Home NDC 23155-894-06 TOPIRAMATE
Product NDC 23155-894
Requested package NDC 23155-894-06
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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078418-001 TOPIRAMATE TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 A078418-002 TOPIRAMATE TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 A078418-003 TOPIRAMATE TOPIRAMATE 50MG CAPSULE / ORAL AB 2026-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
Product history page 1 of 3 · 87 observed 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 2026-08-18 06:07:40 2026-07 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078418-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2026-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078418-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2026-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-10-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL 2009-10-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-10-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL 2009-10-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-10-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL 2009-10-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078418-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-10-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078418-002 TOPIRAMATE 25MG CAPSULE / ORAL 2009-10-14 74a2ff9319b5…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 23155-894-06 TOPIRAMATE 60 in 1 BOTTLE CAPSULE 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23155-894 TOPIRAMATE (TOPIRAMATE SPINKLE) CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] 2 Current NDC, 1 package rows 20250325_1730870d-e661-41f9-bd0d-d8daaf087819.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 Marketing end Sample Exclude flag Status 23155-894-06 23155089406 60 CAPSULE in 1 BOTTLE (23155-894-06) 60 capsule 2024-02-16 2026-08-31 No No Historical