Home NDC 68462-218 Topiramate
Product NDC 68462-218
11-digit product format 684620218
Labeler code 68462
Product ID 68462-218_e4d3b13a-e354-421d-917a-613ad0a3ab35
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topiramate
Dosage form CAPSULE, COATED PELLETS
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA217869
Marketing category ANDA
Marketing start 2024-07-16
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 2027-12-31
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 A217869-001 TOPIRAMATE TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-07-16 A217869-002 TOPIRAMATE TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-07-16
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 2026-02-19 14:30 UTC 2026-02 A217869-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217869-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217869-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217869-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217869-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217869-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217869-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217869-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217869-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217869-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217869-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217869-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217869-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-07-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217869-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217869-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-07-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217869-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217869-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-07-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217869-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217869-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-07-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217869-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217869-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-07-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217869-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-07-16 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217869-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-07-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217869-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-07-16 a50c72e98297…
Observed Orange Book normalized TE history# 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 68462-218-60 Topiramate 60 in 1 BOTTLE CAPSULE, COATED PELLETS 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-218 TOPIRAMATE CAPSULE, COATED PELLETS [GLENMARK PHARMACEUTICALS INC., USA] 5 Current NDC, 1 package rows 20250524_872927eb-0b61-44bb-9892-3c700b6f2181.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68462-218-60 68462021860 60 CAPSULE, COATED PELLETS in 1 BOTTLE (68462-218-60) 2024-07-16 No No Current