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 1 of 5 · 85 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
VigabatrinVIGABATRINEdenbridge Pharmaceuticals LLC.93ba3894-fd97-4432-9f2d-e7050371e91f2026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
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
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
vigabatrinVIGABATRINCarnegie Pharmaceuticals LLC8406bd5a-8887-4579-a11e-5ab449c589632026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
VIGABATRINVIGABATRINPar Health USA, LLCe7cbc0a5-8c28-4451-9176-b608e228ba662026-01-20Boxed 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.