EXTENDED PHENYTOIN SODIUM

Product NDC
64725-0720
11-digit product format
647250720
Labeler code
64725
Product ID
64725-0720_ec4681c5-a369-4557-af26-fc5695772023
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EXTENDED PHENYTOIN SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA040732
Marketing category
ANDA
Marketing start
2008-01-30
Marketing end
0000-00-00
Substance
PHENYTOIN SODIUM
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
64725-0720-12019-11-27C16284748780-19855e2a2-419a-60a7-e053-dbdaa90a05bdExtended Phenytoin Sodium Capsules USP, 100 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0720-1EXTENDED PHENYTOIN SODIUM100 in 1 BOTTLECAPSULE1002

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0720EXTENDED PHENYTOIN SODIUM CAPSULE [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140829_73273069-249a-423e-b634-a73af6632ba3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN73273069-249a-423e-b634-a73af6632ba32
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD73273069-249a-423e-b634-a73af6632ba32
855671DPH sodium 100 MG Extended Release Oral CapsuleSY73273069-249a-423e-b634-a73af6632ba32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0720-164725072001100 in 1 BOTTLEHistorical