Label: LOPINAVIR AND RITONAVIR granule
- NDC Code(s): 65015-299-49, 65015-299-50
- Packager: Mylan Laboratories Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated February 6, 2019
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INGREDIENTS AND APPEARANCE
LOPINAVIR AND RITONAVIR
lopinavir and ritonavir granuleProduct 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)