NDC 10148-201

Miglustat

Miglustat

Miglustat is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Cotherix, Inc.. The primary component is Miglustat.

Product ID10148-201_45e4aae2-de90-4397-a79f-fe990d9ddfb5
NDC10148-201
Product TypeHuman Prescription Drug
Proprietary NameMiglustat
Generic NameMiglustat
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-04-25
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021348
Labeler NameCoTherix, Inc.
Substance NameMIGLUSTAT
Active Ingredient Strength100 mg/1
Pharm ClassesGlucosylceramide Synthase Inhibitor [EPC],Glucosylceramide Synthase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10148-201-90

6 BLISTER PACK in 1 CARTON (10148-201-90) > 15 CAPSULE in 1 BLISTER PACK (10148-201-15)
Marketing Start Date2018-04-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10148-201-15 [10148020115]

Miglustat CAPSULE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021348
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-25

NDC 10148-201-90 [10148020190]

Miglustat CAPSULE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021348
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-25

Drug Details

Active Ingredients

IngredientStrength
MIGLUSTAT100 mg/1

OpenFDA Data

SPL SET ID:76eb7ac8-e0ee-4409-a4e7-e326c6725836
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 401938
  • Pharmacological Class

    • Glucosylceramide Synthase Inhibitor [EPC]
    • Glucosylceramide Synthase Inhibitors [MoA]

    NDC Crossover Matching brand name "Miglustat" or generic name "Miglustat"

    NDCBrand NameGeneric Name
    10148-201Miglustatmiglustat
    42799-708MiglustatMiglustat
    43975-310MIGLUSTATMIGLUSTAT
    51991-959miglustatMiglustat
    66215-201Zavescamiglustat

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