FDA.reportPublic FDA data

topiramate

Product NDC
70518-2104
11-digit product format
705182104
Labeler code
70518
Product ID
70518-2104_50af5f6e-de0c-b713-e063-6394a90ad307
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078235
Marketing category
ANDA
Marketing start
2019-05-22
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
70518-2104-0topiramate30 in 1 BLISTER PACKTABLET, FILM COATED3019
70518-2104-1topiramate30 in 1 BOXTABLET, FILM COATED3019
70518-2104-2topiramate1 in 1 POUCHTABLET, FILM COATED119
70518-2104-3topiramate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6019
70518-2104-4topiramate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3019
70518-2104-5topiramate100 in 1 BOXTABLET, FILM COATED10019
70518-2104-6topiramate1 in 1 POUCHTABLET, FILM COATED119
70518-2104-7topiramate28 in 1 BLISTER PACKTABLET, FILM COATED2819
70518-2104-8topiramate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9019
70518-2104-9topiramate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2104TOPIRAMATE TABLET, FILM COATED [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 10 package rows20250306_7e0834ee-920b-496f-954d-f9d81c3ba2d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN7e0834ee-920b-496f-954d-f9d81c3ba2d619
199889topiramate 100 MG Oral TabletSCD7e0834ee-920b-496f-954d-f9d81c3ba2d619

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2104-07051821040030 in 1 BLISTER PACKHistorical
70518-2104-17051821040130 POUCH in 1 BOX (70518-2104-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-2104-2) 30 pouch2020-11-120000-00-00NoNoCurrent
70518-2104-2705182104021 in 1 POUCHHistorical
70518-2104-37051821040360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2104-3) 2020-12-220000-00-00NoNoCurrent
70518-2104-47051821040430 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2104-4) 2021-03-290000-00-00NoNoCurrent
70518-2104-570518210405100 POUCH in 1 BOX (70518-2104-5) / 1 TABLET, FILM COATED in 1 POUCH (70518-2104-6) 100 pouch2021-09-150000-00-00NoNoCurrent
70518-2104-6705182104061 in 1 POUCHHistorical
70518-2104-77051821040728 TABLET, FILM COATED in 1 BLISTER PACK (70518-2104-7) 2021-12-220000-00-00NoNoCurrent
70518-2104-87051821040890 in 1 BOTTLE, PLASTICHistorical
70518-2104-970518210409180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2104-9) 2025-07-01NoNoCurrent