Home NDC 21695-130 Topamax
Product NDC 21695-130
11-digit product format 216950130
Labeler code 21695
Product ID 21695-130_202b1a2a-11dc-4c3d-aa53-27512a98a042
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name topiramate
Dosage form TABLET, COATED
Route ORAL
Labeler Rebel Distributors Corp
Application NDA020505
Marketing category NDA
Marketing start 1997-01-01
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 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 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 21695-130-15 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 21695-130-15 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 21695-130-15 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 21695-130-15 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 21695-130-15 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 21695-130-15 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 21695-130-15 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 21695-130-15 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 21695-130-15 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 21695-130-15 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 21695-130-15 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 21695-130-15 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 21695-130-15 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 21695-130-15 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 21695-130-15 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 21695-130-15 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 21695-130-15 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 21695-130-15 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 21695-130-15 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 21695-130-15 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 21695-130-15 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 21695-130-15 110d247fa046…a55b01930146…
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.
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 21695-130-15 Topamax 15 in 1 BOTTLE TABLET, COATED 15 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded topiramate ACTIVE INGREDIENT 0H73WJJ391 TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1 topiramate ACTIVE MOIETY 0H73WJJ391 TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1 sodium starch glycolate type A potato INACTIVE INGREDIENT 5856J3G2A2 TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1 water INACTIVE INGREDIENT 059QF0KO0R TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-130 TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 1 package rows 20110104_202b1a2a-11dc-4c3d-aa53-27512a98a042.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.
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 21695-130-15 21695013015 15 in 1 BOTTLE Historical