Home NDC 13668-032-05 TOPIRAMATE
Product NDC 13668-032
Requested package NDC 13668-032-05
11-digit product format 136680032
Labeler code 13668
Product ID 13668-032_16ea5453-3213-4fef-9918-92f5c7179798
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name topiramate
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA079153
Marketing category ANDA
Marketing start 2009-03-27
Marketing end 0000-00-00
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 2024-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A079153-001 TOPIRAMATE TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 A079153-002 TOPIRAMATE TOPIRAMATE 50MG TABLET / ORAL 2009-03-27 A079153-003 TOPIRAMATE TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 A079153-004 TOPIRAMATE TOPIRAMATE 200MG TABLET / ORAL 2009-03-27
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 A079153-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079153-002 TOPIRAMATE 50MG TABLET / ORAL 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079153-003 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079153-004 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079153-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079153-002 TOPIRAMATE 50MG TABLET / ORAL 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079153-003 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079153-004 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079153-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079153-002 TOPIRAMATE 50MG TABLET / ORAL 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079153-003 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079153-004 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079153-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079153-002 TOPIRAMATE 50MG TABLET / ORAL 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079153-003 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079153-004 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079153-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079153-002 TOPIRAMATE 50MG TABLET / ORAL 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079153-003 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079153-004 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079153-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079153-002 TOPIRAMATE 50MG TABLET / ORAL 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079153-003 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079153-004 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079153-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079153-002 TOPIRAMATE 50MG TABLET / ORAL 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079153-003 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079153-004 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079153-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079153-002 TOPIRAMATE 50MG TABLET / ORAL 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079153-003 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079153-004 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079153-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079153-002 TOPIRAMATE 50MG TABLET / ORAL 2009-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079153-003 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079153-004 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079153-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079153-002 TOPIRAMATE 50MG TABLET / ORAL 2009-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079153-003 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079153-004 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 d06236e962d9…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOPIRAMATE ACTIVE INGREDIENT 0H73WJJ391 TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 TOPIRAMATE ACTIVE INGREDIENT 0H73WJJ391 TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 TOPIRAMATE ACTIVE MOIETY 0H73WJJ391 TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 TOPIRAMATE ACTIVE MOIETY 0H73WJJ391 TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 TOPIRAMATE ACTIVE INGREDIENT 0H73WJJ391 TOPIRAMATE TABLET [STAT RX USA LLC] 3 TOPIRAMATE ACTIVE INGREDIENT 0H73WJJ391 TOPIRAMATE TABLET [DIRECT RX] 3 TOPIRAMATE ACTIVE INGREDIENT 0H73WJJ391 TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] 3 TOPIRAMATE ACTIVE MOIETY 0H73WJJ391 TOPIRAMATE TABLET [DIRECT RX] 3 TOPIRAMATE ACTIVE MOIETY 0H73WJJ391 TOPIRAMATE TABLET [STAT RX USA LLC] 3 TOPIRAMATE ACTIVE MOIETY 0H73WJJ391 TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPIRAMATE TABLET [STAT RX USA LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPIRAMATE TABLET [DIRECT RX] 3 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] 3 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TOPIRAMATE TABLET [DIRECT RX] 3 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TOPIRAMATE TABLET [STAT RX USA LLC] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TOPIRAMATE TABLET [DIRECT RX] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TOPIRAMATE TABLET [STAT RX USA LLC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPIRAMATE TABLET [STAT RX USA LLC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPIRAMATE TABLET [DIRECT RX] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TOPIRAMATE TABLET [STAT RX USA LLC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TOPIRAMATE TABLET [DIRECT RX] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPIRAMATE TABLET [STAT RX USA LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPIRAMATE TABLET [DIRECT RX] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ TOPIRAMATE TABLET [DIRECT RX] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ TOPIRAMATE TABLET [STAT RX USA LLC] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TOPIRAMATE TABLET [STAT RX USA LLC] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TOPIRAMATE TABLET [DIRECT RX] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPIRAMATE TABLET [DIRECT RX] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPIRAMATE TABLET [STAT RX USA LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPIRAMATE TABLET [STAT RX USA LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPIRAMATE TABLET [DIRECT RX] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] 3
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 13668-032-05 13668003205 500 TABLET in 1 BOTTLE (13668-032-05) 500 tablet 2009-03-27 0000-00-00 No No Current