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 4 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
CEREBYXFOSPHENYTOIN SODIUMPfizer Laboratories Div Pfizer Incd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a2025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1670200
rxcui: 1670195
unii: 7VLR55452Z
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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