Home NDC 27241-300 Topiramate
Product NDC 27241-300
11-digit product format 272410300
Labeler code 27241
Product ID 27241-300_27efc40f-ad43-440f-936b-7013d92b56fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topiramate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Ajanta Pharma USA Inc.
Application ANDA219564
Marketing category ANDA
Marketing start 2025-09-02
Substance TOPIRAMATE
Active strength 200 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 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219564-001 TOPIRAMATE TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 A219564-002 TOPIRAMATE TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 A219564-003 TOPIRAMATE TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 A219564-004 TOPIRAMATE TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 A219564-005 TOPIRAMATE TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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.
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 A219564-001 TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219564-002 TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219564-003 TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219564-004 TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219564-005 TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219564-001 TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219564-002 TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219564-003 TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219564-004 TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219564-005 TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219564-001 TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219564-002 TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219564-003 TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219564-004 TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219564-005 TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2025-09-02 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Topiramate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOPIRAMATE 200 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1494769 Internal RxNorm lookup 1812419 Internal RxNorm lookup 1812421 Internal RxNorm lookup 1812425 Internal RxNorm lookup 1812427 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 27241-300-30 Topiramate 30 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 30 5
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 Marketing start Sample Exclude flag Status 27241-300-30 27241030030 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-300-30) 2025-09-02 No No Current