FDA.reportPublic FDA data

Phenytoin Sodium

Product NDC
67544-517
11-digit product format
675440517
Labeler code
67544
Product ID
67544-517_424e2cbc-67e9-494b-88b7-955d522b8632
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenytoin sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040298
Marketing category
ANDA
Marketing start
1999-01-05
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
No
Listing certified through
2020-12-31
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
67544-517-922023-01-30C16284748780-1f386c649-a241-0266-e053-dadaa90a7c1a404bb4d0-dade-4fb7-a85d-d5233d49fd98
67544-517-942023-01-30C16284748780-1f386c649-a241-0266-e053-dadaa90a7c1a404bb4d0-dade-4fb7-a85d-d5233d49fd98

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-517-92Phenytoin Sodium270 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE2702
67544-517-94Phenytoin Sodium360 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE3602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-517-92EA - Each67544-517e8f8fa44-9e85-431e-a824-211f3da8246b12016-11-08
67544-517-94EA - Each67544-517d74a5830-8ce5-429a-89bf-379a722a578512016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-517PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 2 package rows20191224_404bb4d0-dade-4fb7-a85d-d5233d49fd98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN404bb4d0-dade-4fb7-a85d-d5233d49fd982
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD404bb4d0-dade-4fb7-a85d-d5233d49fd982
855671DPH sodium 100 MG Extended Release Oral CapsuleSY404bb4d0-dade-4fb7-a85d-d5233d49fd982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67544-517-9267544051792270 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-517-92) 2015-04-090000-00-00NoNoCurrent
67544-517-9467544051794360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-517-94) 2015-04-090000-00-00NoNoCurrent