FDA.reportPublic FDA data

Topiramate

Product NDC
72789-004
11-digit product format
727890004
Labeler code
72789
Product ID
72789-004_37663bc9-c517-c973-e063-6394a90aed91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090278
Marketing category
ANDA
Marketing start
2014-12-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topiramate
Listing expiration
2026-12-31

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
72789-004-21Topiramate21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2125
72789-004-30Topiramate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3025
72789-004-60Topiramate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-004-21EA - Each72789-0049d4862f4-2baf-43bd-9ef4-a7f78a2a2f4412020-05-08
72789-004-30EA - Each72789-0042dbe5fa6-9af2-4972-b26e-668cf7664cb812019-10-07
72789-004-60EA - Each72789-004a6c3ecdf-0c48-4cb4-bb82-3ddf16b484f212020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-004TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 3 package rows20240125_e846124d-e9e6-42c7-83f1-5df170d3f70b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSNe846124d-e9e6-42c7-83f1-5df170d3f70b25
199889topiramate 100 MG Oral TabletSCDe846124d-e9e6-42c7-83f1-5df170d3f70b25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-004-217278900042121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-21) 2019-08-200000-00-00NoNoCurrent
72789-004-307278900043030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-30) 2019-08-200000-00-00NoNoCurrent
72789-004-607278900046060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-60) 2020-03-170000-00-00NoNoCurrent