FDA.reportPublic FDA data

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#

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42799-70942799-709-01DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209821-001YARGESAMIGLUSTAT100MGCAPSULE / ORALAB2020-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209821-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209821-001YARGESA100MGCAPSULE / ORALAB2020-08-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209821-001AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YargesaMIGLUSTATEdenbridge Pharmaceuticals LLC.2b371dfe-e2b0-47fe-b677-a7bde7149f872025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209821
application number: ANDA209821
ndc (product): 42799-709

Additional Listing Data#

Finished product
Yes
Brand name base
Yargesa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIGLUSTAT100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ADN3S497AZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
401938Internal RxNorm lookup
2642350Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b371dfe-e2b0-47fe-b677-a7bde7149f87Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0eebf05-be5a-d3ca-e08a-9a2cbb283463Product name520251215
2ccab114-179c-4e54-a671-4f4c19735e2aProduct name120250625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42799-709-01Yargesa6 in 1 CARTONCAPSULE65
42799-709-01Yargesa15 in 1 BLISTER PACKCAPSULE155
42799-709-15Yargesa1 in 1 CARTONCAPSULE15
42799-709-15Yargesa15 in 1 BLISTER PACKCAPSULE155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-709YARGESA (MIGLUSTAT) CAPSULE [EDENBRIDGE PHARMACEUTICALS LLC.]3Current NDC, 4 package rows20250418_2b371dfe-e2b0-47fe-b677-a7bde7149f87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
401938migLUstat 100 MG Oral CapsulePSN2b371dfe-e2b0-47fe-b677-a7bde7149f875
2642350YARGESA 100 MG Oral CapsulePSN2b371dfe-e2b0-47fe-b677-a7bde7149f875
2642350miglustat 100 MG Oral Capsule [Yargesa]SBD2b371dfe-e2b0-47fe-b677-a7bde7149f875
401938miglustat 100 MG Oral CapsuleSCD2b371dfe-e2b0-47fe-b677-a7bde7149f875
2642350Yargesa 100 MG Oral CapsuleSY2b371dfe-e2b0-47fe-b677-a7bde7149f875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42799-709-01427990709016 in 1 CARTONHistorical
42799-709-15427990709151 BLISTER PACK in 1 CARTON (42799-709-15) / 15 CAPSULE in 1 BLISTER PACK1 blister pack2023-10-31NoNoCurrent