Miglustat

Product NDC
42799-708
11-digit product format
427990708
Labeler code
42799
Product ID
42799-708_21af69ea-298f-4c2c-8604-75a612eb85e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Miglustat
Dosage form
CAPSULE
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA209821
Marketing category
ANDA
Marketing start
2020-08-06
Marketing end
0000-00-00
Substance
MIGLUSTAT
Active strength
100 mg/1
Pharmacologic classes
Glucosylceramide Synthase Inhibitor [EPC],Glucosylceramide Synthase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42799-708-01427990708016 BLISTER PACK in 1 CARTON (42799-708-01) > 15 CAPSULE in 1 BLISTER PACK6 blister pack2020-08-060000-00-00NoNoCurrent
42799-708-15427990708151 BLISTER PACK in 1 CARTON (42799-708-15) > 15 CAPSULE in 1 BLISTER PACK1 blister pack2020-08-060000-00-00NoNoCurrent