FDA.reportPublic FDA data

Topiramate

Product NDC
71335-0325
11-digit product format
713350325
Labeler code
71335
Product ID
71335-0325_e3045e19-5284-4f12-9fc8-046a1baf004b
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
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
71335-0325-1Topiramate60 in 1 BOTTLETABLET, FILM COATED6018
71335-0325-2Topiramate30 in 1 BOTTLETABLET, FILM COATED3018
71335-0325-3Topiramate90 in 1 BOTTLETABLET, FILM COATED9018
71335-0325-4Topiramate120 in 1 BOTTLETABLET, FILM COATED12018
71335-0325-5Topiramate50 in 1 BOTTLETABLET, FILM COATED5018
71335-0325-6Topiramate14 in 1 BOTTLETABLET, FILM COATED1418
71335-0325-7Topiramate45 in 1 BOTTLETABLET, FILM COATED4518
71335-0325-8Topiramate7 in 1 BOTTLETABLET, FILM COATED718

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0325-1EA - Each71335-03255fe77aac-9f85-4db9-88aa-bd0c1037fd1412019-03-12
71335-0325-2EA - Each71335-0325df299d0d-e66b-4d3b-9545-ce9a42022b4f12019-11-12
71335-0325-3EA - Each71335-0325a2e2d0ca-029a-4561-aa85-65fe9e31016c12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0325TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]18Current NDC, Legacy NDC, 8 package rows20240830_484c132f-3d3d-4218-b22f-82e9b56cc2f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN484c132f-3d3d-4218-b22f-82e9b56cc2f418
199889topiramate 100 MG Oral TabletSCD484c132f-3d3d-4218-b22f-82e9b56cc2f418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0325-17133503250160 TABLET, FILM COATED in 1 BOTTLE (71335-0325-1) 2018-11-270000-00-00NoNoCurrent
71335-0325-27133503250230 TABLET, FILM COATED in 1 BOTTLE (71335-0325-2) 2018-12-280000-00-00NoNoCurrent
71335-0325-37133503250390 TABLET, FILM COATED in 1 BOTTLE (71335-0325-3) 2018-11-260000-00-00NoNoCurrent
71335-0325-471335032504120 TABLET, FILM COATED in 1 BOTTLE (71335-0325-4) 2022-03-090000-00-00NoNoCurrent
71335-0325-57133503250550 TABLET, FILM COATED in 1 BOTTLE (71335-0325-5) 2022-03-090000-00-00NoNoCurrent
71335-0325-67133503250614 TABLET, FILM COATED in 1 BOTTLE (71335-0325-6) 2019-05-230000-00-00NoNoCurrent
71335-0325-77133503250745 TABLET, FILM COATED in 1 BOTTLE (71335-0325-7) 2022-03-090000-00-00NoNoCurrent
71335-0325-8713350325087 TABLET, FILM COATED in 1 BOTTLE (71335-0325-8) 2019-05-230000-00-00NoNoCurrent