Home NDC 21695-128 Topamax
Product NDC 21695-128
11-digit product format 216950128
Labeler code 21695
Product ID 21695-128_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 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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 5 of 5 · 176 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 21695-128-15 Topamax 15 in 1 BOTTLE TABLET, COATED 15 1 21695-128-60 Topamax 60 in 1 BOTTLE TABLET, COATED 60 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 21695-128 TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 2 package rows 20110104_202b1a2a-11dc-4c3d-aa53-27512a98a042.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 21695-128-15 21695012815 15 in 1 BOTTLE Historical 21695-128-60 21695012860 60 in 1 BOTTLE Historical