Baclofen 5 mg Tablet, 100-count — NDC 58657-930-01 (Billing 58657-0930-01)
This is a package of 100 tablets of Baclofen 5 mg Tablet from Method Pharmaceuticals LLC, marketed since Jun 2024 and currently FDA-listed; retail pharmacies pay about $0.0680 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.
Other active recalls for Baclofen (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 027229
- GCN: 18012
- GPI-14 (Medi-Span): 75100010000303
- HICL (First Databank): 001949
- AHFS class code: 12:20.12.00
- RxCUI (RxNorm): 197391
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the gamma-Aminobutyric Acid-ergic Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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 ↗- It eases spasticity, meaning stiff, tight muscles and spasms. Oral forms are used mainly for spasticity from multiple sclerosis and may help with spinal cord injuries. Intrathecal...
- Oral baclofen is usually started low and split into several doses a day, then increased slowly. Follow your prescriber and label. With liquids, double-check both the mg and mL on y...
- Don't stop suddenly. Your dose should be lowered slowly. With an intrathecal pump, missing a refill can cause dangerous withdrawal, so keep every appointment.
- Sleepiness, dizziness, nausea, headache, low blood pressure and muscle weakness are common. Avoid driving until you know how it affects you, and avoid alcohol.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Baclofen — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $6.80 / 100 tablets |
| 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 | $11.47 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 58657-0930-01 You're viewing this Main listing | 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK | $0.0680 / ea | $6.80 | 2025-06-01 | — | Active |
| 58657-0930-05 58657-930-05 | 5 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK | $0.0680 / ea | $3.40 | 2025-06-01 | — | Active |
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0680 NADAC).
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 58657-0930-05?
What NDC number is used to bill for this package of Baclofen 5 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
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 mgthis 58657-0930-01 | Method | 100 tablets | $0.068 | AB | Availability likely | — |
| Baclofen 5 mg 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?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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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.
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UNII H92E6QA4FV
Zinc stearate is a fine white powder made from zinc and stearic acid. It works as a lubricant and glidant to help the tablet or capsule move smoothly through manufacturing equipment and prevents sticking.
4 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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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 to 80 mg daily). The following dosage titration schedule is suggested: 5 mg t.i.d. 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.).
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 a. 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. b. 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. c. 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. d. Stroke: Baclofen has not significantly benefited patients with stroke.
These patients have also shown poor tolerability to the drug. e. 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.
🆘 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 – white to off-white, round, flat tablet with bevel edge, debossed “167” on one side and “I” on the other side. Bottles of 100………………....…………………………………...……. NDC 58657-730-01 Bottles of 1000………………...….....………………………….….....… NDC 58657-730-10 Carton of 50 tablets (10 tablets per blister pack x 5) …………...................
NDC 58657-930-05 Carton of 100 tablets (10 tablets per blister pack x 10)……………............. NDC 58657-930-01 Baclofen Tablets USP, 10 mg – white to off-white, round, flat tablet with bevel edge, debossed “I 114” on one side and scored on the other side. Bottles of 100………....…………………………………………...…….
NDC 58657-731-01 Bottles of 500………………....………………………………...………. NDC 58657-731-50 Bottles of 1000……………………………………………..………...…. NDC 58657-731-10 Carton of 50 tablets (10 tablets per blister pack x 5) ……………...............
NDC 58657-931-05 Carton of 100 tablets (10 tablets per blister pack x 10)……………............. NDC 58657-931-01 Baclofen Tablets USP, 20 mg – white to off-white, round, flat tablet with bevel edge, debossed “I 115” on one side and scored on the other side. Bottles of 100…………………....…………………………………...….
NDC 58657-732-01 Bottles of 500…………………………………………...........…………. NDC 58657-732-50 Bottles of 1000………………………………………...……………...… NDC 58657-732-10 Carton of 50 tablets (10 tablets per blister pack x 5) ……………............... NDC 58657-932-05 Carton of 100 tablets (10 tablets per blister pack x 10)……………….…....
NDC 58657-932-01 PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Distributed by: Method Pharmaceuticals, LLC Southlake, TX 76092 Rev. 06/2025
📋 Description ▾
DESCRIPTION Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is 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 or 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, zinc stearate. baclofen structure
⚠️ Precautions ▾
PRECAUTIONS Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants. Baclofen should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.
In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking baclofen. It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.
A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with baclofen. Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with baclofen for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug.
Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population. Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
📄 Package Label / Principal Display Panel ▾
Baclofen Tablets USP, 5 mg- 100 Tablets Rx Only Baclofen Tablets USP, 5 mg- 1000 Tablets Rx Only Baclofen Tablets USP, 10 mg- 100 Tablets Rx Only Baclofen Tablets USP, 10 mg- 500 Tablets Rx Only Baclofen Tablets USP, 10 mg- 1000 Tablets Rx Only Baclofen Tablets USP, 20 mg- 100 Tablets Rx only Baclofen Tablets USP, 20 mg- 500 Tablets Rx only Baclofen Tablets USP, 20 mg- 1000 Tablets Rx only Baclofen Tablets USP, 5 mg- 50 Tablets Rx Only Baclofen Tablets USP, 5 mg- 100 Tablets Rx Only Baclofen Tablets USP, 10 mg- 50 Tablets Rx Only Baclofen Tablets USP, 10 mg- 100 Tablets Rx Only Baclofen Tablets USP, 20 mg- 50 Tablets Rx Only Baclofen Tablets USP, 20 mg- 100 Tablets Rx Only 5mg 100ct 5mg 1000ct 10mg 100ct 10mg 500ct 10mg 1000ct 20mg 100ct 20mg 500ct 20mg 1000ct bac1 bac2 bac2 bac4 bac5 bac6