NDC 51862-462

Tolsura

Itraconazole

Tolsura is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Mayne Pharma Inc.. The primary component is Itraconazole.

Product ID51862-462_90f7a5fe-772f-4970-bda1-2b3517266ee9
NDC51862-462
Product TypeHuman Prescription Drug
Proprietary NameTolsura
Generic NameItraconazole
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2018-12-11
Marketing CategoryNDA / NDA
Application NumberNDA208901
Labeler NameMayne Pharma Inc.
Substance NameITRACONAZOLE
Active Ingredient Strength65 mg/1
Pharm ClassesAzole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51862-462-08

8 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-08)
Marketing Start Date2018-12-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51862-462-60 [51862046260]

Tolsura CAPSULE, GELATIN COATED
Marketing CategoryNDA
Application NumberNDA208901
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-11

Drug Details

Active Ingredients

IngredientStrength
ITRACONAZOLE65 mg/1

OpenFDA Data

SPL SET ID:306352d1-9d5a-49ad-b72d-893b99546861
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2106642
  • 2106648

    • Pharmacological Class

    • Azole Antifungal [EPC]
    • Azoles [CS]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]
    • Breast Cancer Resistance Protein Inhibitors [MoA]

    NDC Crossover Matching brand name "Tolsura" or generic name "Itraconazole"

    NDCBrand NameGeneric Name
    51862-462TolsuraItraconazole
    0378-5100Itraconazoleitraconazole
    10147-0150itraconazoleitraconazole
    10147-1700itraconazoleITRACONAZOLE
    13668-463ItraconazoleItraconazole
    16714-743ItraconazoleItraconazole
    16729-271ItraconazoleITRACONAZOLE
    31722-006ItraconazoleItraconazole
    42543-113ItraconazoleItraconazole
    46708-204ITRACONAZOLEitraconazole
    49884-239ItraconazoleItraconazole
    50268-450ItraconazoleItraconazole
    0259-1420OnmelITRACONAZOLE
    50458-290SPORANOXITRACONAZOLE
    50458-295SPORANOXitraconazole

    Trademark Results [Tolsura]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TOLSURA
    TOLSURA
    87648980 5710800 Live/Registered
    Mayne Pharma International Pty Ltd
    2017-10-17
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