FDA.reportPublic FDA data

Miglustat

Product NDC
68475-204
11-digit product format
684750204
Labeler code
68475
Product ID
68475-204_94491d95-3cdd-45cd-b94c-a0d4982618cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Miglustat
Dosage form
CAPSULE
Route
ORAL
Labeler
Navinta LLC
Application
ANDA219111
Marketing category
ANDA
Marketing start
2025-05-07
Substance
MIGLUSTAT
Active strength
100 mg/1
Pharmacologic classes
Enzyme Stabilizer [EPC], Enzyme Stabilizers [MoA], Glucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A219111-001MIGLUSTATMIGLUSTAT100MGCAPSULE / ORALAB2025-03-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A219111-001AB

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
2026-02-19 14:30 UTC2026-02A219111-001MIGLUSTAT100MGCAPSULE / ORALAB2025-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219111-001MIGLUSTAT100MGCAPSULE / ORALAB2025-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A219111-001MIGLUSTAT100MGCAPSULE / ORALAB2025-03-146a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219111-001MIGLUSTAT100MGCAPSULE / ORALAB2025-03-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219111-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219111-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219111-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219111-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Miglustat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIGLUSTAT100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ADN3S497AZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
401938Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa9a3ab6-2376-4b52-9e54-15dc87f25260Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0eebf05-be5a-d3ca-e08a-9a2cbb283463Product name520251215
2ccab114-179c-4e54-a671-4f4c19735e2aProduct name120250625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68475-204-01Miglustat15 in 1 BLISTER PACKCAPSULE153
68475-204-02Miglustat6 in 1 CARTONCAPSULE63
68475-204-03Miglustat21 in 1 BLISTER PACKCAPSULE213
68475-204-04Miglustat4 in 1 CARTONCAPSULE43

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MiglustatMIGLUSTATNavinta LLCaa9a3ab6-2376-4b52-9e54-15dc87f252602025-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219111
application number: ANDA219111
ndc (product): 68475-204
MiglustatMIGLUSTATZydus Pharmaceuticals USA Inc.b54cc8a0-2284-44c3-a8fa-d8aaa87a67c62025-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219111
application number: ANDA219111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
401938migLUstat 100 MG Oral CapsulePSNaa9a3ab6-2376-4b52-9e54-15dc87f252603
401938miglustat 100 MG Oral CapsuleSCDaa9a3ab6-2376-4b52-9e54-15dc87f252603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68475-204-016847502040115 in 1 BLISTER PACKHistorical
68475-204-02684750204026 BLISTER PACK in 1 CARTON (68475-204-02) / 15 CAPSULE in 1 BLISTER PACK (68475-204-01) 6 blister pack2025-05-07NoNoCurrent
68475-204-036847502040321 in 1 BLISTER PACKHistorical
68475-204-04684750204044 BLISTER PACK in 1 CARTON (68475-204-04) / 21 CAPSULE in 1 BLISTER PACK (68475-204-03) 4 blister pack2025-12-23NoNoCurrent