FDA.reportPublic FDA data

Topiramate

Product NDC
10370-365
11-digit product format
103700365
Labeler code
10370
Product ID
10370-365_f7bcb5d1-262e-4d6b-8eb9-50d55a292dfc
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
2023-05-24
Substance
TOPIRAMATE
Active strength
25 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
TOPIRAMATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui1436239, 1437278, 1437283

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10370-365-01Topiramate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10022
10370-365-05Topiramate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50022
10370-365-11Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10370-365TOPIRAMATE CAPSULE, EXTENDED RELEASE [ENDO USA, INC.]22Current NDC, 3 package rows20241212_11e0924b-fbee-4ec4-b1e4-22d7683b21ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437283topiramate 100 MG 24HR Extended Release Oral CapsulePSN11e0924b-fbee-4ec4-b1e4-22d7683b21ee22
1437278topiramate 25 MG 24HR Extended Release Oral CapsulePSN11e0924b-fbee-4ec4-b1e4-22d7683b21ee22
1436239topiramate 50 MG 24HR Extended Release Oral CapsulePSN11e0924b-fbee-4ec4-b1e4-22d7683b21ee22
143728324 HR topiramate 100 MG Extended Release Oral CapsuleSCD11e0924b-fbee-4ec4-b1e4-22d7683b21ee22
143727824 HR topiramate 25 MG Extended Release Oral CapsuleSCD11e0924b-fbee-4ec4-b1e4-22d7683b21ee22
143623924 HR topiramate 50 MG Extended Release Oral CapsuleSCD11e0924b-fbee-4ec4-b1e4-22d7683b21ee22
1437283topiramate 100 MG 24 HR Extended Release Oral CapsuleSY11e0924b-fbee-4ec4-b1e4-22d7683b21ee22
1437278topiramate 25 MG 24 HR Extended Release Oral CapsuleSY11e0924b-fbee-4ec4-b1e4-22d7683b21ee22
1436239topiramate 50 MG 24 HR Extended Release Oral CapsuleSY11e0924b-fbee-4ec4-b1e4-22d7683b21ee22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
10370-365-0110370036501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-365-01) 2023-05-24NoNoCurrent
10370-365-0510370036505500 in 1 BOTTLEHistorical
10370-365-111037003651130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-365-11) 2023-05-24NoNoCurrent