NDC 0378-5100

Itraconazole

Itraconazole

Itraconazole is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Itraconazole.

Product ID0378-5100_1b613520-d571-4999-b0ee-a689a334c053
NDC0378-5100
Product TypeHuman Prescription Drug
Proprietary NameItraconazole
Generic NameItraconazole
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2012-07-26
Marketing End Date2023-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA200463
Labeler NameMylan Pharmaceuticals Inc.
Substance NameITRACONAZOLE
Active Ingredient Strength100 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

Packaging

NDC 0378-5100-93

30 CAPSULE in 1 BOTTLE, PLASTIC (0378-5100-93)
Marketing Start Date2012-07-26
Marketing End Date2023-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5100-93 [00378510093]

Itraconazole CAPSULE
Marketing CategoryANDA
Application NumberANDA200463
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-26

Drug Details

Active Ingredients

IngredientStrength
ITRACONAZOLE100 mg/1

OpenFDA Data

SPL SET ID:d343050e-00bb-440c-a24b-7cd18c97e184
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311204
  • 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 "Itraconazole" or generic name "Itraconazole"

    NDCBrand NameGeneric Name
    0378-5100Itraconazoleitraconazole
    10147-0150itraconazoleitraconazole
    10147-1700itraconazoleITRACONAZOLE
    13668-463ItraconazoleItraconazole
    16714-743ItraconazoleItraconazole
    16729-271ItraconazoleITRACONAZOLE
    31722-006ItraconazoleItraconazole
    42543-113ItraconazoleItraconazole
    46708-204ITRACONAZOLEitraconazole
    49884-239ItraconazoleItraconazole
    50268-450ItraconazoleItraconazole
    67877-454ItraconazoleItraconazole
    68151-2718itraconazoleitraconazole
    68382-697itraconazoleitraconazole
    70771-1208itraconazoleitraconazole
    59746-282itraconazoleitraconazole
    60687-299ItraconazoleItraconazole
    62332-204ITRACONAZOLEITRACONAZOLE
    65162-630ItraconazoleItraconazole
    65162-087ItraconazoleItraconazole
    63629-8168ItraconazoleItraconazole
    70518-2872ItraconazoleItraconazole
    0259-1420OnmelITRACONAZOLE
    50458-290SPORANOXITRACONAZOLE
    50458-295SPORANOXitraconazole
    51862-462TolsuraItraconazole

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