FDA.reportPublic FDA data

topiramate

Product NDC
70518-1718
11-digit product format
705181718
Labeler code
70518
Product ID
70518-1718_50ae93f2-7103-297d-e063-6294a90a141e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078235
Marketing category
ANDA
Marketing start
2018-12-07
Substance
TOPIRAMATE
Active strength
25 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
topiramate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui199888

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1718-0topiramate30 in 1 BLISTER PACKTABLET, FILM COATED3020
70518-1718-1topiramate30 in 1 BOXTABLET, FILM COATED3020
70518-1718-2topiramate1 in 1 POUCHTABLET, FILM COATED120
70518-1718-3topiramate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9020
70518-1718-4topiramate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1718TOPIRAMATE TABLET, FILM COATED [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 5 package rows20250227_149d20de-f262-4567-aa97-d4d28a1653cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN149d20de-f262-4567-aa97-d4d28a1653cb20
199888topiramate 25 MG Oral TabletSCD149d20de-f262-4567-aa97-d4d28a1653cb20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1718-07051817180030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1718-0) 2018-12-070000-00-00NoNoCurrent
70518-1718-17051817180130 POUCH in 1 BOX (70518-1718-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-1718-2) 30 pouch2020-02-110000-00-00NoNoCurrent
70518-1718-2705181718021 in 1 POUCHHistorical
70518-1718-37051817180390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1718-3) 2021-05-260000-00-00NoNoCurrent
70518-1718-47051817180460 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1718-4) 2025-07-01NoNoHistorical