FDA.reportPublic FDA data

Topiramate

Product NDC
24979-211
11-digit product format
249790211
Labeler code
24979
Product ID
24979-211_bf831629-b5b8-41c4-9e1c-a5e6e5532144
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA217694
Marketing category
ANDA
Marketing start
2023-12-05
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui205315, 205316

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24979-211-04Topiramate60 in 1 PACKAGECAPSULE606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-211-04EA - Each24979-2112ce73ad7-d138-4c37-8ed2-dd334debd50312024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-211TOPIRAMATE CAPSULE [UPSHER-SMITH LABORATORIES, LLC]5Current NDC, 1 package rows20250410_e0d88f34-865c-441b-80e2-e814c9a7d670.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205316topiramate 15 MG Oral CapsulePSNe0d88f34-865c-441b-80e2-e814c9a7d6706
205315topiramate 25 MG Oral CapsulePSNe0d88f34-865c-441b-80e2-e814c9a7d6706
205316topiramate 15 MG Oral CapsuleSCDe0d88f34-865c-441b-80e2-e814c9a7d6706
205315topiramate 25 MG Oral CapsuleSCDe0d88f34-865c-441b-80e2-e814c9a7d6706
205316topiramate 15 MG Oral CapsulePSN163e9f2d-27be-6d3f-e063-6394a90a58843
205315topiramate 25 MG Oral CapsulePSN163e9f2d-27be-6d3f-e063-6394a90a58843
205316topiramate 15 MG Oral CapsuleSCD163e9f2d-27be-6d3f-e063-6394a90a58843
205315topiramate 25 MG Oral CapsuleSCD163e9f2d-27be-6d3f-e063-6394a90a58843

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24979-211-042497902110460 CAPSULE in 1 PACKAGE (24979-211-04) 60 capsule2023-12-05NoNoCurrent