Miglustat

Product NDC: 42799-708
Requested package NDC: 42799-708-01
11-digit product format: 427990708
Labeler code: 42799
Product ID: 42799-708_21af69ea-298f-4c2c-8604-75a612eb85e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Miglustat
Dosage form: CAPSULE
Route: ORAL
Labeler: Edenbridge Pharmaceuticals LLC.
Application: ANDA209821
Marketing category: ANDA
Marketing start: 2020-08-06
Marketing end: 0000-00-00
Substance: MIGLUSTAT
Active strength: 100 mg/1
Pharmacologic classes: Glucosylceramide Synthase Inhibitor [EPC],Glucosylceramide Synthase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42799-708	42799-708-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A209821-001	YARGESA	MIGLUSTAT	100MG	CAPSULE / ORAL	AB		2020-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209821-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209821-001	MIGLUSTAT	100MG	CAPSULE / ORAL	AB	2020-08-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209821-001	YARGESA	100MG	CAPSULE / ORAL	AB	2020-08-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209821-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209821-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209821-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209821-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209821-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209821-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209821-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209821-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209821-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209821-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209821-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209821-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209821-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209821-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209821-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209821-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209821-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209821-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209821-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209821-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209821-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209821-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209821-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209821-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209821-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209821-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209821-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209821-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209821-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209821-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209821-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209821-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209821-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209821-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209821-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209821-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209821-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209821-001	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Yargesa	MIGLUSTAT	Edenbridge Pharmaceuticals LLC.	2b371dfe-e2b0-47fe-b677-a7bde7149f87	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209821 application number: ANDA209821

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ADN3S497AZ	MIGLUSTAT	72599-27-0	MIGLUSTAT

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42799-708-01	42799070801	6 BLISTER PACK in 1 CARTON (42799-708-01) > 15 CAPSULE in 1 BLISTER PACK	6 blister pack	2020-08-06	0000-00-00	No	No	Current