Home NDC 70710-1042-3 Topiramate
Product NDC 70710-1042
Requested package NDC 70710-1042-3
11-digit product format 707101042
Labeler code 70710
Product ID 70710-1042_bb736981-167f-4de6-a285-0e840ae37fc7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topiramate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA208949
Marketing category ANDA
Marketing start 2023-01-17
Substance TOPIRAMATE
Active strength 150 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 A208949-001 TOPIRAMATE TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2022-11-29 A208949-002 TOPIRAMATE TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2022-11-29 A208949-003 TOPIRAMATE TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2022-11-29 A208949-004 TOPIRAMATE TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2022-11-29 A208949-005 TOPIRAMATE TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2022-11-29
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 2026-08-01 22:54:32 2026-06 A208949-001 TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2022-11-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A208949-002 TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2022-11-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A208949-003 TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2022-11-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A208949-004 TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2022-11-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A208949-005 TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE / ORAL AB2 2022-11-29 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Topiramate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOPIRAMATE 150 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 70710-1042-3 Topiramate 30 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 30 7 70710-1042-9 Topiramate 90 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1042 TOPIRAMATE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] 6 Current NDC, 2 package rows 20250411_a5ca2fce-bd2d-40db-b963-e3ec27c8bf23.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70710-1042-3 70710104203 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1042-3) 2023-01-17 No No Current