EXTENDED PHENYTOIN SODIUM

Product NDC
55648-720
11-digit product format
556480720
Labeler code
55648
Product ID
55648-720_21c147fd-c3a2-4c0d-b8a0-4370bebc33f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EXTENDED PHENYTOIN SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA040732
Marketing category
ANDA
Marketing start
2008-01-30
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-720-01EXTENDED PHENYTOIN SODIUM100 in 1 BOTTLECAPSULE1003
55648-720-02EXTENDED PHENYTOIN SODIUM1000 in 1 BOTTLECAPSULE10003

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-720EXTENDED PHENYTOIN SODIUM CAPSULE [WOCKHARDT LIMITED]3Legacy NDC, 2 package rows20130225_e54861d7-a4e4-4e47-8229-6e9c2ace21f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSNe54861d7-a4e4-4e47-8229-6e9c2ace21f83
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCDe54861d7-a4e4-4e47-8229-6e9c2ace21f83
855671DPH sodium 100 MG Extended Release Oral CapsuleSYe54861d7-a4e4-4e47-8229-6e9c2ace21f83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-720-0155648072001100 in 1 BOTTLEHistorical
55648-720-02556480720021000 in 1 BOTTLEHistorical