Home NDC 63304-778 Topiramate
Product NDC 63304-778
11-digit product format 633040778
Labeler code 63304
Product ID 63304-778_831ec733-ecc5-4461-a462-0dbc11811df1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topiramate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ranbaxy Pharmaceuticals Inc
Application ANDA076327
Marketing category ANDA
Marketing start 2010-01-04
Marketing end 0000-00-00
Substance TOPIRAMATE
Active strength 25 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
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 2 · 63 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A076327-001 TOPIRAMATE TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 A076327-002 TOPIRAMATE TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 A076327-003 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 4 · 129 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 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076327-002 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076327-003 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076327-002 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076327-003 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076327-002 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076327-003 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076327-002 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076327-003 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076327-002 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076327-003 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076327-002 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076327-003 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076327-002 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076327-003 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076327-002 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076327-003 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076327-002 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076327-003 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076327-002 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076327-003 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076327-002 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076327-003 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076327-002 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076327-003 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076327-002 TOPIRAMATE 100MG TABLET / ORAL 2009-03-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076327-003 TOPIRAMATE 200MG TABLET / ORAL 2009-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076327-001 TOPIRAMATE 25MG TABLET / ORAL 2009-03-27 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOPIRAMATE ACTIVE INGREDIENT 0H73WJJ391 TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5 TOPIRAMATE ACTIVE MOIETY 0H73WJJ391 TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-778 TOPIRAMATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] 5 Legacy NDC 20141203_7f3d81cc-caec-47a0-b703-fdff6fbc3f6f.zip