FDA.reportPublic FDA data

MIGLUSTAT

Product NDC
43975-310
11-digit product format
439750310
Labeler code
43975
Product ID
43975-310_589c114d-45f1-423a-8064-846060d968ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIGLUSTAT
Dosage form
CAPSULE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA208342
Marketing category
ANDA
Marketing start
2018-04-17
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

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 Identifiers#

Field, Values table
FieldValues
UniiADN3S497AZ
Rxcui401938

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
43975-310-08MIGLUSTAT15 in 1 BLISTER PACKCAPSULE157
43975-310-83MIGLUSTAT6 in 1 CARTONCAPSULE67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43975-310-08EA - Each43975-3107d64a9c0-f554-4491-b826-3d6a16f7440912018-05-09
43975-310-83EA - Each43975-31006b3776a-7ab3-4fbf-8bc5-6fb1e0098b5612018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43975-310MIGLUSTAT CAPSULE [ANI PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20241215_d746749d-de15-4225-b806-59b0765d25ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
401938migLUstat 100 MG Oral CapsulePSNd746749d-de15-4225-b806-59b0765d25ae7
401938miglustat 100 MG Oral CapsuleSCDd746749d-de15-4225-b806-59b0765d25ae7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43975-310-084397503100815 in 1 BLISTER PACKHistorical
43975-310-83439750310836 BLISTER PACK in 1 CARTON (43975-310-83) / 15 CAPSULE in 1 BLISTER PACK (43975-310-08) 6 blister pack2018-04-170000-00-00NoNoCurrent