FDA.reportPublic FDA data

Topiramate

Product NDC
43063-734
11-digit product format
430630734
Labeler code
43063
Product ID
43063-734_39f9738a-570e-d6a6-e063-6294a90ac1ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076343
Marketing category
ANDA
Marketing start
2014-06-12
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

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
43063-734-07Topiramate7 in 1 BOTTLE, PLASTICTABLET723
43063-734-21Topiramate21 in 1 BOTTLE, PLASTICTABLET2123
43063-734-30Topiramate30 in 1 BOTTLE, PLASTICTABLET3023
43063-734-60Topiramate60 in 1 BOTTLE, PLASTICTABLET6023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-734-07EA - Each43063-734ddeb7784-8be3-4127-9b50-a20e02108ca212018-04-19
43063-734-21EA - Each43063-73458615c26-5b3f-4bdb-8bd8-1304230f668c12017-03-06
43063-734-30EA - Each43063-7344bafdae6-1ce8-4df8-bfcb-7301b037f83f12017-03-06
43063-734-60EA - Each43063-73494a1baa4-c137-437c-9eaa-c5c17e5b37b212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-734TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 4 package rows20250316_e39d2549-b489-426d-b576-741537e112e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSNe39d2549-b489-426d-b576-741537e112e723
151226topiramate 50 MG Oral TabletSCDe39d2549-b489-426d-b576-741537e112e723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-734-07430630734077 TABLET in 1 BOTTLE, PLASTIC (43063-734-07) 7 tablet2017-03-070000-00-00NoNoCurrent
43063-734-214306307342121 TABLET in 1 BOTTLE, PLASTIC (43063-734-21) 21 tablet2017-01-310000-00-00NoNoCurrent
43063-734-304306307343030 TABLET in 1 BOTTLE, PLASTIC (43063-734-30) 30 tablet2017-01-040000-00-00NoNoCurrent
43063-734-604306307346060 TABLET in 1 BOTTLE, PLASTIC (43063-734-60) 60 tablet2016-12-280000-00-00NoNoCurrent