FDA.reportPublic FDA data

Kaletra

Product NDC
21695-362
11-digit product format
216950362
Labeler code
21695
Product ID
21695-362_20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lopinavir and ritonavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
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],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],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [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
21695-362-122019-09-24C16284748780-1934fe258-4c0e-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir and ritonavir) Tablet, Film Coated for Oral use KALETRA (lopinavir and ritonavir) Solution for Oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-362-12Kaletra12 in 1 BOTTLETABLET, FILM COATED121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-362-12EA - Each21695-3620ce04b7f-f139-4c8a-aa1b-acd9c77d0f6612012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-362KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110104_20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847741Kaletra 200 MG / 50 MG Oral TabletPSN20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c1
597730lopinavir 200 MG / ritonavir 50 MG Oral TabletPSN20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c1
847741lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra]SBD20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c1
597730lopinavir 200 MG / ritonavir 50 MG Oral TabletSCD20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c1
847741Kaletra 200 MG / 50 MG Oral TabletSY20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-362-122169503621212 in 1 BOTTLEHistorical