Home NDC 68382-004 topiramate
Product NDC 68382-004
11-digit product format 683820004
Labeler code 68382
Product ID 68382-004_69df5f84-1db1-4eb2-ae32-462137a4d812
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name topiramate
Dosage form CAPSULE, COATED PELLETS
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA078877
Marketing category ANDA
Marketing start 2009-10-14
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 2027-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078877-001 TOPIRAMATE TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 A078877-002 TOPIRAMATE TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 A078877-003 TOPIRAMATE TOPIRAMATE 50MG CAPSULE / ORAL AB 2024-10-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 3 · 97 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 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2024-10-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2024-10-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2024-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2024-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2024-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL 2024-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL 2024-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL 2024-10-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL 2024-10-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078877-003 TOPIRAMATE 50MG CAPSULE / ORAL 2024-10-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078877-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2009-10-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078877-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2009-10-14 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 92 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOPIRAMATE 15 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205315 Internal RxNorm lookup 205316 Internal RxNorm lookup 252413 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 68382-004-01 topiramate 100 in 1 BOTTLE CAPSULE, COATED PELLETS 100 27 68382-004-05 topiramate 500 in 1 BOTTLE CAPSULE, COATED PELLETS 500 27 68382-004-10 topiramate 1000 in 1 BOTTLE CAPSULE, COATED PELLETS 1000 27 68382-004-14 topiramate 60 in 1 BOTTLE CAPSULE, COATED PELLETS 60 27 68382-004-16 topiramate 90 in 1 BOTTLE CAPSULE, COATED PELLETS 90 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOPIRAMATE ACTIVE INGREDIENT 0H73WJJ391 TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.] 11 TOPIRAMATE ACTIVE MOIETY 0H73WJJ391 TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.] 11 CELLULOSE ACETATE INACTIVE INGREDIENT 3J2P07GVB6 TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.] 11 GELATIN INACTIVE INGREDIENT 2G86QN327L TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.] 11 POVIDONE INACTIVE INGREDIENT FZ989GH94E TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.] 11 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.] 11 SUCROSE INACTIVE INGREDIENT C151H8M554 TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.] 11 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-004 TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS USA INC.] 26 Current NDC, Legacy NDC, 5 package rows 20250419_e4886adf-199d-4b19-a4ef-75f8f94cb54e.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 · 3 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 68382-004-01 68382000401 100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-01) 2009-10-14 0000-00-00 No No Current 68382-004-05 68382000405 500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-05) 2009-10-14 0000-00-00 No No Current 68382-004-10 68382000410 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-10) 2009-10-14 0000-00-00 No No Current 68382-004-14 68382000414 60 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-14) 2009-10-14 0000-00-00 No No Current 68382-004-16 68382000416 90 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-16) 2009-10-14 0000-00-00 No No Current