The short version
5 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
topiramate
topiramate · TOPIRAMATE 50 mg/1 · Capsule, Coated Pellets · Oral · Zydus Lifesciences Limited
NDC 65841-0846-14 · 60 CAPSULE, COATED PELLETS in 1 BOTTLE · ANDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 68382-0498-14) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
Data sources
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method
Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
Plans pay at point of saleⓘ
$4.31per unit
middle half $4.05–$4.64 · 4,319 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $4.31
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
79%of plans cover it
tier 2 · prior auth 6% · step therapy 0% · qty limit 0%
*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 5 quarters since 2024.
NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for topiramate (oral solid) in the next 90 days
OAI inspection at a producing facility (24 months) · sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- analysis · manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA078877
- TE code
- AB
- Approval date
- Oct 14, 2009
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of topiramate (Capsule, Coated Pellets)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USA | TOPIRAMATE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc., USA | TOPIRAMATE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Janssen Pharmaceuticals, Inc. | TOPIRAMATE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Janssen Pharmaceuticals, Inc. | TOPIRAMATE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Remedyrepack Inc. | TOPIRAMATE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | TOPIRAMATE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | TOPIRAMATE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | TOPIRAMATE 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | TOPIRAMATE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | TOPIRAMATE 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | TOPIRAMATE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "topiramate — NDC 65841-0846-14," retrieved September 3, 2026, https://drugdashboards.com/drug/65841084614.
Free to cite with attribution — see how the data is put together.