FDA.reportPublic FDA data

Topiramate

Product NDC
71610-492
11-digit product format
716100492
Labeler code
71610
Product ID
71610-492_875c3303-147e-4bdf-98f2-8355c056e18f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA079162
Marketing category
ANDA
Marketing start
2020-09-07
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
Rxcui151226, 199888, 199889, 199890

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
71610-492-30Topiramate30 in 1 BOTTLETABLET302
71610-492-45Topiramate45 in 1 BOTTLETABLET452
71610-492-53Topiramate60 in 1 BOTTLETABLET602
71610-492-60Topiramate90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-492-30EA - Each71610-49281aa8a5b-ff1a-4a90-8ece-6b78d603f22712021-02-05
71610-492-45EA - Each71610-4927a944300-3050-4667-a70c-3d46423d1c3712021-02-05
71610-492-53EA - Each71610-49224d1556c-63b2-4dbc-9b73-d71ef9eedfaa12021-02-05
71610-492-60EA - Each71610-4920bd7bbc1-0b90-4ed1-9c05-56500c7f048412021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-492TOPIRAMATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 4 package rows20210504_3b18b43c-0de2-4acf-b0d5-f1b601d496de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN3b18b43c-0de2-4acf-b0d5-f1b601d496de2
199890topiramate 200 MG Oral TabletPSN3b18b43c-0de2-4acf-b0d5-f1b601d496de2
199888topiramate 25 MG Oral TabletPSN3b18b43c-0de2-4acf-b0d5-f1b601d496de2
151226topiramate 50 MG Oral TabletPSN3b18b43c-0de2-4acf-b0d5-f1b601d496de2
199889topiramate 100 MG Oral TabletSCD3b18b43c-0de2-4acf-b0d5-f1b601d496de2
199890topiramate 200 MG Oral TabletSCD3b18b43c-0de2-4acf-b0d5-f1b601d496de2
199888topiramate 25 MG Oral TabletSCD3b18b43c-0de2-4acf-b0d5-f1b601d496de2
151226topiramate 50 MG Oral TabletSCD3b18b43c-0de2-4acf-b0d5-f1b601d496de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-492-307161004923030 TABLET in 1 BOTTLE (71610-492-30) 30 tablet2020-11-170000-00-00NoNoCurrent
71610-492-457161004924545 TABLET in 1 BOTTLE (71610-492-45) 45 tablet2020-11-170000-00-00NoNoCurrent
71610-492-537161004925360 TABLET in 1 BOTTLE (71610-492-53) 60 tablet2020-11-170000-00-00NoNoCurrent
71610-492-607161004926090 TABLET in 1 BOTTLE (71610-492-60) 90 tablet2020-11-170000-00-00NoNoCurrent