FDA.reportPublic FDA data

Topiramate

Product NDC
33261-400
11-digit product format
332610400
Labeler code
33261
Product ID
33261-400_bb2afcb1-4412-4841-a449-7feff8f10da0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA079162
Marketing category
ANDA
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
50 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
2018-12-31
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
33261-400-022020-01-31C16284748780-19d75b9d0-4a05-f424-e053-dadaa90a57ceTopiramate Tablets
33261-400-072020-01-31C16284748780-19d75b9d0-4a05-f424-e053-dadaa90a57ceTopiramate Tablets
33261-400-142020-01-31C16284748780-19d75b9d0-4a05-f424-e053-dadaa90a57ceTopiramate Tablets
33261-400-282020-01-31C16284748780-19d75b9d0-4a05-f424-e053-dadaa90a57ceTopiramate Tablets
33261-400-302020-01-31C16284748780-19d75b9d0-4a05-f424-e053-dadaa90a57ceTopiramate Tablets
33261-400-602020-01-31C16284748780-19d75b9d0-4a05-f424-e053-dadaa90a57ceTopiramate Tablets
33261-400-902020-01-31C16284748780-19d75b9d0-4a05-f424-e053-dadaa90a57ceTopiramate Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-400-02Topiramate120 in 1 BOTTLE, PLASTICTABLET1201
33261-400-07Topiramate7 in 1 BOTTLE, PLASTICTABLET71
33261-400-14Topiramate14 in 1 BOTTLE, PLASTICTABLET141
33261-400-28Topiramate28 in 1 BOTTLE, PLASTICTABLET281
33261-400-30Topiramate30 in 1 BOTTLE, PLASTICTABLET301
33261-400-60Topiramate60 in 1 BOTTLE, PLASTICTABLET601
33261-400-90Topiramate90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-400-02EA - Each33261-40098c4d30f-756d-4f33-a0ad-cf8884816bea12015-10-02
33261-400-07EA - Each33261-400a275f155-7cb9-4b20-b145-cf1d8fc250bf12015-10-02
33261-400-14EA - Each33261-4004c2c10ed-1445-4904-95f3-03444aa3bb2712015-10-02
33261-400-28EA - Each33261-400fc42041c-af7c-4d7d-b9f7-e674e97b585e12015-10-02
33261-400-30EA - Each33261-4006f48ce55-ec4a-41f7-a844-8c53798fd1ab12015-10-02
33261-400-60EA - Each33261-400b1cbf026-34fb-42b9-a689-dd636449e0be12015-10-02
33261-400-90EA - Each33261-400748d88a7-d712-49fc-835e-7813fd6aceef12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-400TOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 7 package rows20140213_eddc5abc-ed77-46ba-94a2-ad666cf28e23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSNeddc5abc-ed77-46ba-94a2-ad666cf28e231
151226topiramate 50 MG Oral TabletPSNeddc5abc-ed77-46ba-94a2-ad666cf28e231
199889topiramate 100 MG Oral TabletSCDeddc5abc-ed77-46ba-94a2-ad666cf28e231
151226topiramate 50 MG Oral TabletSCDeddc5abc-ed77-46ba-94a2-ad666cf28e231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-400-0233261040002120 in 1 BOTTLE, PLASTICHistorical
33261-400-07332610400077 in 1 BOTTLE, PLASTICHistorical
33261-400-143326104001414 in 1 BOTTLE, PLASTICHistorical
33261-400-283326104002828 in 1 BOTTLE, PLASTICHistorical
33261-400-303326104003030 in 1 BOTTLE, PLASTICHistorical
33261-400-603326104006060 in 1 BOTTLE, PLASTICHistorical
33261-400-903326104009090 in 1 BOTTLE, PLASTICHistorical