FDA.reportPublic FDA data

Topamax

Product NDC
21695-128
11-digit product format
216950128
Labeler code
21695
Product ID
21695-128_202b1a2a-11dc-4c3d-aa53-27512a98a042
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020505
Marketing category
NDA
Marketing start
1997-01-01
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
25 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-128-152019-09-24C16284748780-1934fe258-4cd7-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use TOPAMAX ® safely and effectively. See full prescribing information for TOPAMAX ® TOPAMAX ® (topiramate) TABLETS Initial U.S. Approval: 1996
21695-128-602019-09-24C16284748780-1934fe258-4cd7-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use TOPAMAX ® safely and effectively. See full prescribing information for TOPAMAX ® TOPAMAX ® (topiramate) TABLETS Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-128-15Topamax15 in 1 BOTTLETABLET, COATED151
21695-128-60Topamax60 in 1 BOTTLETABLET, COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-128-15EA - Each21695-128bdedad0e-2f42-4e42-8098-1dc4d712158b12012-07-24
21695-128-60EA - Each21695-128042df251-af0e-40ee-a393-6f9e2c72571512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
topiramateACTIVE INGREDIENT0H73WJJ391TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
topiramateACTIVE MOIETY0H73WJJ391TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ATOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-128TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110104_202b1a2a-11dc-4c3d-aa53-27512a98a042.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151228Topamax 100 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
152855Topamax 25 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
151227Topamax 50 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
199889topiramate 100 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
199888topiramate 25 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
151226topiramate 50 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
151228topiramate 100 MG Oral Tablet [Topamax]SBD202b1a2a-11dc-4c3d-aa53-27512a98a0421
152855topiramate 25 MG Oral Tablet [Topamax]SBD202b1a2a-11dc-4c3d-aa53-27512a98a0421
151227topiramate 50 MG Oral Tablet [Topamax]SBD202b1a2a-11dc-4c3d-aa53-27512a98a0421
199889topiramate 100 MG Oral TabletSCD202b1a2a-11dc-4c3d-aa53-27512a98a0421
199888topiramate 25 MG Oral TabletSCD202b1a2a-11dc-4c3d-aa53-27512a98a0421
151226topiramate 50 MG Oral TabletSCD202b1a2a-11dc-4c3d-aa53-27512a98a0421
151228Topamax 100 MG Oral TabletSY202b1a2a-11dc-4c3d-aa53-27512a98a0421
152855Topamax 25 MG Oral TabletSY202b1a2a-11dc-4c3d-aa53-27512a98a0421
151227Topamax 50 MG Oral TabletSY202b1a2a-11dc-4c3d-aa53-27512a98a0421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-128-152169501281515 in 1 BOTTLEHistorical
21695-128-602169501286060 in 1 BOTTLEHistorical