FDA.reportPublic FDA data

Kaletra

Product NDC
68258-1972
11-digit product format
682581972
Labeler code
68258
Product ID
68258-1972_dbcafc5a-44f8-4f8f-92ed-ed6c3b466f6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lopinavir and Ritonavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
NDA021906
Marketing category
NDA
Marketing start
2010-06-18
Marketing end
0000-00-00
Substance
LOPINAVIR; RITONAVIR
Active strength
200 mg/1; mg/1
Pharmacologic classes
HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],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]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d2364f5-8b1e-7c9a-4518-7b359d95fa50Product name220250116
00d976a9-a12a-db3d-ac4e-27498af714cfProduct name520250115
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
7a5f5ac7-15c0-4d8b-bea4-b3b28cb83a8dProduct name120231023
c8f34825-48cd-e7db-4048-c3be840a9308Product name520230123
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d1ee4fdb-1116-417b-8889-dc05571445b3Product name120160825
f8d26468-b1dc-49d8-a188-8b5d531405efProduct name120150731
0b1bb9d1-e628-4e7c-aada-fd6532257932Product name120150416
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
96979b26-bb9a-43d8-e3a6-d69b9e9f75e5Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-1972-12019-11-27C16284748780-19855d018-e3c0-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir/ritonavir) Tablet, Film Coated for Oral use KALETRA (lopinavir/ritonavir) Solution for Oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-1972-1Kaletra120 in 1 BOTTLETABLET, FILM COATED1201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPINAVIRACTIVE INGREDIENT2494G1JF75KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
RITONAVIRACTIVE INGREDIENTO3J8G9O825KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
LOPINAVIRACTIVE MOIETY2494G1JF75KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
RITONAVIRACTIVE MOIETYO3J8G9O825KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BKALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTKALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PKALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PKALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQKALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HKALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIKALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71JKALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UKALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-1972KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20121011_3fa34341-1dce-4bad-b97e-f466e96a0bbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847741Kaletra 200 MG / 50 MG Oral TabletPSN3fa34341-1dce-4bad-b97e-f466e96a0bbe1
597730lopinavir 200 MG / ritonavir 50 MG Oral TabletPSN3fa34341-1dce-4bad-b97e-f466e96a0bbe1
847741lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra]SBD3fa34341-1dce-4bad-b97e-f466e96a0bbe1
597730lopinavir 200 MG / ritonavir 50 MG Oral TabletSCD3fa34341-1dce-4bad-b97e-f466e96a0bbe1
847741Kaletra 200 MG / 50 MG Oral TabletSY3fa34341-1dce-4bad-b97e-f466e96a0bbe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-1972-168258197201120 in 1 BOTTLEHistorical