FDA.reportPublic FDA data

Topiramate

Product NDC
10370-368
11-digit product format
103700368
Labeler code
10370
Product ID
10370-368_d2a47bf0-9716-4318-9f8c-bd3d43c0637f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA205976
Marketing category
ANDA
Marketing start
2023-03-24
Substance
TOPIRAMATE
Active strength
200 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
TOPIRAMATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui1437288

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
10370-368-01Topiramate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10014
10370-368-05Topiramate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50014
10370-368-11Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10370-368TOPIRAMATE CAPSULE, EXTENDED RELEASE [ENDO USA, INC.]14Current NDC, 3 package rows20241212_9ac09563-5967-498c-93ae-675a7f4efc48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437288topiramate 200 MG 24HR Extended Release Oral CapsulePSN9ac09563-5967-498c-93ae-675a7f4efc4814
143728824 HR topiramate 200 MG Extended Release Oral CapsuleSCD9ac09563-5967-498c-93ae-675a7f4efc4814
1437288topiramate 200 MG 24 HR Extended Release Oral CapsuleSY9ac09563-5967-498c-93ae-675a7f4efc4814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
10370-368-0110370036801100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-368-01) 2023-03-24NoNoCurrent
10370-368-0510370036805500 in 1 BOTTLEHistorical
10370-368-111037003681130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-368-11) 2023-03-24NoNoCurrent