LOPINAVIR AND RITONAVIR- lopinavir and ritonavir granule
Mylan Laboratories Limited
----------
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
LOPINAVIR AND RITONAVIR
lopinavir and ritonavir granule
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
Item Code (Source)
NDC:65015-299
Route of Administration
ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
LOPINAVIR
(UNII: 2494G1JF75) (LOPINAVIR - UNII:2494G1JF75)
LOPINAVIR
40 mg in 50 mg
RITONAVIR
(UNII: O3J8G9O825) (RITONAVIR - UNII:O3J8G9O825)
RITONAVIR
10 mg in 50 mg
Inactive Ingredients
Ingredient Name
Strength
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
Color
WHITE (white to creamish)
Score
Shape
Size
Flavor
Imprint Code
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:65015-299-50
120 in 1 CARTON
02/06/2019
1
NDC:65015-299-49
50 mg in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
Export only
02/06/2019
Labeler -
Mylan Laboratories Limited (650547156)
Revised: 2/2019
Document Id:
f7df8e64-bad0-434e-9d66-f69dc9dcaad5
34391-3
Set id: 842106fb-8dd6-49d8-b32d-dd54f0610488
Version: 2
Effective Time: 20190206
Mylan Laboratories Limited