FDA.reportPublic FDA data

Topiramate

Product NDC
70518-2955
11-digit product format
705182955
Labeler code
70518
Product ID
70518-2955_51a3705d-ecf9-8b6a-e063-6394a90a0023
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077627
Marketing category
ANDA
Marketing start
2020-12-02
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2955-02022-02-10C16284748780-1d6a99b39-8035-a426-e053-dadaa90af4c2These 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
70518-2955-02022-01-28C16284748780-1d6a99b39-8035-a426-e053-dadaa90af4c2These 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
70518-2955-0Topiramate30 in 1 BOXTABLET, FILM COATED305
70518-2955-1Topiramate1 in 1 POUCHTABLET, FILM COATED15
70518-2955-2Topiramate30 in 1 BLISTER PACKTABLET, FILM COATED305

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN610d4df7-703f-4070-9adc-3e57ca05a2f15
199889topiramate 100 MG Oral TabletSCD610d4df7-703f-4070-9adc-3e57ca05a2f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2955-07051829550030 POUCH in 1 BOX (70518-2955-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-2955-1) 30 pouch2020-12-020000-00-00NoNoCurrent
70518-2955-1705182955011 in 1 POUCHHistorical
70518-2955-27051829550230 TABLET, FILM COATED in 1 BLISTER PACK (70518-2955-2) 2026-05-12NoNoHistorical