Quick answers
- What is Topiramate used for?
- The FDA-approved label (Qudexy XR, Upsher-Smith Laboratories, LLC, September 3, 2026) says: “QUDEXY XR is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older Preventive treatment of migraine in patients 12 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Topiramate have a boxed warning?
- No. None of the 143 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Topiramate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Topiramate been recalled?
- FDA enforcement reports list 9 recalls of products of this medicine; the newest started August 31, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Topiramate?
- 48 companies list prescription products of Topiramate in the FDA NDC Directory, including Proficient Rx LP, Bryant Ranch Prepack and Zydus Pharmaceuticals USA Inc..
What Topiramate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
QUDEXY XR is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older Preventive treatment of migraine in patients 12 …
— FDA label: Qudexy XR, Upsher-Smith Laboratories, LLC, effective September 3, 2026. Read the full label on DailyMed →
The FDA has 143 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 143 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Capsule, extended release · Tablet · Capsule, coated pellets · Capsule · Solution · Tablet, coated |
|---|---|
| Route | Oral |
| Prescription products | 302 in the FDA NDC Directory |
| Brand names | Topamax, Qudexy XR, Trokendi XR, Eprontia |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| topiramate 100 mg capsule, extended release | Generic | $5.78–$9.10 per capsule 12 packages, lowest to highest |
| topiramate 100 mg capsule, extended release | Brand: Trokendi XR | $34.44 per capsule |
| topiramate 100 mg tablet | Generic | $0.0593 per tablet |
| topiramate 100 mg tablet, coated | Brand: Topamax | $17.92 per tablet |
| topiramate 100 mg tablet, film coated | Generic | $0.0593 per tablet |
| topiramate 15 mg capsule | Generic | $0.2314 per capsule |
| topiramate 15 mg capsule, coated pellets | Generic | $0.2314 per capsule |
| topiramate 150 mg capsule, extended release | Generic | $7.03 per capsule |
| topiramate 200 mg capsule, extended release | Generic | $9.89–$17.41 per capsule 12 packages, lowest to highest |
| topiramate 200 mg capsule, extended release | Brand: Trokendi XR | $47.14 per capsule |
| topiramate 200 mg tablet | Generic | $0.1089 per tablet |
| topiramate 200 mg tablet, coated | Brand: Topamax | $21.07 per tablet |
| topiramate 200 mg tablet, film coated | Generic | $0.1089 per tablet |
| topiramate 25 mg capsule | Generic | $0.2445 per capsule |
| topiramate 25 mg capsule, coated pellets | Generic | $0.2445 per capsule |
| topiramate 25 mg capsule, coated pellets | Brand: Topamax | $7.54 per capsule |
| topiramate 25 mg capsule, extended release | Generic | $2.23–$3.66 per capsule 12 packages, lowest to highest |
| topiramate 25 mg capsule, extended release | Brand: Trokendi XR | $13.30 per capsule |
| topiramate 25 mg tablet | Generic | $0.0272 per tablet |
| topiramate 25 mg tablet, coated | Brand: Topamax | $6.58 per tablet |
| topiramate 25 mg tablet, film coated | Generic | $0.0272 per tablet |
| topiramate 25 mg/mL solution | Generic | $1.08–$2.09 per mL 2 packages, lowest to highest |
| topiramate 25 mg/mL solution | Brand: Eprontia | $1.58–$2.72 per mL 3 packages, lowest to highest |
| topiramate 50 mg capsule | Generic | $4.29 per capsule |
| topiramate 50 mg capsule, coated pellets | Generic | $4.29 per capsule |
| topiramate 50 mg capsule, extended release | Generic | $3.24–$5.67 per capsule 12 packages, lowest to highest |
| topiramate 50 mg capsule, extended release | Brand: Trokendi XR | $17.43 per capsule |
| topiramate 50 mg tablet | Generic | $0.0397 per tablet |
| topiramate 50 mg tablet, coated | Brand: Topamax | $13.13 per tablet |
| topiramate 50 mg tablet, film coated | Generic | $0.0397 per tablet |
NADAC list of November 4, 2026; these prices took effect between July 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Proficient Rx LP18 products
- Bryant Ranch Prepack17 products
- Zydus Pharmaceuticals USA Inc.16 products
- Remedyrepack Inc.16 products
- Zydus Lifesciences Limited16 products
- A-S Medication Solutions13 products
- Upsher-Smith Laboratories, LLC12 products
- Glenmark Pharmaceuticals Inc., USA11 products
- Ajanta Pharma USA Inc.9 products
- Camber Pharmaceuticals, Inc.8 products
- PD-Rx Pharmaceuticals, Inc.8 products
- Ascend Laboratories, LLC8 products
- Preferred Pharmaceuticals Inc.8 products
- Cipla USA Inc.8 products
- Sun Pharmaceutical Industries, Inc.8 products
- Advanced Rx Pharmacy of Tennessee, LLC6 products
- Janssen Pharmaceuticals, Inc.6 products
- Coupler LLC6 products
- Aurobindo Pharma Limited6 products
- NuCare Pharmaceuticals, Inc.6 products
- Vitruvias Therapeutics, Inc.5 products
- Cranbury Pharmaceuticals, LLC5 products
- Northwind Health Company, LLC5 products
- NorthStar RxLLC5 products
- XLCare Pharmaceuticals, Inc.4 products
- Exelan Pharmaceuticals Inc.4 products
- Asclemed USA, Inc.4 products
- Par Health USA, LLC4 products
- Supernus Pharmaceuticals, Inc.4 products
- Lupin Pharmaceuticals, Inc.4 products
- AvKARE4 products
- St. Mary's Medical Park Pharmacy4 products
- Teva Pharmaceuticals, Inc.4 products
- Unichem Pharmaceuticals (USA), Inc.4 products
- Dr.Reddys Laboratories Inc4 products
- American Health Packaging4 products
- Advanced Rx of Tennessee, LLC4 products
- AvPAK4 products
- Aphena Pharma Solutions - Tennessee, LLC4 products
- Advagen Pharma Ltd3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- Quallent Pharmaceuticals Health LLC3 products
- Cardinal Health 107, LLC2 products
- Major Pharmaceuticals2 products
- Kesin Pharma1 product
- Unit Dose Solutions, Inc.1 product
- Azurity Pharmaceuticals, Inc.1 product
- c1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020505 TOPAMAX | Janssen Pharms | December 24, 1996 | 52, latest March 6, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
| NDA020844 TOPAMAX, TOPAMAX SPRINKLE | Janssen Pharms | October 26, 1998 | 48, latest March 6, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
| NDA201635 TROKENDI XR | Supernus Pharms | August 16, 2013 | 20, latest March 6, 2026 2026: Labeling · 2025: Labeling · 2024: Labeling |
| NDA205122 QUDEXY XR | Upsher Smith Labs | March 11, 2014 | 12, latest March 6, 2026 2026: Labeling · 2025: Labeling · 2024: Labeling |
| NDA214679 EPRONTIA | Azurity | November 5, 2021 | 4, latest March 6, 2026 2026: Labeling · 2025: Labeling · 2024: Labeling |
Generic approvals (28)
- ANDA076343Cipla Ltd · March 27, 2009
- ANDA077627Glenmark Pharms Ltd · March 27, 2009
- ANDA078235Zydus Pharms USA Inc · March 27, 2009
- ANDA078462Aurobindo Pharma · March 27, 2009
- ANDA079162Invagen Pharms · March 27, 2009
- ANDA090162Unichem Labs Ltd · March 27, 2009
- ANDA090278Sun Pharm · March 27, 2009
- ANDA078877Zydus Pharms USA Inc · October 14, 2009
- ANDA207382Zydus · November 24, 2017
- ANDA210278Glenmark Pharms Ltd · February 1, 2021
- ANDA215414Ascent Pharms Inc · August 26, 2021
- ANDA208949Zydus · November 28, 2022
- ANDA205976Ph Health · March 1, 2023
- ANDA206210Actavis Labs Fl · March 10, 2023
- ANDA217248Alkem Labs Ltd · June 20, 2023
- ANDA215663Ajanta Pharma Ltd · August 15, 2023
- ANDA215449Aurobindo Pharma Ltd · September 27, 2023
- ANDA217231DR Reddys · November 17, 2023
- ANDA217694Twi Pharms · December 5, 2023
- ANDA218482Alkem Labs Ltd · June 13, 2024
- ANDA215561Lupin · July 11, 2024
- ANDA217869Glenmark Pharms Ltd · July 16, 2024
- ANDA217795Alkem Labs Ltd · October 31, 2024
- ANDA215638Xiamen LP Pharm Co · November 5, 2024
- ANDA218695Amta · December 3, 2024
- ANDA216683Rubicon Research · May 27, 2025
- ANDA219564Ajanta Pharma Ltd · September 2, 2025
- ANDA217443Ascent Pharms Inc · January 12, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 31, 2026 · Class III · Ongoing · D-0833-2026
Failed dissolution specifications.
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 2085 — Supernus Pharmaceuticals, Inc.
-
July 6, 2026 · Class III · Ongoing · D-0758-2026
Failed Dissolution Specifications
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 U — Supernus Pharmaceuticals, Inc.
-
December 8, 2023 · Class III · Terminated · D-0213-2024
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1 — Azurity Pharmaceuticals, Inc.
-
October 25, 2021 · Class III · Terminated · D-0255-2022
Discoloration
Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswi — UNICHEM PHARMACEUTICALS USA INC
-
March 15, 2021 · Class II · Terminated · D-0570-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, — Cardinal Health Inc.
-
July 12, 2016 · Class II · Terminated · D-0112-2017
Superpotent Drug: Failure of assay specifications in the capsule.
Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 2 — Supernus Pharmaceuticals, Inc.
-
September 15, 2014 · Class II · Terminated · D-0015-2015
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14. — Zydus Pharmaceuticals USA Inc
-
April 5, 2013 · Class III · Terminated · D-331-2013
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430 — Glenmark Generics Inc., USA
-
July 25, 2012 · Class III · Terminated · D-1645-2012
Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".
Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd., Ahmedabad, India; Dist By: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, Pkg by: American Heal — American Health Packaging
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 151226, 199888, 199889, 199890, 205315, 205316, 252413, 1436239, 1437278, 1437283 … (+10) |
|---|---|
| SPL set ID of the quoted label | 46f54677-3a22-4c38-9b92-923020164e15 |
| FDA labels (SPL) | 143 |
| FDA applications | NDA020505, NDA020844, NDA201635, NDA205122, NDA214679, 28 ANDA |
| Active ingredients (FDA) | TOPIRAMATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Qudexy XR, Upsher-Smith Laboratories, LLC, effective September 3, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →