FDA.reportPublic FDA data

Topiramate

Product NDC
71335-0548
11-digit product format
713350548
Labeler code
71335
Product ID
71335-0548_bf69b811-09c7-459c-8e24-e1fa04b9f799
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090278
Marketing category
ANDA
Marketing start
2014-12-15
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
Rxcui199888

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
71335-0548-0Topiramate28 in 1 BOTTLETABLET, FILM COATED28105
71335-0548-1Topiramate30 in 1 BOTTLETABLET, FILM COATED30105
71335-0548-2Topiramate60 in 1 BOTTLETABLET, FILM COATED60105
71335-0548-3Topiramate90 in 1 BOTTLETABLET, FILM COATED90105
71335-0548-4Topiramate56 in 1 BOTTLETABLET, FILM COATED56105
71335-0548-5Topiramate84 in 1 BOTTLETABLET, FILM COATED84105
71335-0548-6Topiramate120 in 1 BOTTLETABLET, FILM COATED120105
71335-0548-7Topiramate7 in 1 BOTTLETABLET, FILM COATED7105
71335-0548-8Topiramate14 in 1 BOTTLETABLET, FILM COATED14105
71335-0548-9Topiramate45 in 1 BOTTLETABLET, FILM COATED45105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0548-1EA - Each71335-0548d2e707df-896e-496f-ad1f-378a5fc9b7f712018-04-19
71335-0548-2EA - Each71335-054849a6fd9a-242d-4e5a-83e8-d4eee78500da12018-05-09
71335-0548-3EA - Each71335-0548dea4f1fd-7208-4836-acd4-7984a21ffa8912018-04-19
71335-0548-6EA - Each71335-054876d41872-aa32-4316-938f-dcbefbbefdad12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0548TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 10 package rows20240822_61390be3-7553-4cb5-b5da-7571ed7d4b17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN61390be3-7553-4cb5-b5da-7571ed7d4b17105
199888topiramate 25 MG Oral TabletSCD61390be3-7553-4cb5-b5da-7571ed7d4b17105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0548-07133505480028 TABLET, FILM COATED in 1 BOTTLE (71335-0548-0) 2021-09-150000-00-00NoNoCurrent
71335-0548-17133505480130 TABLET, FILM COATED in 1 BOTTLE (71335-0548-1) 2018-03-190000-00-00NoNoCurrent
71335-0548-27133505480260 TABLET, FILM COATED in 1 BOTTLE (71335-0548-2) 2018-03-050000-00-00NoNoCurrent
71335-0548-37133505480390 TABLET, FILM COATED in 1 BOTTLE (71335-0548-3) 2018-02-150000-00-00NoNoCurrent
71335-0548-47133505480456 TABLET, FILM COATED in 1 BOTTLE (71335-0548-4) 2024-04-030000-00-00NoNoCurrent
71335-0548-57133505480584 TABLET, FILM COATED in 1 BOTTLE (71335-0548-5) 2024-04-030000-00-00NoNoCurrent
71335-0548-671335054806120 TABLET, FILM COATED in 1 BOTTLE (71335-0548-6) 2018-03-010000-00-00NoNoCurrent
71335-0548-7713350548077 TABLET, FILM COATED in 1 BOTTLE (71335-0548-7) 2018-04-230000-00-00NoNoCurrent
71335-0548-87133505480814 TABLET, FILM COATED in 1 BOTTLE (71335-0548-8) 2019-01-230000-00-00NoNoCurrent
71335-0548-97133505480945 TABLET, FILM COATED in 1 BOTTLE (71335-0548-9) 2024-04-030000-00-00NoNoCurrent