Miglustat

Product NDC: 42799-708
Requested package NDC: 42799-708-15
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	42799-708-15	D	Discontinued by firm		2026-07-31

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
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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	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
2026-08-01 22:54:32	2026-06	A209821-001	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 · 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
42799-708-15	42799070815	1 BLISTER PACK in 1 CARTON (42799-708-15) > 15 CAPSULE in 1 BLISTER PACK	1 blister pack	2020-08-06	0000-00-00	No	No	Current