FDA.reportPublic FDA data

Topiramate

Product NDC
50436-1220
11-digit product format
504361220
Labeler code
50436
Product ID
50436-1220_b5743941-974e-47c7-9691-3466841e5cf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA076343
Marketing category
ANDA
Marketing start
2014-06-12
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
25 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
No
Listing certified through
2020-12-31
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
50436-1220-12021-01-29C16284748780-1ba0f9c33-569b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral Use. Initial U.S. Approval: 1996
50436-1220-22021-01-29C16284748780-1ba0f9c33-569b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral Use. Initial U.S. Approval: 1996
50436-1220-32021-01-29C16284748780-1ba0f9c33-569b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral Use. Initial U.S. Approval: 1996
50436-1220-42021-01-29C16284748780-1ba0f9c33-569b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral Use. Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-1220-1Topiramate30 in 1 BOTTLETABLET309
50436-1220-2Topiramate60 in 1 BOTTLETABLET609
50436-1220-3Topiramate90 in 1 BOTTLETABLET909
50436-1220-4Topiramate270 in 1 BOTTLETABLET2709

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-1220-1EA - Each50436-122046ffc841-a485-4454-b298-6fc76cabd48a12017-09-11
50436-1220-2EA - Each50436-1220b66efe4a-61ca-4467-b946-b7589479ad8012017-09-11
50436-1220-3EA - Each50436-12200f8fd4ea-cb9c-493e-b326-f8b4a0f358ba12017-09-11
50436-1220-4EA - Each50436-1220ad8a5739-21e4-4ff5-b132-a06bac1b0c3212017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-1220TOPIRAMATE TABLET [UNIT DOSE SERVICES]9Legacy NDC, 4 package rows20181218_c30881eb-809e-4cc5-9bec-f4eda4b01b56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSNc30881eb-809e-4cc5-9bec-f4eda4b01b569
199888topiramate 25 MG Oral TabletSCDc30881eb-809e-4cc5-9bec-f4eda4b01b569

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-1220-15043612200130 in 1 BOTTLEHistorical
50436-1220-25043612200260 in 1 BOTTLEHistorical
50436-1220-35043612200390 in 1 BOTTLEHistorical
50436-1220-450436122004270 in 1 BOTTLEHistorical