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 42 .
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021348-001 ZAVESCA 100MG CAPSULE / ORAL AB RLD, RS 2003-07-31 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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
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.
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