FDA.reportPublic FDA data

Topiramate

Product NDC
72888-229
11-digit product format
728880229
Labeler code
72888
Product ID
72888-229_4e8dd02d-2263-78d0-e063-6294a90a5f0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA216683
Marketing category
ANDA
Marketing start
2025-05-27
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
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
TOPIRAMATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui205315, 205316, 252413

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
72888-229-05Topiramate500 in 1 BOTTLECAPSULE5007
72888-229-12Topiramate120 in 1 BOTTLECAPSULE1207
72888-229-30Topiramate30 in 1 BOTTLECAPSULE307
72888-229-60Topiramate60 in 1 BOTTLECAPSULE607
72888-229-67Topiramate240 in 1 BOTTLECAPSULE2407

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205316topiramate 15 MG Oral CapsulePSN48169bbc-4fb2-4bc4-9bdd-de71bf7722df7
205315topiramate 25 MG Oral CapsulePSN48169bbc-4fb2-4bc4-9bdd-de71bf7722df7
252413topiramate 50 MG Oral CapsulePSN48169bbc-4fb2-4bc4-9bdd-de71bf7722df7
205316topiramate 15 MG Oral CapsuleSCD48169bbc-4fb2-4bc4-9bdd-de71bf7722df7
205315topiramate 25 MG Oral CapsuleSCD48169bbc-4fb2-4bc4-9bdd-de71bf7722df7
252413topiramate 50 MG Oral CapsuleSCD48169bbc-4fb2-4bc4-9bdd-de71bf7722df7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-229-0572888022905500 CAPSULE in 1 BOTTLE (72888-229-05) 500 capsule2025-05-27NoNoCurrent
72888-229-1272888022912120 CAPSULE in 1 BOTTLE (72888-229-12) 120 capsule2025-05-27NoNoCurrent
72888-229-307288802293030 CAPSULE in 1 BOTTLE (72888-229-30) 30 capsule2025-05-27NoNoCurrent
72888-229-607288802296060 CAPSULE in 1 BOTTLE (72888-229-60) 60 capsule2025-05-27NoNoCurrent
72888-229-6772888022967240 CAPSULE in 1 BOTTLE (72888-229-67) 240 capsule2025-05-27NoNoCurrent