Yargesa

Product NDC: 42799-709
11-digit product format: 427990709
Labeler code: 42799
Product ID: 42799-709_462f6c9d-b8f1-3a76-e063-6294a90a2b50
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
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

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	42799-709	42799-709-01	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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Yargesa
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
2642350	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2b371dfe-e2b0-47fe-b677-a7bde7149f87	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a0eebf05-be5a-d3ca-e08a-9a2cbb283463	Product name	5	20251215
2ccab114-179c-4e54-a671-4f4c19735e2a	Product name	1	20250625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42799-709-01	Yargesa	6 in 1 CARTON	CAPSULE	6	5
42799-709-01	Yargesa	15 in 1 BLISTER PACK	CAPSULE	15	5
42799-709-15	Yargesa	1 in 1 CARTON	CAPSULE	1	5
42799-709-15	Yargesa	15 in 1 BLISTER PACK	CAPSULE	15	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42799-709	YARGESA (MIGLUSTAT) CAPSULE [EDENBRIDGE PHARMACEUTICALS LLC.]	3	Current NDC, 4 package rows	20250418_2b371dfe-e2b0-47fe-b677-a7bde7149f87.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 · 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 ndc (product): 42799-709

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
401938	migLUstat 100 MG Oral Capsule	PSN	2b371dfe-e2b0-47fe-b677-a7bde7149f87	5
2642350	YARGESA 100 MG Oral Capsule	PSN	2b371dfe-e2b0-47fe-b677-a7bde7149f87	5
2642350	miglustat 100 MG Oral Capsule [Yargesa]	SBD	2b371dfe-e2b0-47fe-b677-a7bde7149f87	5
401938	miglustat 100 MG Oral Capsule	SCD	2b371dfe-e2b0-47fe-b677-a7bde7149f87	5
2642350	Yargesa 100 MG Oral Capsule	SY	2b371dfe-e2b0-47fe-b677-a7bde7149f87	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42799-709-01	42799070901	6 in 1 CARTON					Historical
42799-709-15	42799070915	1 BLISTER PACK in 1 CARTON (42799-709-15) / 15 CAPSULE in 1 BLISTER PACK	1 blister pack	2023-10-31	No	No	Current