Lopinavir-Ritonavir

Product NDC
0527-1947
11-digit product format
005271947
Labeler code
0527
Product ID
0527-1947_751545a0-3b8c-4486-821d-94eb6383dc52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lopinavir-Ritonavir
Dosage form
SOLUTION
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA207407
Marketing category
ANDA
Marketing start
2016-12-27
Marketing end
0000-00-00
Substance
LOPINAVIR; RITONAVIR
Active strength
80 mg/mL; mg/mL
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1947-48ML - Milliliter0527-194742028642-cf20-446a-9d07-3137cc8ad0cf12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1947LOPINAVIR-RITONAVIR SOLUTION [LANNETT COMPANY, INC.]18Legacy NDC20220518_4b1caefa-e6a2-42f3-9194-6dc1dd9e6d85.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-1947-48005271947481 BOTTLE, PLASTIC in 1 CARTON (0527-1947-48) > 160 mL in 1 BOTTLE, PLASTIC2016-12-270000-00-00NoNoCurrent