-3008
Product ID 0074-3008_a0e519cd-694a-44de-9a89-eac59fce76c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021906
Listing Expiration 2026-12-31
Marketing Start 2020-04-08

Pharmacologic Class

Established (EPC)
cytochrome p450 3a inhibitor [epc] protease inhibitor [epc]
Mechanism of Action
hiv protease inhibitors [moa] cytochrome p450 3a inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 2c19 inducers [moa] cytochrome p450 3a inducers [moa] p-glycoprotein inhibitors [moa] breast cancer resistance protein inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] cytochrome p450 1a2 inducers [moa] cytochrome p450 2c9 inducers [moa] cytochrome p450 2b6 inducers [moa] udp glucuronosyltransferases inducers [moa] organic anion transporting polypeptide 1b1 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00743008
Hyphenated Format 0074-3008

Supplemental Identifiers

RxCUI
311369 597730 746645 847741 847745 847749
UPC
0300742605212 0300744014128 0300746799221
UNII
O3J8G9O825 2494G1JF75
NUI
N0000000246 N0000191001 N0000175889 N0000190114 N0000182137 N0000185607 N0000190118 N0000185503 N0000190113 N0000182141 N0000191266 N0000185507 N0000187064 N0000190117 N0000190107

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kaletra (source: ndc)
Generic Name lopinavir and ritonavir (source: ndc)
Application Number NDA021906 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (0074-3008-60)
source: ndc

Packages (1)

0074-3008-60 60 TABLET, FILM COATED in 1 BOTTLE (0074-3008-60)

Ingredients (2)

lopinavir (100 mg/1) ritonavir (25 mg/1)

Linked Drug Pages (1)

Kaletra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a0e519cd-694a-44de-9a89-eac59fce76c9", "openfda": {"nui": ["N0000000246", "N0000191001", "N0000175889", "N0000190114", "N0000182137", "N0000185607", "N0000190118", "N0000185503", "N0000190113", "N0000182141", "N0000191266", "N0000185507", "N0000187064", "N0000190117", "N0000190107"], "upc": ["0300742605212", "0300744014128", "0300746799221"], "unii": ["O3J8G9O825", "2494G1JF75"], "rxcui": ["311369", "597730", "746645", "847741", "847745", "847749"], "spl_set_id": ["8290add3-4449-4e58-6c97-8fe1eec972e3"], "pharm_class_epc": ["Cytochrome P450 3A Inhibitor [EPC]", "Protease Inhibitor [EPC]"], "pharm_class_moa": ["HIV Protease Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "UDP Glucuronosyltransferases Inducers [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]"], "manufacturer_name": ["AbbVie Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (0074-3008-60)", "package_ndc": "0074-3008-60", "marketing_start_date": "20240614"}], "brand_name": "Kaletra", "product_id": "0074-3008_a0e519cd-694a-44de-9a89-eac59fce76c9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Cytochrome P450 3A Inhibitor [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "HIV Protease Inhibitors [MoA]", "HIV Protease Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Protease Inhibitor [EPC]", "Protease Inhibitor [EPC]", "UDP Glucuronosyltransferases Inducers [MoA]"], "product_ndc": "0074-3008", "generic_name": "Lopinavir and Ritonavir", "labeler_name": "AbbVie Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kaletra", "active_ingredients": [{"name": "LOPINAVIR", "strength": "100 mg/1"}, {"name": "RITONAVIR", "strength": "25 mg/1"}], "application_number": "NDA021906", "marketing_category": "NDA", "marketing_start_date": "20200408", "listing_expiration_date": "20261231"}