NDC 70518-0091

Kaletra

Lopinavir And Ritonavir

Kaletra is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Lopinavir; Ritonavir.

Product ID70518-0091_8050ea56-b6aa-0e7a-e053-2a91aa0a3867
NDC70518-0091
Product TypeHuman Prescription Drug
Proprietary NameKaletra
Generic NameLopinavir And Ritonavir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-12-29
Marketing CategoryNDA / NDA
Application NumberNDA021906
Labeler NameREMEDYREPACK INC.
Substance NameLOPINAVIR; RITONAVIR
Active Ingredient Strength200 mg/1; mg/1
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 Through2020-12-31

Packaging

NDC 70518-0091-2

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0091-2)
Marketing Start Date2017-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0091-2 [70518009102]

Kaletra TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021906
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-28

NDC 70518-0091-0 [70518009100]

Kaletra TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021906
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-29
Marketing End Date2020-04-19

NDC 70518-0091-1 [70518009101]

Kaletra TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021906
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-14
Marketing End Date2020-04-19

Drug Details

Active Ingredients

IngredientStrength
LOPINAVIR200 mg/1

OpenFDA Data

SPL SET ID:f34556f4-b4a7-4b2e-9096-5c4557333271
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 847741
  • 597730
  • 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]

    NDC Crossover Matching brand name "Kaletra" or generic name "Lopinavir And Ritonavir"

    NDCBrand NameGeneric Name
    0074-0522KaletraLopinavir and Ritonavir
    0074-1575KaletraLopinavir and Ritonavir
    0074-2605KaletraLopinavir and Ritonavir
    0074-3956KaletraLopinavir and Ritonavir
    0074-6799KaletraLopinavir and Ritonavir
    11819-342KaletraLopinavir and Ritonavir
    21695-362Kaletralopinavir and ritonavir
    53808-0276Kaletralopinavir and ritonavir
    55289-947KaletraLopinavir and Ritonavir
    68258-1972KaletraKaletra
    70518-0091KaletraKaletra
    66336-624KaletraKaletra
    68071-2348KaletraKaletra
    31722-556Lopinavir and ritonavirLopinavir and ritonavir
    31722-603Lopinavir and ritonavirLopinavir and ritonavir
    42385-933Lopinavir and RitonavirLopinavir and Ritonavir
    42385-934Lopinavir and RitonavirLopinavir and Ritonavir

    Trademark Results [Kaletra]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KALETRA
    KALETRA
    75465750 2451327 Live/Registered
    ABBVIE INC.
    1998-04-09

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