FDA.reportPublic FDA data

Phenytoin Sodium

Product NDC
50268-719
11-digit product format
502680719
Labeler code
50268
Product ID
50268-719_4c253166-859e-cff9-e063-6294a90a7bb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA040684
Marketing category
ANDA
Marketing start
2026-03-03
Substance
PHENYTOIN SODIUM
Active strength
100 mg/1
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
Phenytoin Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4182431BJH
Rxcui855671

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-719-11Phenytoin Sodium1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE11
50268-719-13Phenytoin Sodium30 in 1 CARTONCAPSULE, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-719-11EA - Each50268-7195bd621b4-11cc-4a25-ab1b-67d964b785b312026-04-20
50268-719-13EA - Each50268-71995e21802-cb62-4714-b280-e73f3abbd23512026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN4c2542b8-ac54-e85d-e063-6294a90a759b1
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD4c2542b8-ac54-e85d-e063-6294a90a759b1
855671DPH sodium 100 MG Extended Release Oral CapsuleSY4c2542b8-ac54-e85d-e063-6294a90a759b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-719-11502680719111 in 1 BLISTER PACKHistorical
50268-719-135026807191330 BLISTER PACK in 1 CARTON (50268-719-13) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-719-11) 30 blister pack2026-03-03NoNoCurrent