lopinavir and ritonavir (42385-934)

Drug Facts

Product Profile

Brand Name lopinavir and ritonavir

Generic Name lopinavir and ritonavir

Labeler laurus labs limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

lopinavir 200 mg/1, ritonavir 50 mg/1

Manufacturer

Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-934

Product ID 42385-934_3a3c4164-da47-427d-9f12-6d1f73b0729d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213857

Listing Expiration 2026-12-31

Marketing Start 2022-03-22

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 42385934

Hyphenated Format 42385-934

Supplemental Identifiers

RxCUI

597730 746645

UPC

0342385933604

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 lopinavir and ritonavir (source: ndc)

Generic Name lopinavir and ritonavir (source: ndc)

Application Number ANDA213857 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1
50 mg/1

source: ndc

Packaging

120 TABLET, FILM COATED in 1 BOTTLE (42385-934-12)

source: ndc

Packages (1)

42385-934-12 120 TABLET, FILM COATED in 1 BOTTLE (42385-934-12)

Ingredients (2)

lopinavir (200 mg/1) ritonavir (50 mg/1)

Linked Drug Pages (1)

Lopinavir and Ritonavir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3a3c4164-da47-427d-9f12-6d1f73b0729d", "openfda": {"nui": ["N0000000246", "N0000191001", "N0000175889", "N0000190114", "N0000182137", "N0000185607", "N0000190118", "N0000185503", "N0000190113", "N0000182141", "N0000191266", "N0000185507", "N0000187064", "N0000190117", "N0000190107"], "upc": ["0342385933604"], "unii": ["O3J8G9O825", "2494G1JF75"], "rxcui": ["597730", "746645"], "spl_set_id": ["a7072c60-6dbf-4125-95e7-497c05a9e6a6"], "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": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (42385-934-12)", "package_ndc": "42385-934-12", "marketing_start_date": "20220322"}], "brand_name": "Lopinavir and Ritonavir", "product_id": "42385-934_3a3c4164-da47-427d-9f12-6d1f73b0729d", "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": "42385-934", "generic_name": "Lopinavir and Ritonavir", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lopinavir and Ritonavir", "active_ingredients": [{"name": "LOPINAVIR", "strength": "200 mg/1"}, {"name": "RITONAVIR", "strength": "50 mg/1"}], "application_number": "ANDA213857", "marketing_category": "ANDA", "marketing_start_date": "20220322", "listing_expiration_date": "20261231"}