FDA.reportPublic FDA data

Topiramate

Product NDC
71610-486
11-digit product format
716100486
Labeler code
71610
Product ID
71610-486_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
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, 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
71610-486-30Topiramate30 in 1 BOTTLETABLET302
71610-486-53Topiramate60 in 1 BOTTLETABLET602
71610-486-60Topiramate90 in 1 BOTTLETABLET902
71610-486-80Topiramate180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-486-30EA - Each71610-486f3bbea02-1df6-4694-bd3c-4c1a1577402712021-02-05
71610-486-53EA - Each71610-4865ebd1829-a41a-43af-9344-30ea9fed9d6412021-07-15
71610-486-60EA - Each71610-48697c345e2-eebc-4be0-9592-aebc3d4fbbd012021-02-05
71610-486-80EA - Each71610-486cf317309-f145-40ba-9417-be6ef109e27012021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-486TOPIRAMATE 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
71610-486-307161004863030 TABLET in 1 BOTTLE (71610-486-30) 30 tablet2020-12-110000-00-00NoNoCurrent
71610-486-537161004865360 TABLET in 1 BOTTLE (71610-486-53) 60 tablet2021-04-070000-00-00NoNoCurrent
71610-486-607161004866090 TABLET in 1 BOTTLE (71610-486-60) 90 tablet2020-11-100000-00-00NoNoCurrent
71610-486-8071610048680180 TABLET in 1 BOTTLE (71610-486-80) 180 tablet2020-11-160000-00-00NoNoCurrent