FDA.reportPublic FDA data

Phenytoin Sodium

Product NDC
64725-4111
11-digit product format
647254111
Labeler code
64725
Product ID
64725-4111_cb714702-6d2b-4987-8045-3586baf12337
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA040684
Marketing category
ANDA
Marketing start
2006-09-05
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-4111-12019-11-27C16284748780-19855e2a2-3a32-60a7-e053-dbdaa90a05bdExtended Phenytoin Sodium Capsules USP, 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-4111-1Phenytoin Sodium100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phenytoin SodiumACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
PhenytoinACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
SUCROSEINACTIVE INGREDIENTC151H8M554PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-4111PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140901_6bdcf521-e68e-4849-bfe2-3d46f038a364.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN6bdcf521-e68e-4849-bfe2-3d46f038a3642
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD6bdcf521-e68e-4849-bfe2-3d46f038a3642
855671DPH sodium 100 MG Extended Release Oral CapsuleSY6bdcf521-e68e-4849-bfe2-3d46f038a3642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-4111-164725411101100 in 1 BOTTLEHistorical