FDA.reportPublic FDA data

PHENYTOIN SODIUM

Product NDC
53002-1501
11-digit product format
530021501
Labeler code
53002
Product ID
53002-1501_5c315d08-f19f-406a-a737-c7ae373fab1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYTOIN SODIUM
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA040621
Marketing category
ANDA
Marketing start
2006-12-12
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
2021-12-31
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
53002-1501-02025-01-30C16284748780-19d75b9d1-1e5d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
53002-1501-32025-01-30C16284748780-19d75b9d1-1e5d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
53002-1501-02023-06-07C16284748780-19d75b9d1-1e5d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
53002-1501-32023-06-07C16284748780-19d75b9d1-1e5d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
53002-1501-02023-01-30C16284748780-19d75b9d1-1e5d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
53002-1501-32023-01-30C16284748780-19d75b9d1-1e5d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
53002-1501-02020-12-15C16284748780-19d75b9d1-1e5d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
53002-1501-32020-12-15C16284748780-19d75b9d1-1e5d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
53002-1501-02020-01-31C16284748780-19d75b9d1-1e5d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
53002-1501-32020-01-31C16284748780-19d75b9d1-1e5d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1501-0PHENYTOIN SODIUM100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1005
53002-1501-3PHENYTOIN SODIUM30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1501PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_7f20cf98-1a63-4eaf-a7ac-fa5d79a045e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN7f20cf98-1a63-4eaf-a7ac-fa5d79a045e05
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD7f20cf98-1a63-4eaf-a7ac-fa5d79a045e05
855671DPH sodium 100 MG Extended Release Oral CapsuleSY7f20cf98-1a63-4eaf-a7ac-fa5d79a045e05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1501-053002150100100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-1501-0) 2017-09-010000-00-00NoNoCurrent
53002-1501-35300215010330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-1501-3) 2017-09-010000-00-00NoNoCurrent