FDA.reportPublic FDA data

Phenytoin Sodium

Product NDC
51407-982
11-digit product format
514070982
Labeler code
51407
Product ID
51407-982_50013854-7707-b34d-e063-6294a90abc37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA040684
Marketing category
ANDA
Marketing start
2006-09-05
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
51407-982-01Phenytoin Sodium100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1002
51407-982-10Phenytoin Sodium1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-982PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 2 package rows20250529_36262a4c-33f1-40a5-e063-6394a90ad36a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN3bc82d23-3950-f181-e063-6394a90ad5653
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD3bc82d23-3950-f181-e063-6394a90ad5653
855671DPH sodium 100 MG Extended Release Oral CapsuleSY3bc82d23-3950-f181-e063-6394a90ad5653
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN36262a4c-33f1-40a5-e063-6394a90ad36a2
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD36262a4c-33f1-40a5-e063-6394a90ad36a2
855671DPH sodium 100 MG Extended Release Oral CapsuleSY36262a4c-33f1-40a5-e063-6394a90ad36a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-982-0151407098201100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-982-01) 2025-05-07NoNoCurrent
51407-982-10514070982101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-982-10) 2025-05-07NoNoCurrent