NDC 0245-0556-89 - VIGADRONE

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
0245-0556
Requested NDC
0245-0556-89
Package NDCs from labels
0245-0556-89, 0245-0556-50
Manufacturer
Upsher-Smith Laboratories, LLC
Effective date
2026-06-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VIGADRONE - Upsher-Smith Laboratories, LLCUpsher-Smith Laboratories, LLC2026-06-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0245-0556-50VIGADRONE50 in 1 CARTONPOWDER, FOR SOLUTION508
0245-0556-89VIGADRONE10 mL in 1 PACKETPOWDER, FOR SOLUTION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0556VIGADRONE (VIGABATRIN) POWDER, FOR SOLUTION [UPSHER-SMITH LABORATORIES, LLC]7Current NDC, Legacy NDC, 2 package rows20241121_5e5e7554-d0f4-47f7-a434-cc5ca5a9826f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0556-50EA - Each0245-05568a6bbf50-2294-42b1-8c7c-b5c490f37c5612018-07-03
0245-0556-89EA - Each0245-05569c1bd2de-2c00-4029-a1da-8992b2900ec012018-07-03

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VIGABATRINVIGABATRINCipla USA, Inc.823cc915-0350-4780-85ed-cd1c338e429d2022-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
SABRILVIGABATRINLundbeck Pharmaceuticals LLCa5d389d2-d0e1-4395-a2a2-b552808e7f982021-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
SABRILVIGABATRINLundbeck Pharmaceuticals LLCa88ac1b4-e2c9-45c0-b321-4785902172e32021-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
VigabatrinVIGABATRINDr. Reddys Laboratories Inc.,0afdc84c-f8ec-330a-31c9-fac4ed2569312020-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K

Reported adverse events (FAERS/openFDA)#

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