FDA.reportPublic FDA data

Fosphenytoin Sodium

Product NDC
65162-999
11-digit product format
651620999
Labeler code
65162
Product ID
65162-999_757ffbac-e93f-4e0c-b3d2-0d29179b174b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosphenytoin Sodium
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA078476
Marketing category
ANDA
Marketing start
2013-05-17
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65162-999-102020-12-28C16284748780-19d75b9d1-02fd-f424-e053-dadaa90a57ceFosphenytoin Sodium Injection, USP Rx Only
65162-999-102020-01-31C16284748780-19d75b9d1-02fd-f424-e053-dadaa90a57ceFosphenytoin Sodium Injection, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-999-01Fosphenytoin Sodium2 mL in 1 VIALINJECTION216
65162-999-10Fosphenytoin Sodium10 in 1 CARTONINJECTION1016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSPHENYTOIN SODIUMACTIVE INGREDIENT7VLR55452ZFOSPHENYTOIN SODIUM INJECTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]11
PHENYTOINACTIVE MOIETY6158TKW0C5FOSPHENYTOIN SODIUM INJECTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]11
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFOSPHENYTOIN SODIUM INJECTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]11
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFOSPHENYTOIN SODIUM INJECTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]11
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VFOSPHENYTOIN SODIUM INJECTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]11
WATERINACTIVE INGREDIENT059QF0KO0RFOSPHENYTOIN SODIUM INJECTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-999FOSPHENYTOIN SODIUM INJECTION [AMNEAL PHARMACEUTICALS LLC]16Current NDC, Legacy NDC, 2 package rows20241027_87ff8a91-5b37-401c-b75c-dc6efd348761.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670200fosphenytoin sodium 150 MG (as PE 100 MG) per 2 ML InjectionPSN87ff8a91-5b37-401c-b75c-dc6efd34876116
1670195fosphenytoin sodium 750 MG (as PE 500 MG) per 10 ML InjectionPSN87ff8a91-5b37-401c-b75c-dc6efd34876116
167019510 ML fosphenytoin sodium 75 MG/ML InjectionSCD87ff8a91-5b37-401c-b75c-dc6efd34876116
16702002 ML fosphenytoin sodium 75 MG/ML InjectionSCD87ff8a91-5b37-401c-b75c-dc6efd34876116
1670200fosphenytoin sodium 100 MG PE per 2 ML InjectionSY87ff8a91-5b37-401c-b75c-dc6efd34876116
1670195fosphenytoin sodium 500 MG PE per 10 ML InjectionSY87ff8a91-5b37-401c-b75c-dc6efd34876116
1670200fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 100 MG per 2 ML) InjectionSY87ff8a91-5b37-401c-b75c-dc6efd34876116
1670195fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 500 MG per 10 ML) InjectionSY87ff8a91-5b37-401c-b75c-dc6efd34876116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-999-01651620999012 mL in 1 VIAL2 mlHistorical
65162-999-106516209991010 VIAL in 1 CARTON (65162-999-10) / 2 mL in 1 VIAL (65162-999-01) 10 vial2013-05-170000-00-00NoNoCurrent