Quick answers
- What is Sumatriptan used for?
- The FDA-approved label (Imitrex, GlaxoSmithKline LLC, December 9, 2025) says: “IMITREX tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: • Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with IMITREX, reconsider the diagnosis of migraine before IMITREX is administered to treat any subsequent attacks. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sumatriptan have a boxed warning?
- No. None of the 84 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sumatriptan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sumatriptan been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Sumatriptan?
- 41 companies list prescription products of Sumatriptan in the FDA NDC Directory, including Proficient Rx LP, A-S Medication Solutions and NuCare Pharmaceuticals, Inc..
What Sumatriptan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
IMITREX tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: • Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with IMITREX, reconsider the diagnosis of migraine before IMITREX is administered to treat any subsequent attacks. …
— FDA label: Imitrex, GlaxoSmithKline LLC, effective December 9, 2025. Read the full label on DailyMed →
The FDA has 84 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.
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 84 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated · Injection · Injection, solution · Spray · Solution |
|---|---|
| Route | Oral · Subcutaneous · Nasal |
| Prescription products | 117 in the FDA NDC Directory |
| Brand names | Imitrex, Tosymra, Zembrace Symtouch |
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 |
|---|---|---|
| sumatriptan 10 mg/0.1 mL spray | Brand: Tosymra | $108.16 per unit |
| sumatriptan 20 mg spray | Generic | $15.63 per unit |
| sumatriptan 20 mg/0.1 mL spray | Generic | $15.63 per unit |
| sumatriptan 20 mg/100 uL spray | Generic | $15.63 per unit |
| sumatriptan 5 mg spray | Generic | $18.05 per unit |
| sumatriptan 5 mg/0.1 mL spray | Generic | $18.05 per unit |
| sumatriptan 5 mg/100 uL spray | Generic | $18.05 per unit |
| sumatriptan succinate 100 mg tablet | Generic | $0.4378 per tablet |
| sumatriptan succinate 100 mg tablet, film coated | Generic | $0.4378 per tablet |
| sumatriptan succinate 100 mg tablet, film coated | Brand: Imitrex | $72.36 per tablet |
| sumatriptan succinate 25 mg tablet | Generic | $0.2535 per tablet |
| sumatriptan succinate 25 mg tablet, film coated | Generic | $0.2535 per tablet |
| sumatriptan succinate 3 mg/0.5 mL solution | Brand: Zembrace SymTouch | $384.09 per mL |
| sumatriptan succinate 4 mg/0.5 mL injection | Brand: Imitrex | $463.54 per mL |
| sumatriptan succinate 50 mg tablet | Generic | $0.3126 per tablet |
| sumatriptan succinate 50 mg tablet, film coated | Generic | $0.3126 per tablet |
| sumatriptan succinate 6 mg/0.5 mL injection | Generic | $14.38–$59.41 per mL 7 packages, lowest to highest |
| sumatriptan succinate 6 mg/0.5 mL injection | Brand: Imitrex | $436.25–$459.40 per mL 2 packages, lowest to highest |
| sumatriptan succinate 6 mg/0.5 mL injection, solution | Generic | $14.38–$59.41 per mL 5 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on 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 LP12 products
- A-S Medication Solutions8 products
- NuCare Pharmaceuticals, Inc.8 products
- GlaxoSmithKline LLC6 products
- Sportpharm LLC5 products
- Preferred Pharmaceuticals Inc.5 products
- Asclemed USA, Inc.4 products
- NorthStar Rx LLC4 products
- Golden State Medical Supply, Inc.4 products
- Dr. Reddy's Laboratories Limited4 products
- Sun Pharmaceutical Industries, Inc.4 products
- Direct_Rx4 products
- Onesource Specialty Pharma Limited4 products
- Bionpharma Inc.3 products
- Aurobindo Pharma Limited3 products
- Mylan Pharmaceuticals Inc.3 products
- Rising Pharma Holdings, Inc.3 products
- Eugia US LLC2 products
- Alembic Pharmaceuticals Inc.2 products
- Alembic Pharmaceuticals Limited2 products
- Advanced Rx of Tennessee, LLC2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Tonix Medicines, Inc.2 products
- Lannett Company, Inc.2 products
- Prasco Laboratories2 products
- Padagis Israel Pharmaceuticals Ltd2 products
- Bryant Ranch Prepack2 products
- Armas Pharmaceuticals Inc.1 product
- Quality Care Products, LLC1 product
- Baxter Healthcare Corporation1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Strides Pharma Science Limited1 product
- Dr.Reddys Laboratories Inc1 product
- Caplin Steriles Limited1 product
- Remedyrepack Inc.1 product
- Fresenius Kabi USA, LLC1 product
- Somerset Therapeutics, LLC1 product
- Xellia Pharmaceuticals USA LLC1 product
- Florida Pharmaceutical Products, LLC1 product
- Upsher-Smith Laboratories, LLC1 product
- Cipla USA Inc.1 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 |
|---|---|---|---|
| NDA020080 IMITREX, IMITREX STATDOSE (AUTOINJECTOR) | Glaxosmithkline | December 28, 1992 | 30, latest December 9, 2025 2025: Labeling · 2021: Labeling · 2021: Labeling |
| NDA020132 IMITREX | Glaxosmithkline | June 1, 1995 | 22, latest December 9, 2025 2025: Labeling · 2021: Labeling · 2017: Labeling |
| NDA020626 IMITREX | Glaxosmithkline | August 26, 1997 | 15, latest December 9, 2025 2025: Labeling · 2017: Labeling · 2016: Manufacturing (CMC) |
| NDA208223 ZEMBRACE SYMTOUCH (AUTOINJECTOR) | Tonix Meds | January 28, 2016 | 2, latest June 10, 2019 2019: Efficacy · 2017: Labeling |
| NDA210884 TOSYMRA | Tonix Meds | January 25, 2019 | — |
Generic approvals (25)
- ANDA078593Wockhardt Bio AG · February 6, 2009
- ANDA076572Sun Pharm Inds Ltd · February 9, 2009
- ANDA079242Fresenius Kabi USA · March 2, 2009
- ANDA076554Sun Pharm Inds Ltd · August 10, 2009
- ANDA076847DR Reddys Labs Inc · August 10, 2009
- ANDA077744Mylan · August 10, 2009
- ANDA078284Orbion Pharms · August 10, 2009
- ANDA078295Sun Pharm Inds · August 10, 2009
- ANDA078327Aurobindo Pharma · August 10, 2009
- ANDA090314Onesource Specialty · June 10, 2010
- ANDA090641Onesource Specialty · July 28, 2010
- ANDA090358Sun Pharm · June 21, 2011
- ANDA202758Eugia Pharma · April 23, 2013
- ANDA200183Hikma · September 16, 2013
- ANDA090495DR Reddys · January 29, 2014
- ANDA204841Lannett Co Inc · February 19, 2016
- ANDA213465Padagis Israel · September 21, 2020
- ANDA213650Perrigo Uk Finco · September 21, 2020
- ANDA208967Regcon Holdings · February 17, 2021
- ANDA214209Cipla · February 22, 2021
- ANDA213998Caplin · July 13, 2021
- ANDA207101Baxter Hlthcare Corp · January 19, 2023
- ANDA215651Onesource Specialty · November 21, 2024
- ANDA219036Vkt Pharma · December 31, 2024
- ANDA213518Alembic · November 6, 2025
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.
-
April 13, 2022 · Class II · Terminated · D-1111-2022
cGMP deviations: Temperature abuse
Sumatriptan Succinate Tablets, 100 mg, 9 (1 x 9) Unit-of- use tablets box, Rx only, MFG: Sun Pharmaceuticals, NDC 62756-522-69 — Mckesson Medical-Surgical Inc. Corporate Office
-
December 26, 2019 · Class II · Terminated · D-0659-2020
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 count bottles, (NDC 62756-521-88), Rx only, Sun Pharma, Cranbury, NJ — Sun Pharmaceutical Industries, Inc.
-
November 6, 2013 · Class II · Terminated · D-387-2014
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1 carrying case, Rx o — GlaxoSmithKline, LLC.
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) | 208450, 209169, 284460, 313159, 313160, 313161, 313165, 314227, 315223, 401978 … (+10) |
|---|---|
| SPL set ID of the quoted label | 584abe73-8290-4484-ff8e-5890831c095e |
| FDA labels (SPL) | 84 |
| FDA applications | NDA020080, NDA020132, NDA020626, NDA208223, NDA210884, 25 ANDA |
| Active ingredients (FDA) | SUMATRIPTAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Imitrex, GlaxoSmithKline LLC, effective December 9, 2025; 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 →