FDA.reportPublic FDA data

Fosphenytoin sodium

Product NDC
68083-461
11-digit product format
680830461
Labeler code
68083
Product ID
68083-461_00f57b3c-3819-440e-a928-eeec0fee27aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosphenytoin sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA214926
Marketing category
ANDA
Marketing start
2023-10-13
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
68083-461-01Fosphenytoin sodium10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION106
68083-461-10Fosphenytoin sodium10 in 1 CARTONINJECTION, SOLUTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-461FOSPHENYTOIN SODIUM INJECTION, SOLUTION [GLAND PHARMA LIMITED]6Current NDC, 2 package rows20231024_49b08648-6a83-42c7-ae7b-80c29f2534fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670200fosphenytoin sodium 150 MG (as PE 100 MG) per 2 ML InjectionPSN49b08648-6a83-42c7-ae7b-80c29f2534fc6
1670195fosphenytoin sodium 750 MG (as PE 500 MG) per 10 ML InjectionPSN49b08648-6a83-42c7-ae7b-80c29f2534fc6
167019510 ML fosphenytoin sodium 75 MG/ML InjectionSCD49b08648-6a83-42c7-ae7b-80c29f2534fc6
16702002 ML fosphenytoin sodium 75 MG/ML InjectionSCD49b08648-6a83-42c7-ae7b-80c29f2534fc6
1670200fosphenytoin sodium 100 MG PE per 2 ML InjectionSY49b08648-6a83-42c7-ae7b-80c29f2534fc6
1670195fosphenytoin sodium 500 MG PE per 10 ML InjectionSY49b08648-6a83-42c7-ae7b-80c29f2534fc6
1670200fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 100 MG per 2 ML) InjectionSY49b08648-6a83-42c7-ae7b-80c29f2534fc6
1670195fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 500 MG per 10 ML) InjectionSY49b08648-6a83-42c7-ae7b-80c29f2534fc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-461-016808304610110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
68083-461-106808304611010 VIAL, SINGLE-DOSE in 1 CARTON (68083-461-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-461-01) 2023-10-13NoNoCurrent