FDA.reportPublic FDA data

topiramate

Product NDC
65841-652
11-digit product format
658410652
Labeler code
65841
Product ID
65841-652_c45924d5-c45b-4f31-afa5-0cbc090d2816
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA078877
Marketing category
ANDA
Marketing start
2009-10-14
Substance
TOPIRAMATE
Active strength
25 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
TOPIRAMATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui205315, 205316, 252413

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
65841-652-01topiramate100 in 1 BOTTLECAPSULE, COATED PELLETS10011
65841-652-05topiramate500 in 1 BOTTLECAPSULE, COATED PELLETS50011
65841-652-10topiramate1000 in 1 BOTTLECAPSULE, COATED PELLETS100011
65841-652-14topiramate60 in 1 BOTTLECAPSULE, COATED PELLETS6011
65841-652-16topiramate90 in 1 BOTTLECAPSULE, COATED PELLETS9011
65841-652-17topiramate28 in 1 BOTTLECAPSULE, COATED PELLETS2811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-652TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS LIFESCIENCES LIMITED]11Current NDC, Legacy NDC, 6 package rows20241027_6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205316topiramate 15 MG Oral CapsulePSN6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b11
205315topiramate 25 MG Oral CapsulePSN6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b11
252413topiramate 50 MG Oral CapsulePSN6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b11
205316topiramate 15 MG Oral CapsuleSCD6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b11
205315topiramate 25 MG Oral CapsuleSCD6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b11
252413topiramate 50 MG Oral CapsuleSCD6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-652-0165841065201100 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-01) 2009-10-140000-00-00NoNoCurrent
65841-652-0565841065205500 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-05) 2009-10-140000-00-00NoNoCurrent
65841-652-10658410652101000 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-10) 2009-10-140000-00-00NoNoCurrent
65841-652-146584106521460 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-14) 2009-10-140000-00-00NoNoCurrent
65841-652-166584106521690 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-16) 2009-10-140000-00-00NoNoCurrent
65841-652-176584106521728 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-17) 2009-10-140000-00-00NoNoCurrent