FDA.reportPublic FDA data

Topiramate

Product NDC
61919-213
11-digit product format
619190213
Labeler code
61919
Product ID
61919-213_4c490e55-407d-a23d-e063-6394a90ac099
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
C
Application
ANDA076343
Marketing category
ANDA
Marketing start
2024-04-17
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topiramate
Listing expiration
2027-12-31

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
61919-213-30Topiramate30 in 1 BOTTLETABLET304
61919-213-60Topiramate60 in 1 BOTTLETABLET604
61919-213-72Topiramate120 in 1 BOTTLETABLET1204
61919-213-90Topiramate90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-213-30EA - Each61919-2130cca17ee-91ca-4804-a2be-252ec7cd6e1f12024-05-16
61919-213-60EA - Each61919-213a09126da-2a27-491a-9aaf-95c66ea504de12026-03-17
61919-213-72EA - Each61919-21379061b66-ceb7-4e08-b5cc-391bd537759212026-03-17
61919-213-90EA - Each61919-21392cbf052-01bb-48b2-93b1-3b5d0f41315e12026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-213TOPIRAMATE TABLET [C]1Current NDC, 4 package rows20240418_164cb1f7-1a41-675f-e063-6294a90ae0dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN164cb1f7-1a41-675f-e063-6294a90ae0dd4
199889topiramate 100 MG Oral TabletSCD164cb1f7-1a41-675f-e063-6294a90ae0dd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61919-213-306191902133030 TABLET in 1 BOTTLE (61919-213-30) 30 tablet2024-04-17NoNoHistorical
61919-213-606191902136060 TABLET in 1 BOTTLE (61919-213-60) 60 tablet2024-04-17NoNoHistorical
61919-213-7261919021372120 TABLET in 1 BOTTLE (61919-213-72) 120 tablet2024-04-17NoNoHistorical
61919-213-906191902139090 TABLET in 1 BOTTLE (61919-213-90) 90 tablet2024-04-17NoNoHistorical