Lopinavir and Ritonavir
Approved
Approval ID
842106fb-8dd6-49d8-b32d-dd54f0610488
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2019
Manufacturers
FDA
Mylan Laboratories Limited
DUNS: 650547156
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lopinavir and Ritonavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65015-299
Product Classification
G
Generic Name
Lopinavir and Ritonavir
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 6, 2019
FDA Product Classification
INGREDIENTS (10)
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
LOPINAVIRActive
Quantity: 40 mg in 50 mg
Code: 2494G1JF75
Classification: ACTIB
RITONAVIRActive
Quantity: 10 mg in 50 mg
Code: O3J8G9O825
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SORBITAN MONOLAURATEInactive
Code: 6W9PS8B71J
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
VANILLAInactive
Code: Q74T35078H
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT