Home NDC 66215-201 Zavesca
Product NDC 66215-201
11-digit product format 662150201
Labeler code 66215
Product ID 66215-201_f9cb16ee-d325-b331-e053-6394a90ab08c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name miglustat
Dosage form CAPSULE
Route ORAL
Labeler Actelion Pharmaceuticals US, Inc.
Application NDA021348
Marketing category NDA
Marketing start 2003-07-31
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 Zavesca
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 401938 Internal RxNorm lookup 541070 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 66215-201-15 Zavesca 15 in 1 BLISTER PACK CAPSULE 15 19 66215-201-90 Zavesca 6 in 1 CARTON CAPSULE 6 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded miglustat ACTIVE INGREDIENT ADN3S497AZ ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] 7 miglustat ACTIVE MOIETY ADN3S497AZ ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] 7 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] 7 gelatin INACTIVE INGREDIENT 2G86QN327L ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] 7 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] 7 povidone k30 INACTIVE INGREDIENT U725QWY32X ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] 7 shellac INACTIVE INGREDIENT 46N107B71O ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] 7 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] 7 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66215-201 ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] 19 Current NDC, Legacy NDC, 2 package rows 20230421_817892d1-ee12-4632-85fc-57ccdf16d7b8.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 66215-201-15 66215020115 15 in 1 BLISTER PACK Historical 66215-201-90 66215020190 6 BLISTER PACK in 1 CARTON (66215-201-90) / 15 CAPSULE in 1 BLISTER PACK (66215-201-15) 6 blister pack 2003-07-31 0000-00-00 No No Current