Home NDC 10544-628 Topiramate
Product NDC 10544-628
11-digit product format 105440628
Labeler code 10544
Product ID 10544-628_98f178c8-7659-4b64-afcd-755a7387addd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name topiramate
Dosage form TABLET
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA079162
Marketing category ANDA
Marketing start 2014-01-22
Marketing end 0000-00-00
Substance TOPIRAMATE
Active strength 25 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 10544-628-90 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 10544-628-90 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 10544-628-90 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 10544-628-90 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 10544-628-90 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 10544-628-90 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 10544-628-90 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10544-628-90 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10544-628-90 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10544-628-90 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10544-628-90 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 10544-628-90 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 10544-628-90 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 10544-628-90 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 10544-628-90 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 10544-628-90 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 10544-628-90 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 10544-628-90 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 10544-628-90 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 10544-628-90 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 10544-628-90 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 10544-628-90 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A079162-001 TOPIRAMATE TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 A079162-002 TOPIRAMATE TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 A079162-003 TOPIRAMATE TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 A079162-004 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.
Product history page 1 of 5 · 172 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 2026-09-14 22:38:34 2026-08 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10544-628-90 Topiramate 90 in 1 BOTTLE TABLET 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOPIRAMATE ACTIVE INGREDIENT 0H73WJJ391 TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] 1 TOPIRAMATE ACTIVE MOIETY 0H73WJJ391 TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] 1 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] 1 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] 1 Polyethylene Glycol 400 INACTIVE INGREDIENT B697894SGQ TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] 1 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] 1 Sodium Starch Glycolate Type A Potato INACTIVE INGREDIENT 5856J3G2A2 TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-628 TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 1 package rows 20150217_98f178c8-7659-4b64-afcd-755a7387addd.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-628-90 10544062890 90 in 1 BOTTLE Historical