FDA.reportPublic FDA data

Dilantin

Product NDC
69189-3742
11-digit product format
691893742
Labeler code
69189
Product ID
69189-3742_1a2b8914-4ff8-4e63-9713-6012d9bd8f49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Avera McKennan Hospital
Application
ANDA084349
Marketing category
ANDA
Marketing start
2015-09-14
Marketing end
0000-00-00
Substance
PHENYTOIN SODIUM
Active strength
30 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
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
69189-3742-12020-01-31C16284748780-19d75b9d0-ac2d-f424-e053-dadaa90a57ceDilantin ® (extended phenytoin sodium capsules, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-3742-1Dilantin1 in 1 DOSE PACKCAPSULE, EXTENDED RELEASE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-3742DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20151222_5554a280-0490-4235-9c8c-bea141db6884.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855871Dilantin 30 MG Extended Release Oral CapsulePSN5554a280-0490-4235-9c8c-bea141db68841
855869phenytoin sodium 30 MG Extended Release Oral CapsulePSN5554a280-0490-4235-9c8c-bea141db68841
855871phenytoin sodium 30 MG Extended Release Oral Capsule [Dilantin]SBD5554a280-0490-4235-9c8c-bea141db68841
855869phenytoin sodium 30 MG Extended Release Oral CapsuleSCD5554a280-0490-4235-9c8c-bea141db68841
855871Dilantin 30 MG Extended Release Oral CapsuleSY5554a280-0490-4235-9c8c-bea141db68841
855869DPH sodium 30 MG Extended Release Oral CapsuleSY5554a280-0490-4235-9c8c-bea141db68841
855871DPH sodium 30 MG Extended Release Oral Capsule [Dilantin]SY5554a280-0490-4235-9c8c-bea141db68841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-3742-1691893742011 in 1 DOSE PACKHistorical