Home NDC 72888-228-60 Topiramate
Product NDC 72888-228
Requested package NDC 72888-228-60
11-digit product format 728880228
Labeler code 72888
Product ID 72888-228_4e8dd02d-2263-78d0-e063-6294a90a5f0b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topiramate
Dosage form CAPSULE
Route ORAL
Labeler Advagen Pharma Ltd
Application ANDA216683
Marketing category ANDA
Marketing start 2025-05-27
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 A216683-001 TOPIRAMATE TOPIRAMATE 15MG CAPSULE / ORAL AB 2025-05-27 A216683-002 TOPIRAMATE TOPIRAMATE 25MG CAPSULE / ORAL AB 2025-05-27 A216683-003 TOPIRAMATE TOPIRAMATE 50MG CAPSULE / ORAL AB 2025-05-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A216683-003 CGT 2026-02-01
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.
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 A216683-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2025-05-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216683-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2025-05-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216683-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2025-05-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216683-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2025-05-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216683-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2025-05-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216683-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2025-05-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216683-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2025-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216683-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2025-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216683-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2025-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216683-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2025-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216683-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2025-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216683-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2025-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216683-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2025-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216683-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2025-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216683-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2025-05-27 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216683-001 TOPIRAMATE 15MG CAPSULE / ORAL AB 2025-05-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216683-002 TOPIRAMATE 25MG CAPSULE / ORAL AB 2025-05-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216683-003 TOPIRAMATE 50MG CAPSULE / ORAL AB 2025-05-27 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 A216683-003 CGT 2026-02-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216683-003 CGT 2026-02-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216683-003 CGT 2026-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216683-003 CGT 2026-02-01 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216683-003 CGT 2026-02-01 a50c72e98297…
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 72888-228-05 Topiramate 500 in 1 BOTTLE CAPSULE 500 7 72888-228-12 Topiramate 120 in 1 BOTTLE CAPSULE 120 7 72888-228-30 Topiramate 30 in 1 BOTTLE CAPSULE 30 7 72888-228-60 Topiramate 60 in 1 BOTTLE CAPSULE 60 7 72888-228-67 Topiramate 240 in 1 BOTTLE CAPSULE 240 7
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72888-228-60 72888022860 60 CAPSULE in 1 BOTTLE (72888-228-60) 60 capsule 2025-05-27 No No Current