Home NDC 24979-210 Topiramate
Product NDC 24979-210
11-digit product format 249790210
Labeler code 24979
Product ID 24979-210_bf831629-b5b8-41c4-9e1c-a5e6e5532144
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topiramate
Dosage form CAPSULE
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA217694
Marketing category ANDA
Marketing start 2023-12-05
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217694-001 TOPIRAMATE TOPIRAMATE 15MG CAPSULE / ORAL AB 2023-12-05 A217694-002 TOPIRAMATE TOPIRAMATE 25MG CAPSULE / ORAL AB 2023-12-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 A217694-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2023-12-05 a50c72e98297…2026-08-01 22:54:32 2026-06 A217694-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2023-12-05 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A217694-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A217694-002 AB 1 a50c72e98297…
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 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Topiramate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOPIRAMATE 15 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205315 Internal RxNorm lookup 205316 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 24979-210-04 Topiramate 60 in 1 PACKAGE CAPSULE 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24979-210 TOPIRAMATE CAPSULE [UPSHER-SMITH LABORATORIES, LLC] 5 Current NDC, 1 package rows 20250410_e0d88f34-865c-441b-80e2-e814c9a7d670.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 24979-210-04 24979021004 60 CAPSULE in 1 PACKAGE (24979-210-04) 60 capsule 2023-12-05 No No Current