Kaletra

Basic Information

Product Name

Kaletra

FDA Product Code

0074-0522

Regulatory Information

NDC Product Code

0074-0522

Application Number

NDA021906

Marketing Category

C73594

Effective Date

July 10, 2023

Territorial Authority

USA

FDA Title

These 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, for oral use KALETRA (lopinavir and ritonavir) oral solution Initial U.S. Approval: 2000

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1699

Active Ingredients

LOPINAVIR

Quantity: 100 mg in 1 1

Code: 2494G1JF75

Class Code: ACTIB

RITONAVIR

Quantity: 25 mg in 1 1

Code: O3J8G9O825

Class Code: ACTIB

SORBITAN MONOLAURATE

Code: 6W9PS8B71J

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL 3350

Code: G2M7P15E5P

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

COPOVIDONE K25-31

Code: D9C330MD8B

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

Active Moieties

LOPINAVIR

Code: 2494G1JF75

RITONAVIR

Code: O3J8G9O825

Basic Information

Regulatory Information

Company Information

Active Ingredients

SORBITAN MONOLAURATE

TALC

SODIUM STEARYL FUMARATE

TITANIUM DIOXIDE

POLYETHYLENE GLYCOL 3350

FERRIC OXIDE YELLOW

COPOVIDONE K25-31

SILICON DIOXIDE

POLYVINYL ALCOHOL, UNSPECIFIED

Active Moieties

LOPINAVIR

RITONAVIR