FDA.reportPublic FDA data

Fosphenytoin sodium

Product NDC
68462-945
11-digit product format
684620945
Labeler code
68462
Product ID
68462-945_47b1da2e-f5e6-4a4e-8a67-05732a4e20d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosphenytoin sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA214926
Marketing category
ANDA
Marketing start
2025-05-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fosphenytoin sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSPHENYTOIN SODIUM50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7VLR55452Z
Rxcui1670195

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
68462-945-10Fosphenytoin sodium10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION103
68462-945-64Fosphenytoin sodium10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-945-10ML - Milliliter68462-9451642a934-0bf9-4a7d-86df-80083c75fe1912025-08-11
68462-945-64ML - Milliliter68462-9457909edbd-2346-4285-89fa-1f55555504c212025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670195fosphenytoin sodium 750 MG (as PE 500 MG) per 10 ML InjectionPSNbb38bc6a-99c7-4cda-b3f0-37f629d060cf3
167019510 ML fosphenytoin sodium 75 MG/ML InjectionSCDbb38bc6a-99c7-4cda-b3f0-37f629d060cf3
1670195fosphenytoin sodium 500 MG PE per 10 ML InjectionSYbb38bc6a-99c7-4cda-b3f0-37f629d060cf3
1670195fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 500 MG per 10 ML) InjectionSYbb38bc6a-99c7-4cda-b3f0-37f629d060cf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-945-106846209451010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
68462-945-646846209456410 VIAL, SINGLE-DOSE in 1 CARTON (68462-945-64) / 10 mL in 1 VIAL, SINGLE-DOSE (68462-945-10) 2025-05-28NoNoHistorical