FDA.reportPublic FDA data

TOPIRAMATE

Product NDC
23155-894
11-digit product format
231550894
Labeler code
23155
Product ID
23155-894_c6498e0a-7dbe-4132-897b-a2721fb2190c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate spinkle
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA078418
Marketing category
ANDA
Marketing start
2024-02-16
Marketing end
2026-08-31
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
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078418-001TOPIRAMATETOPIRAMATE15MGCAPSULE / ORALAB2009-10-14
A078418-002TOPIRAMATETOPIRAMATE25MGCAPSULE / ORALAB2009-10-14
A078418-003TOPIRAMATETOPIRAMATE50MGCAPSULE / ORALAB2026-02-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078418-001AB
A078418-002AB
A078418-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078418-001TOPIRAMATE15MGCAPSULE / ORALAB2009-10-14a50c72e98297…
2026-08-01 22:54:322026-06A078418-002TOPIRAMATE25MGCAPSULE / ORALAB2009-10-14a50c72e98297…
2026-08-01 22:54:322026-06A078418-003TOPIRAMATE50MGCAPSULE / ORALAB2026-02-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078418-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078418-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078418-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOPIRAMATETOPIRAMATE SPINKLEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1730870d-e661-41f9-bd0d-d8daaf0878192025-12-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078418
application number: ANDA078418
ndc (product): 23155-894

Additional Listing Data#

Finished product
Yes
Brand name base
TOPIRAMATE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0H73WJJ391Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205315Internal RxNorm lookup
205316Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1730870d-e661-41f9-bd0d-d8daaf087819Available on FDA.report

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-894-06TOPIRAMATE60 in 1 BOTTLECAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-894-06EA - Each23155-89499964620-de00-4ff1-9a1f-1599c4f60c2d12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-894TOPIRAMATE (TOPIRAMATE SPINKLE) CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]2Current NDC, 1 package rows20250325_1730870d-e661-41f9-bd0d-d8daaf087819.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205316topiramate 15 MG Oral CapsulePSN1730870d-e661-41f9-bd0d-d8daaf0878194
205315topiramate 25 MG Oral CapsulePSN1730870d-e661-41f9-bd0d-d8daaf0878194
205316topiramate 15 MG Oral CapsuleSCD1730870d-e661-41f9-bd0d-d8daaf0878194
205315topiramate 25 MG Oral CapsuleSCD1730870d-e661-41f9-bd0d-d8daaf0878194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-894-062315508940660 CAPSULE in 1 BOTTLE (23155-894-06) 60 capsule2024-02-162026-08-31NoNoHistorical