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NDC 43975-0310-83 MIGLUSTAT 100 mg/1 Details

MIGLUSTAT 100 mg/1

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.

MedlinePlus Drug Summary

Miglustat is used to treat Gaucher disease type 1 (a condition in which a certain fatty substance is not broken down normally in the body and instead builds up in some organs and causes liver, spleen, bone, and blood problems). Miglustat is in a class of medications called enzyme inhibitors. It works by preventing the body from producing the fatty substance so that less of it will build up in the body and cause symptoms.

Related Packages: 43975-0310-83
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Miglustat

Product Information

NDC	43975-0310
Product ID	43975-310_24d74b6d-77d6-4804-a0f4-7b936ca7e4dc
Associated GPIs	82700070000120
GCN Sequence Number	051970
GCN Sequence Number Description	miglustat CAPSULE 100 MG ORAL
HIC3	Z1G
HIC3 Description	GLUCOSYLCERAMIDE SYNTHASE (GCS) INHIBITOR
GCN	19453
HICL Sequence Number	025098
HICL Sequence Number Description	MIGLUSTAT
Brand/Generic	Generic
Proprietary Name	MIGLUSTAT
Proprietary Name Suffix	n/a
Non-Proprietary Name	MIGLUSTAT
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	MIGLUSTAT
Labeler Name	ANI Pharmaceuticals, Inc.
Pharmaceutical Class	Glucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208342
Listing Certified Through	2024-12-31

Package

NDC 43975-0310-83 (43975031083)

Pricing Information	N/A
NDC Package Code	43975-310-83
Billing NDC	43975031083
Package	6 BLISTER PACK in 1 CARTON (43975-310-83) / 15 CAPSULE in 1 BLISTER PACK (43975-310-08)
Marketing Start Date	2018-04-17
NDC Exclude Flag	N