Home NDC 0615-8595 Topiramate
Product NDC 0615-8595
11-digit product format 006158595
Labeler code 0615
Product ID 0615-8595_ef25c664-5229-41f1-9125-b18232e135ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topiramate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application ANDA078462
Marketing category ANDA
Marketing start 2009-03-27
Substance TOPIRAMATE
Active strength 100 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078462-001 TOPIRAMATE TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 A078462-002 TOPIRAMATE TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 A078462-003 TOPIRAMATE TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 A078462-004 TOPIRAMATE TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A078462-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A078462-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A078462-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A078462-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 4 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Topiramate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOPIRAMATE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0H73WJJ391 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 151226 Internal RxNorm lookup 199888 Internal RxNorm lookup 199889 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0615-8595-39 Topiramate 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0615-8595-39 00615859539 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8595-39) 2025-10-21 No No Current