NDC 51991-959

miglustat

Miglustat

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

Product ID51991-959_88e64165-dd9a-4308-918d-4f91d643f802
NDC51991-959
Product TypeHuman Prescription Drug
Proprietary Namemiglustat
Generic NameMiglustat
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-03-01
Marketing CategoryANDA /
Application NumberANDA209325
Labeler NameBreckenridge Pharmaceutical, Inc.
Substance NameMIGLUSTAT
Active Ingredient Strength100 mg/1
Pharm ClassesGlucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 51991-959-90

90 CAPSULE in 1 BOTTLE (51991-959-90)
Marketing Start Date2022-03-01
NDC Exclude FlagN
Sample Package?N

Drug Details

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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