Baclofen 5 mg Tablet, 50-count — NDC 60687-804-65 (Billing 60687-0804-65)
This is a package of 50 tablets of Baclofen 5 mg Tablet from American Health Packaging, marketed since May 2024 and currently FDA-listed; retail pharmacies pay about $0.0680 per tablet (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 60687-804-65 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 60687 labeler · 804 product · 65 package
- Package marketed since
- May 26, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 50 EA per package
- Barcode (UPC-A, from the NDC)
- 3 6068780465 1
- FDA record last changed
- Jul 24, 2026
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
- 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 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
- 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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 | $3.40 / 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?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 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 | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 60687-0804-65 You're viewing this Main listing | 50 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK | 2024-05-26 | — | Active |
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 | — | — | 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 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 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 Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 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.
🧪 Avoiding an ingredient? See Baclofen inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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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.
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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.
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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 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.
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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.
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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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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
More NDCs from American Health Packaging labeler code 60687
- Amantadine Hydrochloride 50 mg/5mL Solution NDC 60687-797-56
- Amoxicillin 500 mg Tablet, Film Coated NDC 60687-798-25
- Haloperidol 2 mg/mL Solution NDC 60687-799-17
- Nystatin 100000 [USP'U]/mL Suspension NDC 60687-800-17
- Buspirone hydrochloride 7.5 mg Tablet NDC 60687-801-21
- Amoxicillin and Clavulanate Potassium 875 mg; 125 mg Tablet, Film Coated NDC 60687-803-01
- Lithium Carbonate 300 mg Capsule NDC 60687-806-01
- Chlordiazepoxide Hydrochloride 25 mg Capsule NDC 60687-807-01
- Darunavir 600 mg Tablet NDC 60687-808-21
- Amoxicillin 875 mg Tablet, Film Coated NDC 60687-809-28
- Potassium Chloride 750 mg Tablet, Film Coated, Extended Release NDC 60687-810-09
- Hydralazine Hydrochloride 10 mg Tablet NDC 60687-811-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 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 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
⚠️ 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 ▾
Package/Label Display Panel – Carton – 5 mg NDC 60687- 804 -65 Baclofen Tablets, USP 5 mg 50 Tablets (5 x 10) Rx Only Each Tablet Contains: Baclofen USP.............................................................................. 5 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 70710-1609, Zydus Pharmaceuticals (USA) Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 780465 0480465/1223 5 mg Baclofen Tablets Carton
Package/Label Display Panel – Blister – 5 mg Baclofen Tablet, USP 5 mg 5 mg Baclofen Tablet Blister
Package/Label Display Panel - Carton - 10 mg NDC 60687- 815 -65 Baclofen Tablets, USP 10 mg 50 Tablets (5 x 10) Rx Only Each Tablet Contains: Baclofen USP............................................................................10 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
The drug product contained in this package is from NDC # 70710-1285, Zydus Pharmaceuticals (USA) Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 781565 0481565/0525 10 mg Baclofen Tablets Carton 50UD
Package/Label Display Panel – Carton – 10 mg NDC 60687- 815 -01 Baclofen Tablets, USP 10 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Baclofen USP............................................................................10 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
The drug product contained in this package is from NDC # 70710-1285, Zydus Pharmaceuticals (USA) Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 781501 0481501/1223 10 mg Baclofen Tablets Carton
Package/Label Display Panel – Blister – 10 mg Baclofen Tablet, USP 10 mg 10 mg Baclofen Tablet Blister
Package/Label Display Panel – Carton – 20 mg NDC 60687- 826 -01 Baclofen Tablets, USP 20 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Baclofen USP............................................................................ 20 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 70710-1286, Zydus Pharmaceuticals (USA) Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 782601 0482601/1223 20 mg Baclofen Tablets Carton
Package/Label Display Panel – Blister – 20 mg Baclofen Tablet, USP 20 mg 20 mg Baclofen Tablet Blister