FDA.reportPublic FDA data

Phenytoin Sodium

Product NDC
0641-0493
11-digit product format
006410493
Labeler code
0641
Product ID
0641-0493_1b68e42c-ebb1-4798-adba-712a41cd1cf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA084307
Marketing category
ANDA
Marketing start
1975-07-16
Substance
PHENYTOIN 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
Phenytoin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN SODIUM50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4182431BJH
Rxcui1670351, 1670353

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
0641-0493-21Phenytoin Sodium2 mL in 1 VIALINJECTION227
0641-0493-25Phenytoin Sodium25 in 1 CARTONINJECTION2527

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-0493-21ML - Milliliter0641-049346fabe90-3a85-43e9-9f9e-13c22d97a58a12012-07-24
0641-0493-25ML - Milliliter0641-04938c6c9ac8-dbf2-43fc-902c-25466ef25ae112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
WATERINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-0493PHENYTOIN SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.]27Current NDC, Legacy NDC, 2 package rows20240410_035a8d4e-2063-4240-83cb-d7eebcabe301.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670351phenytoin sodium 100 MG in 2 ML InjectionPSN035a8d4e-2063-4240-83cb-d7eebcabe30127
1670353phenytoin sodium 250 MG in 5 ML InjectionPSN035a8d4e-2063-4240-83cb-d7eebcabe30127
16703512 ML phenytoin sodium 50 MG/ML InjectionSCD035a8d4e-2063-4240-83cb-d7eebcabe30127
16703535 ML phenytoin sodium 50 MG/ML InjectionSCD035a8d4e-2063-4240-83cb-d7eebcabe30127
16703512 ML DPH sodium 50 MG/ML InjectionSY035a8d4e-2063-4240-83cb-d7eebcabe30127
16703535 ML DPH sodium 50 MG/ML InjectionSY035a8d4e-2063-4240-83cb-d7eebcabe30127
1670351phenytoin sodium 100 MG per 2 ML InjectionSY035a8d4e-2063-4240-83cb-d7eebcabe30127
1670353phenytoin sodium 250 MG per 5 ML InjectionSY035a8d4e-2063-4240-83cb-d7eebcabe30127
1670351phenytoin sodium 100 MG in 2 ML InjectionPSN7607ddff-2f1c-272c-e053-2991aa0a1ab36
16703512 ML phenytoin sodium 50 MG/ML InjectionSCD7607ddff-2f1c-272c-e053-2991aa0a1ab36
16703512 ML DPH sodium 50 MG/ML InjectionSY7607ddff-2f1c-272c-e053-2991aa0a1ab36
1670351phenytoin sodium 100 MG per 2 ML InjectionSY7607ddff-2f1c-272c-e053-2991aa0a1ab36
1670351phenytoin sodium 100 MG in 2 ML InjectionPSN889dd22c-46f0-48d0-b18e-a3783c5fa6535
16703512 ML phenytoin sodium 50 MG/ML InjectionSCD889dd22c-46f0-48d0-b18e-a3783c5fa6535
16703512 ML DPH sodium 50 MG/ML InjectionSY889dd22c-46f0-48d0-b18e-a3783c5fa6535
1670351phenytoin sodium 100 MG per 2 ML InjectionSY889dd22c-46f0-48d0-b18e-a3783c5fa6535
1670351phenytoin sodium 100 MG in 2 ML InjectionPSN43060ca9-58a7-3371-e063-6294a90a57991
1670351phenytoin sodium 100 MG in 2 ML InjectionPSN0aac9dcd-c4df-84d9-e063-6294a90a03761
16703512 ML phenytoin sodium 50 MG/ML InjectionSCD43060ca9-58a7-3371-e063-6294a90a57991
16703512 ML phenytoin sodium 50 MG/ML InjectionSCD0aac9dcd-c4df-84d9-e063-6294a90a03761
16703512 ML DPH sodium 50 MG/ML InjectionSY43060ca9-58a7-3371-e063-6294a90a57991
16703512 ML DPH sodium 50 MG/ML InjectionSY0aac9dcd-c4df-84d9-e063-6294a90a03761
1670351phenytoin sodium 100 MG per 2 ML InjectionSY43060ca9-58a7-3371-e063-6294a90a57991
1670351phenytoin sodium 100 MG per 2 ML InjectionSY0aac9dcd-c4df-84d9-e063-6294a90a03761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-0493-21006410493212 mL in 1 VIAL2 mlHistorical
0641-0493-250064104932525 VIAL in 1 CARTON (0641-0493-25) / 2 mL in 1 VIAL (0641-0493-21) 25 vial1975-07-160000-00-00NoNoCurrent