Home NDC 55289-433 Topamax
Product NDC 55289-433
11-digit product format 552890433
Labeler code 55289
Product ID 55289-433_d9f5fa7c-4ccd-0be8-e053-2a95a90ab074
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name topiramate
Dosage form TABLET, COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA020505
Marketing category NDA
Marketing start 1997-01-01
Marketing end 0000-00-00
Substance TOPIRAMATE
Active strength 50 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 2023-12-31
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 55289-433-30 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 55289-433-30 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 55289-433-30 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 55289-433-30 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 55289-433-30 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 55289-433-30 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 55289-433-30 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 55289-433-30 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 55289-433-30 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 55289-433-30 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 55289-433-30 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 55289-433-30 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 264 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 2026-10-15 13:18:30 2026-09 N020505-001 TOPAMAX 100MG TABLET / ORAL AB RLD, RS 1996-12-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020505-002 TOPAMAX 200MG TABLET / ORAL AB RLD 1996-12-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020505-003 TOPAMAX 300MG TABLET / ORAL 1996-12-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020505-004 TOPAMAX 25MG TABLET / ORAL AB RLD 1996-12-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020505-005 TOPAMAX 50MG TABLET / ORAL AB RLD 1996-12-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020505-006 TOPAMAX 400MG TABLET / ORAL 1996-12-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020505-001 TOPAMAX 100MG TABLET / ORAL AB RLD, RS 1996-12-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020505-002 TOPAMAX 200MG TABLET / ORAL AB RLD 1996-12-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020505-003 TOPAMAX 300MG TABLET / ORAL 1996-12-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020505-004 TOPAMAX 25MG TABLET / ORAL AB RLD 1996-12-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020505-005 TOPAMAX 50MG TABLET / ORAL AB RLD 1996-12-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020505-006 TOPAMAX 400MG TABLET / ORAL 1996-12-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020505-001 TOPAMAX 100MG TABLET / ORAL AB RLD, RS 1996-12-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020505-002 TOPAMAX 200MG TABLET / ORAL AB RLD 1996-12-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020505-003 TOPAMAX 300MG TABLET / ORAL 1996-12-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020505-004 TOPAMAX 25MG TABLET / ORAL AB RLD 1996-12-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020505-005 TOPAMAX 50MG TABLET / ORAL AB RLD 1996-12-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020505-006 TOPAMAX 400MG TABLET / ORAL 1996-12-24 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 5 · 176 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded topiramate ACTIVE INGREDIENT 0H73WJJ391 TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] 7 topiramate ACTIVE MOIETY 0H73WJJ391 TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] 7 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] 7 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] 7 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] 7 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] 7 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] 7 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] 7 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] 7 sodium starch glycolate type A potato INACTIVE INGREDIENT 5856J3G2A2 TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] 7 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] 7 water INACTIVE INGREDIENT 059QF0KO0R TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] 7
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-433-30 55289043330 30 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-433-30) 2012-01-18 0000-00-00 No No Current