Prescription medicine
Baclofen Brand names: Lioresal, Gablofen, Lyvispah, Fleqsuvy, Ozobax
Baclofen (Gablofen) is a prescription medicine with an FDA approval on record since 1977. FDA's NDC Directory lists it from 55 generic labelers, and pharmacies paid $0.032 per baclofen 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the baclofen FDA label on DailyMed (effective August 12, 2024, Zydus Lifesciences Limited); the NDA 17851 record on Drugs@FDA; every baclofen label on DailyMed.
Highlights of the record
FDA label of August 12, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBaclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Forms and strengths
- 5 mg
- 10 mg
- 15 mg
- 20 mg
- 0.05 mg/ml
- 5 mg/ml
- 5 mg/5ml
- 10 mg/5ml
Tablet; injection; injection (solution); solution; kit.
On the market
- Earliest approval on file
- November 22, 1977 Lioresal, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 40 first July 21, 1988; 26 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 64 of which 55 under generic applications, 5 under brand applications, repackagers included
- Last listed patent
- September 29, 2041 Lyvispah granule; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.032 per tablet Baclofen 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2012 0 Class I among all firms' recalls; latest November 26, 2025; 9 more by firms not listed as its makers
- FAERS reports
- 88,351 through July 30, 2026
What is baclofen used for?
From the label: indications and usageBaclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. […]
Conditions named in the indications of baclofen's FDA labels, with every medicine labeled for each:
From other baclofen labelsMuscle spasms and spasticity: INDICATIONS AND USAGE Baclofen injection (intrathecal) is indicated for use in the management of severe spasticity.
FDA pharmacologic class: gamma-Aminobutyric Acid-ergic Agonist.
Source: FDA drug label (Baclofen), Zydus Lifesciences Limited, effective August 12, 2024 (SPL set bb5c6faa-2933-44d1-8706-8302150be734), via openFDA; the full label on DailyMed
What does the patient leaflet for baclofen say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking LYVISPAH?Do not drive, operate dangerous machinery, or do any other dangerous activities until you know how LYVISPAH affects you. LYVISPAH can make you drowsy and less alert when you first start taking LYVISPAH and when your LYVISPAH dose is increased.
From the patient leaflet: How should I store LYVISPAH?Store LYVISPAH at room temperature between 68°F to 77°F (20°C to 25°C).
Source: FDA drug label (LYVISPAH), Amneal Pharmaceuticals LLC, effective April 23, 2023 (SPL set f8992a56-9010-4c4b-84d5-ddcc3e2c3317), via openFDA; the full label on DailyMed
Is there a generic for baclofen (Gablofen)?
The FDA approved the first generic baclofen on July 21, 1988. 40 generic applications are approved; 26 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists baclofen from 55 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Gablofen injection; a patent listed only for Lyvispah granule runs to September 29, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1977 earliest approval on file
- 1988 first generic approved
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for baclofen (Gablofen)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.032 per Baclofen 10 mg tablet, down 12% from $0.0365 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Baclofen 10 mg tablet (generic)
- Fleqsuvy 25 mg/5 mL suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Baclofen 10 mg tablet | Generic | $0.032 per tablet | $0.960 | -12% |
| Baclofen 10 mg/5 mL solution | Generic | $2.04 per mL | n/a | -18% |
| Baclofen 15 mg tablet | Generic | $1.67 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $50.00 | +4% |
| Baclofen 20 mg tablet | Generic | $0.0519 per tablet | $1.56 | -7% |
| Baclofen 25 mg/5 mL suspension | Generic | $3.78 per mL | n/a | -4% |
| Baclofen 5 mg tablet | Generic | $0.068 per tablet | $2.04 | -37% |
| Baclofen 5 mg/5 mL solution | Generic | $1.07 per mL | n/a | -2% |
| Fleqsuvy 25 mg/5 mL suspension | Brand | $5.98 per mL | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has baclofen been recalled?
The FDA's Enforcement Report lists 12 recalls naming baclofen since 2012: 0 Class I (the most serious), 12 Class II, 0 Class III; 1 still ongoing. 9 of them are by firms that FDA's NDC Directory does not list as a maker of baclofen and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 26, 2025 | Class II | Golden State Medical Supply Inc. | Presence of Foreign Tablets/Capsules |
| December 20, 2019 | Class II | Assurance Infusion not a listed maker | Lack of sterility assurance. |
| July 8, 2019 | Class II | Piramal Critical Care, Inc. | Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf … |
| February 9, 2018 | Class II | American Pharmaceutical Ingredients LLC not a listed maker | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. |
| February 4, 2016 | Class II | Hartley Medical Center Pharmacy, Incorporated not a listed maker | Lack of Assurance of Sterility |
| December 29, 2015 | Class II | TexasStar Pharmacy not a listed maker | Lack of assurance of sterility |
| December 24, 2015 | Class II | Amerita Specialty Infusion Services not a listed maker | Lack of Assurance of Sterility |
| November 9, 2015 | Class II | Freedom Pharmaceuticals Inc | Presence of Foreign Substance |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the baclofen label say about other medicines?
The baclofen label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name baclofen. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Morphine | drug interactions | Interactions attributed to the combined use of LIORESAL INTRATHECAL and epidural morphine include hypotension and dyspnea. |
Source: FDA drug label (Baclofen), Zydus Lifesciences Limited, effective August 12, 2024 (SPL set bb5c6faa-2933-44d1-8706-8302150be734), via openFDA; the full label on DailyMed
What do FAERS reports show for baclofen?
The FDA Adverse Event Reporting System holds 88,351 reports that list baclofen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,567 are coded as a death and 28,758 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as baclofen?
8 other medicines are given the same way (oral) and in the same FDA class as baclofen or labeled mainly for the same use (muscle spasms and spasticity), the same class first. Muscle spasms and spasticity lists all 12 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cyclobenzaprine | Muscle spasms and spasticity | 60 labelers | $0.0171 per tablet 10 mg tablet | No current entry |
| Tizanidine | Muscle spasms and spasticity | 51 labelers | $0.0331 per tablet 4 mg tablet | No current entry |
| Methocarbamol | Muscle spasms and spasticity | 54 labelers | $0.0395 per tablet 500 mg tablet | No current entry |
| Metaxalone | Muscle spasms and spasticity | 33 labelers | $0.452 per tablet 800 mg tablet | No current entry |
| Carisoprodol | Muscle spasms and spasticity | 24 labelers | $0.0706 per tablet 350 mg tablet | No current entry |
| Chlorzoxazone | Muscle spasms and spasticity | 19 labelers | $0.210 per tablet 500 mg tablet | No current entry |
| Dantrolene | Muscle spasms and spasticity | 7 labelers | $0.409 per capsule 25 mg capsule | No current entry |
| Orphenadrine | Muscle spasms and spasticity | 14 labelers | $0.454 per tablet 100 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does baclofen compare with medicines for the same use?
10 side-by-side pages set baclofen beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to baclofen
- 8 medicines for the same use
- Other gamma-aminobutyric acid-ergic agonists
- the pharmacologic class, with prices and generics
- Baclofen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other