FDA.reportPublic FDA data

Lopinavir and Ritonavir

Manufacturer
Mylan Laboratories Limited
Effective date
2019-02-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:35:59

Label at a glance#

ProductLopinavir and Ritonavir
Active ingredientLOPINAVIR, RITONAVIR
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lopinavir and Ritonavir Oral Granules Carton Label
Lopinavir and Ritonavir Oral Granules Carton Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LOPINAVIR Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813
RITONAVIR Pharmacologic Class Indexing7Indexing - Pharmacologic Class20230816

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d2364f5-8b1e-7c9a-4518-7b359d95fa50Product name220250116
00d976a9-a12a-db3d-ac4e-27498af714cfProduct name520250115
7a5f5ac7-15c0-4d8b-bea4-b3b28cb83a8dProduct name120231023
c8f34825-48cd-e7db-4048-c3be840a9308Product name520230123
d1ee4fdb-1116-417b-8889-dc05571445b3Product name120160825
f8d26468-b1dc-49d8-a188-8b5d531405efProduct name120150731
0b1bb9d1-e628-4e7c-aada-fd6532257932Product name120150416
96979b26-bb9a-43d8-e3a6-d69b9e9f75e5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65015-299-502021-03-05C16284748780-1ba0f9c33-5790-a910-e053-dadaa90a0b85842106fb-8dd6-49d8-b32d-dd54f0610488
65015-299-502021-01-29C16284748780-1ba0f9c33-5790-a910-e053-dadaa90a0b85842106fb-8dd6-49d8-b32d-dd54f0610488

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65015-299-49Lopinavir and Ritonavir50 mg in 1 PACKETGRANULE502
65015-299-50Lopinavir and Ritonavir120 in 1 CARTONGRANULE1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65015-299LOPINAVIR AND RITONAVIR GRANULE [MYLAN LABORATORIES LIMITED]22 package rows20210307_842106fb-8dd6-49d8-b32d-dd54f0610488.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65015-29965015-299-49, 65015-299-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LOPINAVIR2494G1JF75ACTIB
RITONAVIRO3J8G9O825ACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
COPOVIDONE K25-31D9C330MD8BIACT
SORBITAN MONOLAURATE6W9PS8B71JIACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
MANNITOL3OWL53L36AIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
VANILLAQ74T35078HIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f7df8e64-bad0-434e-9d66-f69dc9dcaad5842106fb-8dd6-49d8-b32d-dd54f06104882019-02-06Exact identifier
spl id: f7df8e64-bad0-434e-9d66-f69dc9dcaad5
spl set id: 842106fb-8dd6-49d8-b32d-dd54f0610488

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.