Home NDC 71610-486 Topiramate
Product NDC 71610-486
11-digit product format 716100486
Labeler code 71610
Product ID 71610-486_875c3303-147e-4bdf-98f2-8355c056e18f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topiramate
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA079162
Marketing category ANDA
Marketing start 2020-09-07
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079162-001 TOPIRAMATE TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 A079162-002 TOPIRAMATE TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 A079162-003 TOPIRAMATE TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 A079162-004 TOPIRAMATE TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27
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 5 · 172 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 2026-09-14 22:38:34 2026-08 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079162-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079162-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079162-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079162-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
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 Topiramate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOPIRAMATE 50 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 151226 Internal RxNorm lookup 199888 Internal RxNorm lookup 199889 Internal RxNorm lookup 199890 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 71610-486-30 Topiramate 30 in 1 BOTTLE TABLET 30 2 71610-486-53 Topiramate 60 in 1 BOTTLE TABLET 60 2 71610-486-60 Topiramate 90 in 1 BOTTLE TABLET 90 2 71610-486-80 Topiramate 180 in 1 BOTTLE TABLET 180 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-486 TOPIRAMATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Current NDC, Legacy NDC, 4 package rows 20210504_3b18b43c-0de2-4acf-b0d5-f1b601d496de.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71610-486-30 71610048630 30 TABLET in 1 BOTTLE (71610-486-30) 30 tablet 2020-12-11 0000-00-00 No No Current 71610-486-53 71610048653 60 TABLET in 1 BOTTLE (71610-486-53) 60 tablet 2021-04-07 0000-00-00 No No Current 71610-486-60 71610048660 90 TABLET in 1 BOTTLE (71610-486-60) 90 tablet 2020-11-10 0000-00-00 No No Current 71610-486-80 71610048680 180 TABLET in 1 BOTTLE (71610-486-80) 180 tablet 2020-11-16 0000-00-00 No No Current