Topiramate

NDC 68382-863 · Zydus Pharmaceuticals USA Inc.

Generic nameTopiramate

Dosage formCAPSULE, EXTENDED RELEASE

RouteORAL

Active ingredient(s)TOPIRAMATE

Strength25 mg/1

Pharmacologic classCytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]

Marketing categoryANDA

Packages

68382-863-01 — 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-01)

68382-863-05 — 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-05)

68382-863-06 — 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-06)

68382-863-16 — 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-16)

68382-863-78 — 3 BLISTER PACK in 1 CARTON (68382-863-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-863-30)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

68084-345 — Topiramate, 68382-004 — topiramate, 68382-005 — topiramate, 68382-138 — topiramate, 68382-139 — topiramate, 68382-140 — topiramate, 68382-141 — topiramate, 68382-358 — Topiramate, 68382-498 — topiramate, 68382-769 — Topiramate, 68382-864 — Topiramate, 68462-108 — Topiramate, 68462-109 — Topiramate, 68462-110 — Topiramate, 68462-153 — Topiramate, 68462-218 — Topiramate, 68462-219 — Topiramate, 68462-370 — topiramate, 68462-371 — topiramate, 68462-372 — topiramate, +289 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q3 (July 2026 release). All data sources · How to read the labels