Drug Information

Product NDC: 0527-1947

Proprietary Name: Lopinavir-Ritonavir

Non Proprietary Name: Lopinavir-Ritonavir

Active Ingredient(s):
  • 80 mg/mL LOPINAVIR;
  • 20 mg/mL RITONAVIR

Administration Route(s): ORAL

Dosage Form(s): SOLUTION

Pharmacy Class(es):
  • HIV Protease Inhibitors [MoA];
  • Protease Inhibitor [EPC];
  • P-Glycoprotein Inhibitors [MoA];
  • Cytochrome P450 3A Inhibitors [MoA];
  • Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA];
  • HIV Protease Inhibitors [MoA];
  • Cytochrome P450 3A Inhibitor [EPC];
  • Protease Inhibitor [EPC];
  • Cytochrome P450 3A Inhibitors [MoA];
  • Cytochrome P450 2D6 Inhibitors [MoA];
  • Cytochrome P450 2C19 Inducers [MoA];
  • Cytochrome P450 3A Inducers [MoA];
  • P-Glycoprotein Inhibitors [MoA];
  • Breast Cancer Resistance Protein Inhibitors [MoA];
  • Cytochrome P450 3A4 Inhibitors [MoA];
  • Cytochrome P450 1A2 Inducers [MoA];
  • Cytochrome P450 2C9 Inducers [MoA];
  • Cytochrome P450 2B6 Inducers [MoA];
  • UDP Glucuronosyltransferases Inducers [MoA]

Labeler Information

Labeler Name: Lannett Company, Inc.
FDA Application Number: ANDA207407
Marketing Category: ANDA
Start Marketing Date:12/27/2016

Package Information

No. Package Code Package Description Billing Unit
10527-1947-481 BOTTLE, PLASTIC in 1 CARTON (0527-1947-48) > 160 mL in 1 BOTTLE, PLASTICML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0527-1947The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMELopinavir-RitonavirThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMELopinavir-RitonavirThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/27/2016This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA207407This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMELannett Company, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMELOPINAVIR; RITONAVIRThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESHIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],UDP Glucuronosyltransferases Inducers [MoA] 

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This page was last updated on: 2/4/2019