FDA.reportPublic FDA data

Topiramate

Product NDC
70518-1196
11-digit product format
705181196
Labeler code
70518
Product ID
70518-1196_48c0b1e2-203a-d7b2-e063-6394a90a1035
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076343
Marketing category
ANDA
Marketing start
2018-05-15
Substance
TOPIRAMATE
Active strength
100 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
TOPIRAMATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui199889

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1196-0Topiramate30 in 1 BLISTER PACKTABLET3021
70518-1196-1Topiramate30 in 1 BOXTABLET3021
70518-1196-2Topiramate1 in 1 POUCHTABLET121
70518-1196-3Topiramate100 in 1 BOXTABLET10021
70518-1196-4Topiramate1 in 1 POUCHTABLET121
70518-1196-5Topiramate30 in 1 BOTTLE, PLASTICTABLET3021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1196TOPIRAMATE TABLET [REMEDYREPACK INC.]19Current NDC, Legacy NDC, 6 package rows20250522_44095c2b-2e90-45d2-ab45-d0961c41550d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN44095c2b-2e90-45d2-ab45-d0961c41550d21
199889topiramate 100 MG Oral TabletSCD44095c2b-2e90-45d2-ab45-d0961c41550d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1196-07051811960030 in 1 BLISTER PACKHistorical
70518-1196-17051811960130 POUCH in 1 BOX (70518-1196-1) / 1 TABLET in 1 POUCH (70518-1196-2) 30 pouch2019-10-220000-00-00NoNoCurrent
70518-1196-2705181196021 in 1 POUCHHistorical
70518-1196-370518119603100 POUCH in 1 BOX (70518-1196-3) > 1 TABLET in 1 POUCH (70518-1196-4) 100 pouch2021-08-050000-00-00NoNoCurrent
70518-1196-4705181196041 in 1 POUCHHistorical
70518-1196-57051811960530 TABLET in 1 BOTTLE, PLASTIC (70518-1196-5) 30 tablet2025-05-13NoNoHistorical