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 4 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
vigabatrinVIGABATRINZydus Pharmaceuticals (USA) Inc.6c0bf4fb-b234-4053-9163-1e8d0142d7182024-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: FZ989GH94E
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
unii: FZ989GH94E
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
unii: FZ989GH94E
VigabatrinVIGABATRINAurobindo Pharma Limited4aaea88b-e0fd-45e3-bb02-604bf8ee9b5b2024-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GR120KRT6K
Sunmark Eye Drops Advanced Moisturizer/LubricantDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINEStrategic Sourcing Services LLC0daa4e39-0447-44b6-a7d7-370b12bf94512023-12-23WarningsExact identifier
unii: FZ989GH94E
Meijer Artificial TearsPOLYVINYL ALCOHOL, POVIDONEMeijer Distribution, Inc.9feb3eec-a36f-8fc7-e053-2a95a90adcd32023-12-22WarningsExact identifier
unii: FZ989GH94E
Meijer Advanced Redness and Irritation ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea6d7a-a2cd-d26e-e053-2995a90a15f82023-12-22WarningsExact identifier
unii: FZ989GH94E
Walgreens Eye Drops Advanced Relief 15mLDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIWalgreen Company949f5560-fba7-2da8-e053-2995a90a23c22023-12-20WarningsExact identifier
unii: FZ989GH94E
Signature Care Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLBetter Living Brands LLC5d7228ce-f108-4cc2-9aec-8b4548c3a1552023-12-20WarningsExact identifier
unii: FZ989GH94E
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
unii: FZ989GH94E
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
unii: FZ989GH94E
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
unii: FZ989GH94E
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: FZ989GH94E
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
unii: FZ989GH94E
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
unii: FZ989GH94E
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.