Home NDC 50458-645 Topamax
Product NDC 50458-645
11-digit product format 504580645
Labeler code 50458
Product ID 50458-645_1c7483cf-95db-4b1c-ae4c-b11bc95a6ad8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name topiramate
Dosage form CAPSULE, COATED PELLETS
Route ORAL
Labeler Janssen Pharmaceuticals, Inc.
Application NDA020844
Marketing category NDA
Marketing start 1998-11-01
Substance TOPIRAMATE
Active strength 25 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020844-001 TOPAMAX TOPIRAMATE 15MG CAPSULE / ORAL AB RLD 1998-10-26 N020844-002 TOPAMAX TOPIRAMATE 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 N020844-003 TOPAMAX SPRINKLE TOPIRAMATE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 4 · 123 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 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Additional Listing Data#
Finished product Yes
Brand name base Topamax
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOPIRAMATE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0H73WJJ391 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 151226 Internal RxNorm lookup 151227 Internal RxNorm lookup 151228 Internal RxNorm lookup 151229 Internal RxNorm lookup 152855 Internal RxNorm lookup 199888 Internal RxNorm lookup 199889 Internal RxNorm lookup 199890 Internal RxNorm lookup 205315 Internal RxNorm lookup 205316 Internal RxNorm lookup 845478 Internal RxNorm lookup 845479 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50458-645-65 Topamax 60 in 1 BOTTLE CAPSULE, COATED PELLETS 60 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded topiramate ACTIVE INGREDIENT 0H73WJJ391 TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 topiramate ACTIVE MOIETY 0H73WJJ391 TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 cellulose acetate INACTIVE INGREDIENT 3J2P07GVB6 TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 gelatin INACTIVE INGREDIENT 2G86QN327L TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 povidones INACTIVE INGREDIENT FZ989GH94E TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 raw sugar INACTIVE INGREDIENT 8M707QY5GH TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 sodium starch glycolate type A potato INACTIVE INGREDIENT 5856J3G2A2 TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 sorbitan monolaurate INACTIVE INGREDIENT 6W9PS8B71J TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14 water INACTIVE INGREDIENT 059QF0KO0R TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50458-645 TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] 28 Current NDC, Legacy NDC, 1 package rows 20250326_21628112-0c47-11df-95b3-498d55d89593.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50458-645-65 50458064565 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-645-65) 1998-11-01 0000-00-00 No No Current