FDA.reportPublic FDA data

NDC 43598-697-11 - 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
43598-697
Requested NDC
43598-697-11
Package NDCs from labels
43598-697-11, 43598-697-50
Manufacturer
Dr. Reddy’s Laboratories Inc., | Dr. Reddy’s Laboratories Limited
Effective date
2024-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vigabatrin - Dr. Reddy’s Laboratories Inc., | Dr. Reddy’s Laboratories LimitedDr. Reddy’s Laboratories Inc., | Dr. Reddy’s Laboratories Limited2024-06-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-697-11Vigabatrin10 mL in 1 PACKETPOWDER, FOR SOLUTION108
43598-697-50Vigabatrin50 in 1 CARTONPOWDER, FOR SOLUTION508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-697VIGABATRIN POWDER, FOR SOLUTION [DR. REDDY’S LABORATORIES INC.,]8Current NDC, Legacy NDC, 2 package rows20240608_f6be436e-46c7-e9ab-0fcf-e8d04dc12b72.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-697-11EA - Each43598-697e83618cd-4502-453c-8709-47489a6c769812019-08-06
43598-697-50EA - Each43598-6979e54bd1e-9d80-4494-83cf-7010a988686e12019-07-02

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 3 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: FZ989GH94E
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
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
VigabatrinVIGABATRINAurobindo Pharma Limitedc97ce40c-1c5a-479d-9188-5ce03cf7e0652025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
VIGADRONEVIGABATRINUpsher-Smith Laboratories, LLC01f7f049-78c2-47c2-a66e-ec662ba48a982024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
VigabatrinVIGABATRINActavis Pharma, Inc.8dc7bd15-2636-4d58-b651-dd117ca43dbd2024-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
VigabatrinVIGABATRINDr. Reddys Laboratories Inc.,f6be436e-46c7-e9ab-0fcf-e8d04dc12b722024-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211481
ndc (package): 43598-697-50
ndc (package): 43598-697-11
ndc (product): 43598-697
ndc11 (package): 43598069711
rxcui: 250820
spl id: 108f12cf-4bfc-4406-1d50-d57e656f6c8c
spl set id: f6be436e-46c7-e9ab-0fcf-e8d04dc12b72
unii: GR120KRT6K
vigabatrin for oral solutionVIGABATRINCamber Pharmaceuticals, Inc.bda491b6-47ba-400b-9816-b6d15c6e26832024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
vigabatrinVIGABATRINZydus Pharmaceuticals (USA) Inc.6d3fc853-1b2d-47ad-a4f2-f11505601bc22024-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 250820
unii: GR120KRT6K

Reported adverse events (FAERS/openFDA)#

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