Home NDC 0093-7335 Topiramate
Product NDC 0093-7335
11-digit product format 000937335
Labeler code 0093
Product ID 0093-7335_da6731ca-e37e-4727-bc67-acd9d6625cbb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topiramate
Dosage form CAPSULE, COATED PELLETS
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076575
Marketing category ANDA
Marketing start 2009-04-17
Marketing end 0000-00-00
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 2023-12-31
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 1 · 4 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 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0093-7335-06 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0093-7335-06 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076575-001 TOPIRAMATE TOPIRAMATE 15MG CAPSULE / ORAL 2009-04-17 A076575-002 TOPIRAMATE TOPIRAMATE 25MG CAPSULE / ORAL 2009-04-17
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 3 · 88 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 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-04-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL 2009-04-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-04-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL 2009-04-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL 2009-04-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL 2009-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL 2009-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076575-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-04-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076575-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-04-17 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 78 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOPIRAMATE ACTIVE INGREDIENT 0H73WJJ391 TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 TOPIRAMATE ACTIVE MOIETY 0H73WJJ391 TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 AMMONIA INACTIVE INGREDIENT 5138Q19F1X TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 ETHYLCELLULOSE (7 MPA.S) INACTIVE INGREDIENT H3UP11403C TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 GELATIN INACTIVE INGREDIENT 2G86QN327L TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 SHELLAC INACTIVE INGREDIENT 46N107B71O TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 SUCROSE INACTIVE INGREDIENT C151H8M554 TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC] 14
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0093-7335-06 00093733506 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0093-7335-06) 2009-04-17 0000-00-00 No No Current