FDA.reportPublic FDA data

Topiramate

Product NDC
69680-178
11-digit product format
696800178
Labeler code
69680
Product ID
69680-178_0a7f1a1b-961e-4458-8312-7920a78e4dbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Vitruvias Therapeutics, Inc.
Application
ANDA215638
Marketing category
ANDA
Marketing start
2025-04-07
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
2027-12-31
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
TOPIRAMATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui1494769, 1812419, 1812421, 1812425, 1812427

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
69680-178-30Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69680-178TOPIRAMATE CAPSULE, EXTENDED RELEASE [VITRUVIAS THERAPEUTICS, INC.]1Current NDC, 1 package rows20250408_a9d7c5ef-daf9-4f97-8673-7f4a2007f408.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812427topiramate 100 MG Sprinkle 24HR Extended Release Oral CapsulePSNa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1494769topiramate 150 MG Sprinkle 24HR Extended Release Oral CapsulePSNa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1812419topiramate 200 MG Sprinkle 24HR Extended Release Oral CapsulePSNa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsulePSNa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsulePSNa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1812427Sprinkle 24 HR topiramate 100 MG Extended Release Oral CapsuleSCDa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1494769Sprinkle 24 HR topiramate 150 MG Extended Release Oral CapsuleSCDa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1812419Sprinkle 24 HR topiramate 200 MG Extended Release Oral CapsuleSCDa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1812421Sprinkle 24 HR topiramate 25 MG Extended Release Oral CapsuleSCDa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1812425Sprinkle 24 HR topiramate 50 MG Extended Release Oral CapsuleSCDa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1812427topiramate 100 MG Sprinkle 24 HR Extended Release Oral CapsuleSYa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1494769topiramate 150 MG Sprinkle 24 HR Extended Release Oral CapsuleSYa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1812419topiramate 200 MG Sprinkle 24 HR Extended Release Oral CapsuleSYa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsuleSYa9d7c5ef-daf9-4f97-8673-7f4a2007f4082
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsuleSYa9d7c5ef-daf9-4f97-8673-7f4a2007f4082

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69680-178-306968001783030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-178-30) 2025-04-07NoNoCurrent