FDA.reportPublic FDA data

NDC 59651-366-07 - Vigabatrin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
59651-366
Requested NDC
59651-366-07
Package NDCs from labels
59651-366-07, 59651-366-50
Manufacturer
Aurobindo Pharma Limited | APL HEALTHCARE LIMITED
Effective date
2025-07-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vigabatrin - Aurobindo Pharma Limited | APL HEALTHCARE LIMITEDAurobindo Pharma Limited | APL HEALTHCARE LIMITED2025-07-15Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-366-07Vigabatrin1 in 1 PACKETPOWDER, FOR SOLUTION15
59651-366-50Vigabatrin50 in 1 CARTONPOWDER, FOR SOLUTION505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-366VIGABATRIN POWDER, FOR SOLUTION [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 2 package rows20240121_c97ce40c-1c5a-479d-9188-5ce03cf7e065.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-366-50EA - Each59651-366d80afb29-f533-4d96-be90-037fd6802afb12022-04-06

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VigabatrinVIGABATRINEdenbridge Pharmaceuticals LLC.93ba3894-fd97-4432-9f2d-e7050371e91f2026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
VIGADRONEVIGABATRINUpsher-Smith Laboratories, LLC5e5e7554-d0f4-47f7-a434-cc5ca5a9826f2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
VigabatrinVIGABATRINNovadoz Pharmaceuticals LLC082d818a-4f4e-4675-98c6-91db0294e63c2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
vigabatrinVIGABATRINCarnegie Pharmaceuticals LLC8406bd5a-8887-4579-a11e-5ab449c589632026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
VIGABATRINVIGABATRINPar Health USA, LLCe7cbc0a5-8c28-4451-9176-b608e228ba662026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
vigabatrinVIGABATRINZydus Lifesciences Limitedcd5ebc7a-8d5b-46b4-ad9b-e4a25fa3e26c2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
vigabatrinVIGABATRINZydus Lifesciences Limitede9c99000-fc0c-4083-b620-ba9ac821f8ac2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
VIGAFYDEVIGABATRINUpsher-Smith Laboratories, LLC8d3d6316-33ab-41e8-9485-4495c218be562025-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
VigabatrinVIGABATRINAurobindo Pharma Limitedc97ce40c-1c5a-479d-9188-5ce03cf7e0652025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213899
ndc (package): 59651-366-07
ndc (package): 59651-366-50
ndc (product): 59651-366
ndc11 (package): 59651036607
rxcui: 250820
spl id: 7fa314e2-0506-4061-9058-435a3b5df40d
spl set id: c97ce40c-1c5a-479d-9188-5ce03cf7e065
unii: GR120KRT6K
VIGADRONEVIGABATRINUpsher-Smith Laboratories, LLC01f7f049-78c2-47c2-a66e-ec662ba48a982024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
VigabatrinVIGABATRINActavis Pharma, Inc.8dc7bd15-2636-4d58-b651-dd117ca43dbd2024-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
VigabatrinVIGABATRINDr. Reddys Laboratories Inc.,f6be436e-46c7-e9ab-0fcf-e8d04dc12b722024-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
vigabatrin for oral solutionVIGABATRINCamber Pharmaceuticals, Inc.bda491b6-47ba-400b-9816-b6d15c6e26832024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
vigabatrinVIGABATRINZydus Pharmaceuticals (USA) Inc.6d3fc853-1b2d-47ad-a4f2-f11505601bc22024-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
vigabatrinVIGABATRINZydus Pharmaceuticals (USA) Inc.6c0bf4fb-b234-4053-9163-1e8d0142d7182024-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
VigabatrinVIGABATRINAurobindo Pharma Limited4aaea88b-e0fd-45e3-bb02-604bf8ee9b5b2024-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
VigabatrinVIGABATRINAmneal Pharmaceuticals NY LLC9791494f-492b-487a-8211-7747fb57923e2023-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
VigabatrinVIGABATRINAmneal Pharmaceuticals NY LLC5b8fb137-848b-45fd-9107-a6db5a6753602022-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
VIGABATRINVIGABATRINAscend Laboratories, LLCee835fb6-2b2b-40c4-b6d7-0ad0e790cda82022-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
VigabatrinVIGABATRINHikma Pharmaceuticals USA Inc5ed8d293-b7d8-4c66-9c31-8075e6f990922022-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.