Home NDC 67877-868 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A218482-001 TOPIRAMATE TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 A218482-002 TOPIRAMATE TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13
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 2026-09-14 22:38:34 2026-08 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218482-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2024-06-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218482-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2024-06-13 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Topiramate
Listing expiration 2026-12-31 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 67877-868-05 Topiramate 500 in 1 BOTTLE CAPSULE 500 6 67877-868-33 Topiramate 1 in 1 CARTON CAPSULE 1 6 67877-868-33 Topiramate 10 in 1 BLISTER PACK CAPSULE 10 6 67877-868-60 Topiramate 60 in 1 BOTTLE CAPSULE 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-868 TOPIRAMATE CAPSULE [ASCEND LABORATORIES, LLC] 4 Current NDC, 4 package rows 20240810_cb966bcb-3af7-4dbe-b540-58d473b891e5.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 Units Marketing start Sample Exclude flag Status 67877-868-05 67877086805 500 CAPSULE in 1 BOTTLE (67877-868-05) 500 capsule 2024-08-05 No No Current 67877-868-33 67877086833 1 BLISTER PACK in 1 CARTON (67877-868-33) / 10 CAPSULE in 1 BLISTER PACK 1 blister pack 2024-08-05 No No Current 67877-868-60 67877086860 60 CAPSULE in 1 BOTTLE (67877-868-60) 60 capsule 2024-08-05 No No Current