FDA.reportPublic FDA data

Fosphenytoin Sodium

Product NDC
0641-6137
11-digit product format
006416137
Labeler code
0641
Product ID
0641-6137_d276be92-654c-4912-8dc5-3e148c835523
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosphenytoin Sodium
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA077989
Marketing category
ANDA
Marketing start
2007-08-06
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
0641-6137-01Fosphenytoin Sodium10 mL in 1 VIALINJECTION1022
0641-6137-10Fosphenytoin Sodium10 in 1 CARTONINJECTION1022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6137-01ML - Milliliter0641-6137c8784727-3cef-44c5-a7e0-fb350f6809fc12013-09-04
0641-6137-10ML - Milliliter0641-6137c32209fd-4419-466c-b8e3-cdcbd94c0fe812013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSPHENYTOIN SODIUMACTIVE INGREDIENT7VLR55452ZFOSPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]9
PHENYTOINACTIVE MOIETY6158TKW0C5FOSPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]9
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFOSPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFOSPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]9
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VFOSPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]9
WATERINACTIVE INGREDIENT059QF0KO0RFOSPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6137FOSPHENYTOIN SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.]22Current NDC, Legacy NDC, 2 package rows20240411_519a44e3-8a93-456c-b71c-894513810d45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670200fosphenytoin sodium 150 MG (as PE 100 MG) per 2 ML InjectionPSN519a44e3-8a93-456c-b71c-894513810d4522
1670195fosphenytoin sodium 750 MG (as PE 500 MG) per 10 ML InjectionPSN519a44e3-8a93-456c-b71c-894513810d4522
167019510 ML fosphenytoin sodium 75 MG/ML InjectionSCD519a44e3-8a93-456c-b71c-894513810d4522
16702002 ML fosphenytoin sodium 75 MG/ML InjectionSCD519a44e3-8a93-456c-b71c-894513810d4522
1670200fosphenytoin sodium 100 MG PE per 2 ML InjectionSY519a44e3-8a93-456c-b71c-894513810d4522
1670195fosphenytoin sodium 500 MG PE per 10 ML InjectionSY519a44e3-8a93-456c-b71c-894513810d4522
1670200fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 100 MG per 2 ML) InjectionSY519a44e3-8a93-456c-b71c-894513810d4522
1670195fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 500 MG per 10 ML) InjectionSY519a44e3-8a93-456c-b71c-894513810d4522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6137-010064161370110 mL in 1 VIAL10 mlHistorical
0641-6137-100064161371010 VIAL in 1 CARTON (0641-6137-10) / 10 mL in 1 VIAL (0641-6137-01) 10 vial2007-08-060000-00-00NoNoCurrent