Home NDC 50458-647 Topamax
Product NDC 50458-647
11-digit product format 504580647
Labeler code 50458
Product ID 50458-647_d7103f8b-d7c0-4809-8902-85174c517c8e
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 15 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 44 .
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N020844-003 TOPAMAX SPRINKLE TOPIRAMATE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26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 · 132 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 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020844-003 TOPAMAX SPRINKLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1998-10-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020844-001 TOPAMAX 15MG CAPSULE / ORAL AB RLD 1998-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020844-002 TOPAMAX 25MG CAPSULE / ORAL AB RLD, RS 1998-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Observed Orange Book patent history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Topamax
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOPIRAMATE 15 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50458-647-65 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 50458-647 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
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 50458-647-65 50458064765 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-647-65) 1998-11-01 0000-00-00 No No Current