Extended Phenytoin Sodium

Product NDC
53808-1040
11-digit product format
538081040
Labeler code
53808
Product ID
53808-1040_546554b9-c902-40ad-a025-ebf3534f4272
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA040765
Marketing category
ANDA
Marketing start
2014-01-01
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
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
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
53808-1040-22020-01-31C16284748780-19d75b9d0-39b8-f424-e053-dadaa90a57ceExtended Phenytoin Sodium Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1040-2Extended Phenytoin Sodium60 in 1 BLISTER PACKCAPSULE601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PHENYTOINACTIVE MOIETY6158TKW0C5EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1040EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20141007_295acc10-5c96-437c-946f-112f7e6a09c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN295acc10-5c96-437c-946f-112f7e6a09c81
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD295acc10-5c96-437c-946f-112f7e6a09c81
855671DPH sodium 100 MG Extended Release Oral CapsuleSY295acc10-5c96-437c-946f-112f7e6a09c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-1040-25380810400260 in 1 BLISTER PACKHistorical