Home NDC 70518-1393 Topamax
Product NDC 70518-1393
11-digit product format 705181393
Labeler code 70518
Product ID 70518-1393_92ba5957-e541-1a75-e053-2a95a90ad475
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name topiramate
Dosage form TABLET, COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA020505
Marketing category NDA
Marketing start 2018-08-29
Marketing end 0000-00-00
Substance TOPIRAMATE
Active strength 100 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 No
Listing certified through 2020-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-1393-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-1393-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70518-1393-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70518-1393-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70518-1393-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70518-1393-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-1393-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-1393-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-1393-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-1393-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-1393-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-1393-0 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020505-001 TOPAMAX TOPIRAMATE 100MG TABLET / ORAL AB RLD, RS 1996-12-24 N020505-002 TOPAMAX TOPIRAMATE 200MG TABLET / ORAL AB RLD 1996-12-24 N020505-003 TOPAMAX TOPIRAMATE 300MG TABLET / ORAL 1996-12-24 N020505-004 TOPAMAX TOPIRAMATE 25MG TABLET / ORAL AB RLD 1996-12-24 N020505-005 TOPAMAX TOPIRAMATE 50MG TABLET / ORAL AB RLD 1996-12-24 N020505-006 TOPAMAX TOPIRAMATE 400MG TABLET / ORAL 1996-12-24
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 7 · 246 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 2026-02-19 14:30 UTC 2026-02 N020505-001 TOPAMAX 100MG TABLET / ORAL AB RLD, RS 1996-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020505-002 TOPAMAX 200MG TABLET / ORAL AB RLD 1996-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020505-003 TOPAMAX 300MG TABLET / ORAL 1996-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020505-004 TOPAMAX 25MG TABLET / ORAL AB RLD 1996-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020505-005 TOPAMAX 50MG TABLET / ORAL AB RLD 1996-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020505-006 TOPAMAX 400MG TABLET / ORAL 1996-12-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020505-001 TOPAMAX 100MG TABLET / ORAL AB RLD, RS 1996-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020505-002 TOPAMAX 200MG TABLET / ORAL AB RLD 1996-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020505-003 TOPAMAX 300MG TABLET / ORAL 1996-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020505-004 TOPAMAX 25MG TABLET / ORAL AB RLD 1996-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020505-005 TOPAMAX 50MG TABLET / ORAL AB RLD 1996-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020505-006 TOPAMAX 400MG TABLET / ORAL 1996-12-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020505-001 TOPAMAX 100MG TABLET / ORAL AB RLD, RS 1996-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020505-002 TOPAMAX 200MG TABLET / ORAL AB RLD 1996-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020505-003 TOPAMAX 300MG TABLET / ORAL 1996-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020505-004 TOPAMAX 25MG TABLET / ORAL AB RLD 1996-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020505-005 TOPAMAX 50MG TABLET / ORAL AB RLD 1996-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020505-006 TOPAMAX 400MG TABLET / ORAL 1996-12-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020505-001 TOPAMAX 100MG TABLET / ORAL AB RLD, RS 1996-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020505-002 TOPAMAX 200MG TABLET / ORAL AB RLD 1996-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020505-003 TOPAMAX 300MG TABLET / ORAL 1996-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020505-004 TOPAMAX 25MG TABLET / ORAL AB RLD 1996-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020505-005 TOPAMAX 50MG TABLET / ORAL AB RLD 1996-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020505-006 TOPAMAX 400MG TABLET / ORAL 1996-12-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020505-001 TOPAMAX 100MG TABLET / ORAL AB RLD, RS 1996-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020505-002 TOPAMAX 200MG TABLET / ORAL AB RLD 1996-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020505-003 TOPAMAX 300MG TABLET / ORAL 1996-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020505-004 TOPAMAX 25MG TABLET / ORAL AB RLD 1996-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020505-005 TOPAMAX 50MG TABLET / ORAL AB RLD 1996-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020505-006 TOPAMAX 400MG TABLET / ORAL 1996-12-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020505-001 TOPAMAX 100MG TABLET / ORAL AB RLD, RS 1996-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020505-002 TOPAMAX 200MG TABLET / ORAL AB RLD 1996-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020505-003 TOPAMAX 300MG TABLET / ORAL 1996-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020505-004 TOPAMAX 25MG TABLET / ORAL AB RLD 1996-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020505-005 TOPAMAX 50MG TABLET / ORAL AB RLD 1996-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020505-006 TOPAMAX 400MG TABLET / ORAL 1996-12-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020505-001 TOPAMAX 100MG TABLET / ORAL AB RLD, RS 1996-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020505-002 TOPAMAX 200MG TABLET / ORAL AB RLD 1996-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020505-003 TOPAMAX 300MG TABLET / ORAL 1996-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020505-004 TOPAMAX 25MG TABLET / ORAL AB RLD 1996-12-24 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Topamax TOPIRAMATE Janssen Pharmaceuticals, Inc. 21628112-0c47-11df-95b3-498d55d89593 2026-03-12 Warnings, Adverse reactions Exact identifier application applno (NDA): 020505 application number: NDA020505