Home NDC 65862-171 Topiramate
Product NDC 65862-171
11-digit product format 658620171
Labeler code 65862
Product ID 65862-171_67afee59-3d84-418f-832c-d00abd43fe5b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topiramate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA078462
Marketing category ANDA
Marketing start 2009-03-27
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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 65862-171 UNFINISHED Active or certified unfinished drug listing 2026-08-03 unfinished package package 65862-171 65862-171-19 UNFINISHED Active or certified unfinished drug listing 2026-08-03
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 · 42 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 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 65862-171-19 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 65862-171-19 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 65862-171-19 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 65862-171-19 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 65862-171-19 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 65862-171-19 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 65862-171-19 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 65862-171-19 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 65862-171-19 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 65862-171-19 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 65862-171-19 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 65862-171-19 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 65862-171-19 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 65862-171-19 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 65862-171-19 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 65862-171-19 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 65862-171-19 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 65862-171-19 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 65862-171-19 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 unfinished product product 263afe128892…91768de4ddbe…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 65862-171-19 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 65862-171-19 5b2001dcd8f5…54b53d4dc9e4…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A078462-001 TOPIRAMATE TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 A078462-002 TOPIRAMATE TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 A078462-003 TOPIRAMATE TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 A078462-004 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 · 164 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 A078462-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078462-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078462-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078462-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078462-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078462-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078462-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078462-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078462-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078462-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078462-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078462-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078462-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078462-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078462-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078462-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078462-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078462-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078462-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078462-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078462-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078462-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078462-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078462-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078462-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078462-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078462-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078462-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078462-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078462-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078462-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078462-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078462-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078462-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078462-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078462-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078462-001 TOPIRAMATE 25MG TABLET / ORAL AB 2009-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078462-002 TOPIRAMATE 50MG TABLET / ORAL AB 2009-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078462-003 TOPIRAMATE 100MG TABLET / ORAL AB 2009-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078462-004 TOPIRAMATE 200MG TABLET / ORAL AB 2009-03-27 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Topiramate
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 · 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 65862-171-05 Topiramate 500 in 1 BOTTLE TABLET, FILM COATED 500 33 65862-171-60 Topiramate 60 in 1 BOTTLE TABLET, FILM COATED 60 33 65862-171-99 Topiramate 1000 in 1 BOTTLE TABLET, FILM COATED 1000 33
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOPIRAMATE ACTIVE INGREDIENT 0H73WJJ391 TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 TOPIRAMATE ACTIVE MOIETY 0H73WJJ391 TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-171 TOPIRAMATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 31 Current NDC, Legacy NDC, 3 package rows 20250508_32b48ea0-a215-43b8-83b4-a5435a686d68.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 Marketing start Marketing end Sample Exclude flag Status 65862-171-05 65862017105 500 TABLET, FILM COATED in 1 BOTTLE (65862-171-05) 2022-04-11 0000-00-00 No No Current 65862-171-19 65862017119 10000 TABLET, FILM COATED in 1 BAG (65862-171-19) 27-MAR-09 Current 65862-171-60 65862017160 60 TABLET, FILM COATED in 1 BOTTLE (65862-171-60) 2009-03-27 0000-00-00 No No Current 65862-171-99 65862017199 1000 TABLET, FILM COATED in 1 BOTTLE (65862-171-99) 2022-04-11 0000-00-00 No No Current