Home NDC 10148-201 Miglustat
Product NDC 10148-201
11-digit product format 101480201
Labeler code 10148
Product ID 10148-201_fa2fce30-3172-6e10-e053-6294a90a1b5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name miglustat
Dosage form CAPSULE
Route ORAL
Labeler CoTherix, Inc.
Application NDA021348
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-04-25
Substance MIGLUSTAT
Active strength 100 mg/1
Pharmacologic classes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021348-001 ZAVESCA MIGLUSTAT 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021348-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N021348-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Miglustat
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIGLUSTAT 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ADN3S497AZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 401938 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10148-201-15 Miglustat 15 in 1 BLISTER PACK CAPSULE 15 16 10148-201-90 Miglustat 6 in 1 CARTON CAPSULE 6 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10148-201 MIGLUSTAT CAPSULE [COTHERIX, INC.] 16 Current NDC, Legacy NDC, 2 package rows 20230426_76eb7ac8-e0ee-4409-a4e7-e326c6725836.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10148-201-15 10148020115 15 in 1 BLISTER PACK Historical 10148-201-90 10148020190 6 BLISTER PACK in 1 CARTON (10148-201-90) / 15 CAPSULE in 1 BLISTER PACK (10148-201-15) 6 blister pack 2018-04-25 0000-00-00 No No Current