FDA.reportPublic FDA data

Phenytoin Sodium

Product NDC
53808-0652
11-digit product format
538080652
Labeler code
53808
Product ID
53808-0652_d11a28f5-d648-44c5-955c-02259fa53884
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenytoin sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA040298
Marketing category
ANDA
Marketing start
2009-07-01
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
53808-0652-12019-10-21C16284748780-1956f9ecf-c9f6-621f-e053-dbdaa90a74adcc521263-7ddc-4a79-a3ca-466848e32c23

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0652-1Phenytoin Sodium30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
GELATININACTIVE INGREDIENT2G86QN327LPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SHELLACINACTIVE INGREDIENT46N107B71OPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0652PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20100813_cc521263-7ddc-4a79-a3ca-466848e32c23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSNcc521263-7ddc-4a79-a3ca-466848e32c232
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCDcc521263-7ddc-4a79-a3ca-466848e32c232
855671DPH sodium 100 MG Extended Release Oral CapsuleSYcc521263-7ddc-4a79-a3ca-466848e32c232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0652-15380806520130 in 1 BLISTER PACKHistorical