FDA.reportPublic FDA data

NDC 63323-403-01 - Fosphenytoin

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
63323-403
Requested NDC
63323-403-01
Package NDCs from labels
63323-403-01, 63323-403-02, 63323-403-04, 63323-403-10
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2023-03-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fosphenytoin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2023-03-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-403-01Fosphenytoin2 mL in 1 VIALINJECTION, SOLUTION214
63323-403-02Fosphenytoin25 in 1 TRAYINJECTION, SOLUTION2514
63323-403-04Fosphenytoin10 mL in 1 VIALINJECTION, SOLUTION1014
63323-403-10Fosphenytoin10 in 1 TRAYINJECTION, SOLUTION1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-403FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]14Current NDC, Legacy NDC, 4 package rows20230519_b60c9c82-e5c7-4e05-98c7-5bbba4af04b2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-403-01ML - Milliliter63323-4031e2e3f93-b845-42e3-819d-5d1d86109c8f12018-08-13
63323-403-02ML - Milliliter63323-403565eaf95-6a7e-44da-950c-687bfa78386512012-07-24
63323-403-04ML - Milliliter63323-4035b6a304c-1805-4fca-a4eb-ab6cfe94563a12018-08-13
63323-403-10ML - Milliliter63323-403f39ee679-eb9c-426d-96bf-f1203af0183812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSPHENYTOIN SODIUMACTIVE INGREDIENT7VLR55452ZFOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
PHENYTOINACTIVE MOIETY6158TKW0C5FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VFOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6

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.