FDA.reportPublic FDA data

Phenytoin Sodium

Product NDC
70518-0107
11-digit product format
705180107
Labeler code
70518
Product ID
70518-0107_522c4ffd-8073-6be5-e063-6294a90ac6c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040684
Marketing category
ANDA
Marketing start
2017-01-06
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
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0107-0Phenytoin Sodium30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0107PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.]18Current NDC, Legacy NDC, 1 package rows20250529_e33ce05d-9c60-4ede-8b13-e8c41a3de25d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSNe33ce05d-9c60-4ede-8b13-e8c41a3de25d21
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCDe33ce05d-9c60-4ede-8b13-e8c41a3de25d21
855671DPH sodium 100 MG Extended Release Oral CapsuleSYe33ce05d-9c60-4ede-8b13-e8c41a3de25d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0107-07051801070030 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-0107-0) 2017-01-060000-00-00NoNoCurrent