FDA.reportPublic FDA data

NDC 68083-461-01 - Fosphenytoin sodium

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
68083-461
Requested NDC
68083-461-01
Package NDCs from labels
68083-461-01, 68083-461-10
Manufacturer
Gland Pharma Limited
Effective date
2023-10-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fosphenytoin sodium - Gland Pharma LimitedGland Pharma Limited2023-10-17Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-461-01Fosphenytoin sodium10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION106
68083-461-10Fosphenytoin sodium10 in 1 CARTONINJECTION, SOLUTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-461FOSPHENYTOIN SODIUM INJECTION, SOLUTION [GLAND PHARMA LIMITED]6Current NDC, 2 package rows20231024_49b08648-6a83-42c7-ae7b-80c29f2534fc.zip

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 11 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Fosphenytoin SodiumFOSPHENYTOIN SODIUMWest-Ward Pharmaceuticals Corpc92df63b-5140-4213-8d43-8327ff6230b72018-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1670200
rxcui: 1670195
unii: 7VLR55452Z
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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