FDA.reportPublic FDA data

TOPIRAMATE

Product NDC
72603-124
11-digit product format
726030124
Labeler code
72603
Product ID
72603-124_a1168608-1b38-4cbe-92b2-dee1771593e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA210278
Marketing category
ANDA
Marketing start
2023-01-01
Substance
TOPIRAMATE
Active strength
200 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
TOPIRAMATE200 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
72603-124-01TOPIRAMATE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-124-01EA - Each72603-124dbc2e931-2233-4d5c-ab0f-7fe5d0a1c08e12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-124TOPIRAMATE CAPSULE, EXTENDED RELEASE [NORTHSTAR RXLLC]4Current NDC, Legacy NDC, 1 package rows20240928_b5f8da43-6daf-413c-9dcd-363617973738.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812427topiramate 100 MG Sprinkle 24HR Extended Release Oral CapsulePSNb5f8da43-6daf-413c-9dcd-3636179737385
1494769topiramate 150 MG Sprinkle 24HR Extended Release Oral CapsulePSNb5f8da43-6daf-413c-9dcd-3636179737385
1812419topiramate 200 MG Sprinkle 24HR Extended Release Oral CapsulePSNb5f8da43-6daf-413c-9dcd-3636179737385
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsulePSNb5f8da43-6daf-413c-9dcd-3636179737385
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsulePSNb5f8da43-6daf-413c-9dcd-3636179737385
1812427Sprinkle 24 HR topiramate 100 MG Extended Release Oral CapsuleSCDb5f8da43-6daf-413c-9dcd-3636179737385
1494769Sprinkle 24 HR topiramate 150 MG Extended Release Oral CapsuleSCDb5f8da43-6daf-413c-9dcd-3636179737385
1812419Sprinkle 24 HR topiramate 200 MG Extended Release Oral CapsuleSCDb5f8da43-6daf-413c-9dcd-3636179737385
1812421Sprinkle 24 HR topiramate 25 MG Extended Release Oral CapsuleSCDb5f8da43-6daf-413c-9dcd-3636179737385
1812425Sprinkle 24 HR topiramate 50 MG Extended Release Oral CapsuleSCDb5f8da43-6daf-413c-9dcd-3636179737385
1812427topiramate 100 MG Sprinkle 24 HR Extended Release Oral CapsuleSYb5f8da43-6daf-413c-9dcd-3636179737385
1494769topiramate 150 MG Sprinkle 24 HR Extended Release Oral CapsuleSYb5f8da43-6daf-413c-9dcd-3636179737385
1812419topiramate 200 MG Sprinkle 24 HR Extended Release Oral CapsuleSYb5f8da43-6daf-413c-9dcd-3636179737385
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsuleSYb5f8da43-6daf-413c-9dcd-3636179737385
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsuleSYb5f8da43-6daf-413c-9dcd-3636179737385

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72603-124-017260301240130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72603-124-01) 2023-01-010000-00-00NoNoCurrent