NDC 0527-1947

Lopinavir-Ritonavir

Lopinavir-ritonavir

Lopinavir-Ritonavir is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Lopinavir; Ritonavir.

Product ID0527-1947_38d504a6-4379-49db-b7ce-287a0c716eed
NDC0527-1947
Product TypeHuman Prescription Drug
Proprietary NameLopinavir-Ritonavir
Generic NameLopinavir-ritonavir
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2016-12-27
Marketing CategoryANDA / ANDA
Application NumberANDA207407
Labeler NameLannett Company, Inc.
Substance NameLOPINAVIR; RITONAVIR
Active Ingredient Strength80 mg/mL; mg/mL
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]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0527-1947-48

1 BOTTLE, PLASTIC in 1 CARTON (0527-1947-48) > 160 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2016-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-1947-48 [00527194748]

Lopinavir-Ritonavir SOLUTION
Marketing CategoryANDA
Application NumberANDA207407
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-27

Drug Details

Active Ingredients

IngredientStrength
LOPINAVIR80 mg/mL

OpenFDA Data

SPL SET ID:4b1caefa-e6a2-42f3-9194-6dc1dd9e6d85
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311369
  • UPC Code
  • 0305271947482
  • Pharmacological Class

    • 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]

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