LOPINAVIR AND RITONAVIR- lopinavir and ritonavir granule 
Mylan Laboratories Limited

----------

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Lopinavir and Ritonavir Oral Granules Carton Label
LOPINAVIR AND RITONAVIR 
lopinavir and ritonavir granule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65015-299
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPINAVIR (UNII: 2494G1JF75) (LOPINAVIR - UNII:2494G1JF75) LOPINAVIR40 mg  in 50 mg
RITONAVIR (UNII: O3J8G9O825) (RITONAVIR - UNII:O3J8G9O825) RITONAVIR10 mg  in 50 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
VANILLA (UNII: Q74T35078H)  
Product Characteristics
ColorWHITE (white to creamish) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65015-299-50120 in 1 CARTON02/06/2019
1NDC:65015-299-4950 mg in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only02/06/2019
Labeler - Mylan Laboratories Limited (650547156)

Revised: 2/2019
Document Id: 842106fb-8dd6-49d8-b32d-dd54f0610488
Set id: 842106fb-8dd6-49d8-b32d-dd54f0610488
Version: 1
Effective Time: 20190206
 
Mylan Laboratories Limited