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 9 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 023C2WHX2V
unii: 059QF0KO0R
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREATINUM, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.2fe2d3c1-1829-4a33-be8e-2bad52546f362023-07-17WarningsExact identifier
unii: QTT17582CB
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FosphenytoinFOSPHENYTOIN SODIUMFresenius Kabi USA, LLCb60c9c82-e5c7-4e05-98c7-5bbba4af04b22023-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078052
ndc (package): 63323-403-10
ndc (package): 63323-403-02
ndc (package): 63323-403-04
ndc (package): 63323-403-01
ndc (product): 63323-403
ndc11 (package): 63323040301
rxcui: 1670200
rxcui: 1670195
spl id: 84385df0-4793-47d2-8e49-5c84668a0ba3
spl set id: b60c9c82-e5c7-4e05-98c7-5bbba4af04b2
unii: 7VLR55452Z
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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