FDA.reportPublic FDA data

Topiramate

Product NDC
67877-868
11-digit product format
678770868
Labeler code
67877
Product ID
67877-868_8dde15e5-8f0f-43bd-847f-08f5c015e4a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA218482
Marketing category
ANDA
Marketing start
2024-08-05
Substance
TOPIRAMATE
Active strength
15 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
TOPIRAMATE15 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-868-05Topiramate500 in 1 BOTTLECAPSULE5006
67877-868-33Topiramate1 in 1 CARTONCAPSULE16
67877-868-33Topiramate10 in 1 BLISTER PACKCAPSULE106
67877-868-60Topiramate60 in 1 BOTTLECAPSULE606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-868-60EA - Each67877-86894512f8b-9819-4bb1-a306-477a05fe772e12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-868TOPIRAMATE CAPSULE [ASCEND LABORATORIES, LLC]4Current NDC, 4 package rows20240810_cb966bcb-3af7-4dbe-b540-58d473b891e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205316topiramate 15 MG Oral CapsulePSNcb966bcb-3af7-4dbe-b540-58d473b891e56
205315topiramate 25 MG Oral CapsulePSNcb966bcb-3af7-4dbe-b540-58d473b891e56
205316topiramate 15 MG Oral CapsuleSCDcb966bcb-3af7-4dbe-b540-58d473b891e56
205315topiramate 25 MG Oral CapsuleSCDcb966bcb-3af7-4dbe-b540-58d473b891e56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67877-868-0567877086805500 CAPSULE in 1 BOTTLE (67877-868-05) 500 capsule2024-08-05NoNoHistorical
67877-868-33678770868331 BLISTER PACK in 1 CARTON (67877-868-33) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2024-08-05NoNoHistorical
67877-868-606787708686060 CAPSULE in 1 BOTTLE (67877-868-60) 60 capsule2024-08-05NoNoHistorical