FDA.reportPublic FDA data

miglustat

Product NDC
51991-959
Requested package NDC
51991-959-90
11-digit product format
519910959
Labeler code
51991
Product ID
51991-959_88e64165-dd9a-4308-918d-4f91d643f802
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Miglustat
Dosage form
CAPSULE
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA209325
Marketing category
ANDA
Marketing start
2022-03-01
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51991-95951991-959-90DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209325-001MIGLUSTATMIGLUSTAT100MGCAPSULE / ORAL2022-02-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209325-001MIGLUSTAT100MGCAPSULE / ORAL2022-02-03a50c72e98297…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-959-905199109599090 CAPSULE in 1 BOTTLE (51991-959-90) 90 capsule2022-03-010000-00-00NoNoCurrent