FDA.reportPublic FDA data

Topiramate

Product NDC
53217-315
11-digit product format
532170315
Labeler code
53217
Product ID
53217-315_c2d24d14-c656-4906-a1e4-9d7fee98b3c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076343
Marketing category
ANDA
Marketing start
2014-06-12
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
50 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5b1b0ba-27f8-4d5d-8943-8aed080fdedcProduct name420260306
6c26dd6d-01b5-4a80-b096-b3a6f7ca6077Product name220250623
cb966f54-bbf0-40fb-b581-80c6648d510cProduct name420250623
6e2fb0d7-40d7-e97c-1375-fa022ff20193Product name420250305
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-315-022020-01-31C16284748780-19d75b9cf-d3af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
53217-315-072020-01-31C16284748780-19d75b9cf-d3af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
53217-315-142020-01-31C16284748780-19d75b9cf-d3af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
53217-315-282020-01-31C16284748780-19d75b9cf-d3af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
53217-315-302020-01-31C16284748780-19d75b9cf-d3af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
53217-315-602020-01-31C16284748780-19d75b9cf-d3af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
53217-315-902020-01-31C16284748780-19d75b9cf-d3af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-315-02Topiramate120 in 1 BOTTLETABLET1201
53217-315-07Topiramate7 in 1 BOTTLETABLET71
53217-315-14Topiramate14 in 1 BOTTLETABLET141
53217-315-28Topiramate28 in 1 BOTTLETABLET281
53217-315-30Topiramate30 in 1 BOTTLETABLET301
53217-315-60Topiramate60 in 1 BOTTLETABLET601
53217-315-90Topiramate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-315-02EA - Each53217-315830f3147-01b2-4d5b-8c3f-23ab0aaf275612017-07-07
53217-315-07EA - Each53217-315bd3af062-e325-4234-8ae6-6877d4329d9012017-07-07
53217-315-14EA - Each53217-315e920f897-0df4-420b-b7e3-c5bd0a1f084112017-07-07
53217-315-28EA - Each53217-315205a728f-abb1-46a8-8069-680833bcb29412017-07-07
53217-315-30EA - Each53217-31559a4b6dc-76ce-4dac-a2ae-4b7e5c8f3f9012017-07-07
53217-315-60EA - Each53217-315f040e2a4-9096-4f02-abe5-8c3c7f8f1f7312017-07-07
53217-315-90EA - Each53217-315f333af11-ddfd-4592-9fa5-febaf3e508bc12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-315TOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 7 package rows20170525_299cf1b6-67ca-46ad-913d-5f474ae7b8a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSN299cf1b6-67ca-46ad-913d-5f474ae7b8a01
151226topiramate 50 MG Oral TabletSCD299cf1b6-67ca-46ad-913d-5f474ae7b8a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-315-0253217031502120 in 1 BOTTLEHistorical
53217-315-07532170315077 in 1 BOTTLEHistorical
53217-315-145321703151414 in 1 BOTTLEHistorical
53217-315-285321703152828 in 1 BOTTLEHistorical
53217-315-305321703153030 in 1 BOTTLEHistorical
53217-315-605321703156060 in 1 BOTTLEHistorical
53217-315-905321703159090 in 1 BOTTLEHistorical