Baclofen 5 mg Tablet, 50-count
Other active recalls for Baclofen (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the gamma-Aminobutyric Acid-ergic Agonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Baclofen is used to treat pain and certain types of spasticity (muscle stiffness and tightness) from multiple sclerosis, spinal cord injuries, or other spinal cord diseases. Baclofen is in a class of medications called skeletal muscle relaxants. Baclofen acts on the spinal cord nerves and decreases the number and severity of muscle spasms caused by multiple sclerosis or spinal cord conditions. It also relieves pain and improves muscle movement.
Read the full MedlinePlus article ↗- Baclofen is prescribed to reduce spasticity — the muscle stiffness, spasms, and rigidity that come with conditions like multiple sclerosis or spinal cord injury. Oral forms are als...
- What exactly is baclofen being used to treat — and will it help my pain too?
- Yes, and this is really important. Stopping baclofen suddenly — especially the pump form — can cause a dangerous withdrawal reaction: your spasticity can return much worse than bef...
- I heard you can't just stop taking baclofen — is that really true?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Baclofen — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
-
UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.068 | $3.42 / 50 tablet |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1147 | $5.74 / 50 tablet |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Baclofen 5 mg 00527-1333-01 | Lannett | 100 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 00904-7558-06 | Major | 50 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 16571-0169-01 | Rising | 100 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 29300-0474-01 | Unichem | 100 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 50268-0105-15 | AvPAK | 50 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 52817-0319-10 | TruPharma | 100 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 58657-0730-01 | Method | 100 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 58657-0930-01 | Method | 100 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mgthis 60687-0804-65 | American | 50 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 62135-0472-90 | Chartwell | 90 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 70710-1609-01 | Zydus | 100 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 70756-0085-11 | Lifestar | 100 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 71930-0066-12 | Eywa | 100 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 72888-0009-01 | Advagen | 100 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 00615-8518-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Baclofen 5 mg 42571-0427-01 | Micro | 100 tablets | — | AB | Discontinued | — |
| Baclofen 5 mg 51407-0972-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Baclofen 5 mg 55154-4349-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Baclofen 5 mg 70518-4656-00 | REMEDYREPACK | 14 tablets | — | AB | FDA listed | — |
| Baclofen 5 mg 70771-1586-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Baclofen 5 mg 71335-3050-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Baclofen 5 mg 71335-3051-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Baclofen 5 mg 72162-2372-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Baclofen 5 mg 72162-2448-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Baclofen 5 mg 72789-0478-01 | PD-Rx | 100 tablets | — | AB | FDA listed | — |
| Baclofen 5 mg 72865-0296-01 | XLCare | 100 tablets | — | AB | FDA listed | — |
| Baclofen 5 mg 76420-0356-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Baclofen 5 mg 82804-0219-90 | Proficient | 90 tablets | — | AB | FDA listed | — |
| Baclofen 5 mg 84386-0035-93 | Aurobindo | 9000 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 60687-0804-65 You're viewing this | 50 BLISTER PACK in 1 CARTON (60687-804-65) / 1 TABLET in 1 BLISTER PACK (60687-804-11) | 2024-05-26 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Baclofen 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. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 mg to 80 mg daily). The following dosage titration schedule is suggested: 5 mg t.i.d.
(three times in a day) for 3 days 10 mg t.i.d. for 3 days 15 mg t.i.d. for 3 days 20 mg t.i.d. for 3 days Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d. (four times in a day)). The lowest dose compatible with an optimal response is recommended.
If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal ).
⛔ Contraindications ▾
CONTRAINDICATIONS Hypersensitivity to baclofen.
⚠️ Warnings ▾
WARNINGS Neonatal Withdrawal Symptoms: Withdrawal symptoms have been reported starting hours to days after delivery in neonates whose mothers were treated with oral baclofen throughout pregnancy. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure. If the potential benefit justifies the potential risk to the fetus and oral baclofen is continued during pregnancy, gradually reduce the dose and discontinue baclofen before delivery.
If slow withdrawal is not feasible, advise the parents or caregivers of the potential for neonatal withdrawal. Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.
Impaired Renal Function: Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage. Stroke: Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.
Pregnancy: Baclofen has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits. There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose.
In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 and 34 times the human daily dose. There are no studies in pregnant women. Baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The most common is transient drowsiness (10 to 63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5 to 15%), weakness (5 to 15%) and fatigue (2 to 4%).
Others reported: Neuropsychiatric: Confusion (1 to 11%), headache (4 to 8%), insomnia (2 to 7%); and, rarely, euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure. Cardiovascular: Hypotension (0 to 9%). Rare instances of dyspnea, palpitation, chest pain, syncope.
Gastrointestinal: Nausea (4 to 12%), constipation (2 to 6%); and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool. Genitourinary: Urinary frequency (2 to 6%); and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria. Other: Instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion.
Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy. The following laboratory tests have been found to be abnormal in a few patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar. To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🆘 Overdosage ▾
OVERDOSAGE Signs and Symptoms: Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression and seizures. Treatment: In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The precise mechanism of action of baclofen is not fully known. Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although baclofen is an analog of the putative inhibitory neurotransmitter gamma-aminobutyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects.
In studies with animals baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Baclofen is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses.
Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Baclofen Tablets USP, 5 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablets debossed with "16" on one side and "09" on the other side, containing 5 mg baclofen, USP are supplied as follows: Unit dose packages of 50 (5 x 10) NDC 60687-804-65 Baclofen Tablets USP, 10 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablet debossed with "1285" on one side and break line on the other side, containing 10 mg baclofen, USP are supplied as follows: Unit dose packages of 50 (5 x 10) NDC 60687-815-65 Unit dose packages of 100 (10 x 10) NDC 60687-815-01 Baclofen Tablets USP, 20 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablet debossed with "1286" on one side and break line on the other side, containing 20 mg baclofen, USP are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 60687-826-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn or broken. Keep this and all drugs out of the reach of children.
📋 Description ▾
DESCRIPTION Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is: C 10 H 12 ClNO 2 M.W.
213.66 Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP.
In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, povidone and sodium starch glycolate. Structural Formula