NDC 46708-204

ITRACONAZOLE

Itraconazole

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

Product ID46708-204_c3f9ac0d-8e81-4f27-875e-9e8bafd70d99
NDC46708-204
Product TypeHuman Prescription Drug
Proprietary NameITRACONAZOLE
Generic NameItraconazole
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-12-16
Marketing CategoryANDA / ANDA
Application NumberANDA206741
Labeler NameAlembic Pharmaceuticals Limited
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
Listing Certified Through2020-12-31

Packaging

NDC 46708-204-04

28 CAPSULE in 1 CARTON (46708-204-04)
Marketing Start Date2016-12-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-204-10 [46708020410]

ITRACONAZOLE CAPSULE
Marketing CategoryANDA
Application NumberANDA206741
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-16

NDC 46708-204-90 [46708020490]

ITRACONAZOLE CAPSULE
Marketing CategoryANDA
Application NumberANDA206741
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-16

NDC 46708-204-30 [46708020430]

ITRACONAZOLE CAPSULE
Marketing CategoryANDA
Application NumberANDA206741
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-16

NDC 46708-204-04 [46708020404]

ITRACONAZOLE CAPSULE
Marketing CategoryANDA
Application NumberANDA206741
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-16

NDC 46708-204-71 [46708020471]

ITRACONAZOLE CAPSULE
Marketing CategoryANDA
Application NumberANDA206741
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-16

Drug Details

Active Ingredients

IngredientStrength
ITRACONAZOLE100 mg/1

OpenFDA Data

SPL SET ID:f9d8b5a7-435f-40e6-8596-5f2376b92c74
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311204
  • UPC Code
  • 0346708204303
  • 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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