FDA.reportPublic FDA data

Topiramate

Product NDC
71335-0487
11-digit product format
713350487
Labeler code
71335
Product ID
71335-0487_ebf813da-167b-44ed-921d-015fdc8b6d61
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
50 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
TOPIRAMATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui151226

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
71335-0487-0Topiramate20 in 1 BOTTLETABLET, FILM COATED20105
71335-0487-1Topiramate30 in 1 BOTTLETABLET, FILM COATED30105
71335-0487-2Topiramate60 in 1 BOTTLETABLET, FILM COATED60105
71335-0487-3Topiramate90 in 1 BOTTLETABLET, FILM COATED90105
71335-0487-4Topiramate120 in 1 BOTTLETABLET, FILM COATED120105
71335-0487-5Topiramate7 in 1 BOTTLETABLET, FILM COATED7105
71335-0487-6Topiramate80 in 1 BOTTLETABLET, FILM COATED80105
71335-0487-7Topiramate14 in 1 BOTTLETABLET, FILM COATED14105
71335-0487-8Topiramate45 in 1 BOTTLETABLET, FILM COATED45105
71335-0487-9Topiramate28 in 1 BOTTLETABLET, FILM COATED28105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0487-1EA - Each71335-0487c76084c5-4690-4cf2-b7f3-eb914fd325de12019-02-13
71335-0487-2EA - Each71335-0487309f9929-7b2e-46f2-b77f-6adaf46022fd12019-02-13
71335-0487-4EA - Each71335-0487d7c81cbb-9d2d-46a1-8f24-45a2737e306412023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0487TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 10 package rows20240822_ffaacad8-4594-45a8-b292-02a84cd0c35b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSNffaacad8-4594-45a8-b292-02a84cd0c35b105
151226topiramate 50 MG Oral TabletSCDffaacad8-4594-45a8-b292-02a84cd0c35b105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0487-07133504870020 TABLET, FILM COATED in 1 BOTTLE (71335-0487-0) 2024-04-030000-00-00NoNoCurrent
71335-0487-17133504870130 TABLET, FILM COATED in 1 BOTTLE (71335-0487-1) 2018-12-040000-00-00NoNoCurrent
71335-0487-27133504870260 TABLET, FILM COATED in 1 BOTTLE (71335-0487-2) 2018-12-100000-00-00NoNoCurrent
71335-0487-37133504870390 TABLET, FILM COATED in 1 BOTTLE (71335-0487-3) 2021-04-090000-00-00NoNoCurrent
71335-0487-471335048704120 TABLET, FILM COATED in 1 BOTTLE (71335-0487-4) 2021-05-050000-00-00NoNoCurrent
71335-0487-5713350487057 TABLET, FILM COATED in 1 BOTTLE (71335-0487-5) 2024-04-030000-00-00NoNoCurrent
71335-0487-67133504870680 TABLET, FILM COATED in 1 BOTTLE (71335-0487-6) 2024-04-030000-00-00NoNoCurrent
71335-0487-77133504870714 TABLET, FILM COATED in 1 BOTTLE (71335-0487-7) 2022-10-100000-00-00NoNoCurrent
71335-0487-87133504870845 TABLET, FILM COATED in 1 BOTTLE (71335-0487-8) 2024-04-030000-00-00NoNoCurrent
71335-0487-97133504870928 TABLET, FILM COATED in 1 BOTTLE (71335-0487-9) 2021-09-150000-00-00NoNoCurrent