LOPINAVIR AND RITONAVIR granule

Lopinavir and Ritonavir by

Drug Labeling and Warnings

Lopinavir and Ritonavir by is a Prescription medication manufactured, distributed, or labeled by Mylan Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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)