United States · FDA National Drug Code directory

Topiramate

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
68382-358_2535bcc8-fac7-4b15-8c6f-fd6675655fd3
Product NDC
68382-358
Form
CAPSULE, EXTENDED RELEASE
Composition / generic term
Topiramate
Labeler
Zydus Pharmaceuticals USA Inc.
Marketing category
ANDA
Marketing start / end (source format)
20231113
Source listing expiry
20271231

Source-listed ingredients

  • TOPIRAMATE — 200 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-01) · 68382-358-01
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-05) · 68382-358-05
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-06) · 68382-358-06
  • 3 BLISTER PACK in 1 CARTON (68382-358-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-358-30) · 68382-358-78

Source and coverage

Open FDA National Drug Code directory

Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

Browse United States records →