FDA.reportPublic FDA data

Fosphenytoin Sodium

Product NDC
0143-9788
11-digit product format
001439788
Labeler code
0143
Product ID
0143-9788_6b56fe59-9fb1-410b-b57c-7ada1662136a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosphenytoin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
West-Ward Pharmaceuticals Corp
Application
ANDA078765
Marketing category
ANDA
Marketing start
2009-12-02
Substance
FOSPHENYTOIN SODIUM
Active strength
50 mg/mL
Pharmacologic classes
Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fosphenytoin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSPHENYTOIN SODIUM50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7VLR55452Z
Rxcui1670195, 1670200

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9788-01Fosphenytoin Sodium2 mL in 1 VIALINJECTION, SOLUTION210
0143-9788-25Fosphenytoin Sodium25 in 1 PACKAGEINJECTION, SOLUTION2510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9788-01ML - Milliliter0143-9788219fe9fd-51fc-4709-a9c4-887d9fbca69612018-07-03
0143-9788-25ML - Milliliter0143-9788bb50d638-6b10-4d80-b5bf-916e4c56a8d512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSPHENYTOIN SODIUMACTIVE INGREDIENT7VLR55452ZFOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7
PHENYTOINACTIVE MOIETY6158TKW0C5FOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VFOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7
WATERINACTIVE INGREDIENT059QF0KO0RFOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9788FOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICALS CORP]10Current NDC, Legacy NDC, 2 package rows20180108_c92df63b-5140-4213-8d43-8327ff6230b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670200fosphenytoin sodium 150 MG (as PE 100 MG) per 2 ML InjectionPSNc92df63b-5140-4213-8d43-8327ff6230b710
1670195fosphenytoin sodium 750 MG (as PE 500 MG) per 10 ML InjectionPSNc92df63b-5140-4213-8d43-8327ff6230b710
167019510 ML fosphenytoin sodium 75 MG/ML InjectionSCDc92df63b-5140-4213-8d43-8327ff6230b710
16702002 ML fosphenytoin sodium 75 MG/ML InjectionSCDc92df63b-5140-4213-8d43-8327ff6230b710
1670200fosphenytoin sodium 100 MG PE per 2 ML InjectionSYc92df63b-5140-4213-8d43-8327ff6230b710
1670195fosphenytoin sodium 500 MG PE per 10 ML InjectionSYc92df63b-5140-4213-8d43-8327ff6230b710
1670200fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 100 MG per 2 ML) InjectionSYc92df63b-5140-4213-8d43-8327ff6230b710
1670195fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 500 MG per 10 ML) InjectionSYc92df63b-5140-4213-8d43-8327ff6230b710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9788-01001439788012 mL in 1 VIAL2 mlHistorical
0143-9788-250014397882525 VIAL in 1 PACKAGE (0143-9788-25) / 2 mL in 1 VIAL (0143-9788-01) 25 vial2009-12-020000-00-00NoNoCurrent