NDC 43975-310

MIGLUSTAT

Miglustat

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

Product ID43975-310_29bb4499-7dae-4ad3-bb5f-fe8fd57348b8
NDC43975-310
Product TypeHuman Prescription Drug
Proprietary NameMIGLUSTAT
Generic NameMiglustat
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-04-17
Marketing CategoryANDA / ANDA
Application NumberANDA208342
Labeler NameANI Pharmaceuticals, Inc.
Substance NameMIGLUSTAT
Active Ingredient Strength100 mg/1
Pharm ClassesGlucosylceramide Synthase Inhibitor [EPC],Glucosylceramide Synthase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 43975-310-83

6 BLISTER PACK in 1 CARTON (43975-310-83) > 15 CAPSULE in 1 BLISTER PACK (43975-310-08)
Marketing Start Date2018-04-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43975-310-83 [43975031083]

MIGLUSTAT CAPSULE
Marketing CategoryANDA
Application NumberANDA208342
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-17

NDC 43975-310-08 [43975031008]

MIGLUSTAT CAPSULE
Marketing CategoryANDA
Application NumberANDA208342
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-17

Drug Details

Active Ingredients

IngredientStrength
MIGLUSTAT100 mg/1

OpenFDA Data

SPL SET ID:d746749d-de15-4225-b806-59b0765d25ae
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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