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BACLOFEN 20 mg Tablet, 100-count — NDC 00904-7553-61 package photo

BACLOFEN 20 mg Tablet, 100-count

by Major Pharmaceuticals · 10 BLISTER PACK in 1 CARTON (0904-7553-61) / 10 TABLET in 1 BLISTER PACK
NDC 00904-7553-61
🏷️ FDA NDC (as labeled) 0904-7553-61 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Baclofen (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Nov 26, 2025 — Presence of Foreign Tablets/Capsules (Golden State Medical Supply Inc.) · FDA recall D-0235-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0904-7553-61
Product NDC 0904-7553
11-digit billing NDC 00904755361
NCPDP billing unit EA — each (per item)
RxCUI 197391, 197392
UNII H789N3FKE8
Application # ANDA215885
SPL Set ID f328296e-0713-4acb-bcb5-c10d7838d380
Established class (EPC) gamma-Aminobutyric Acid-ergic Agonist
Mechanism of action GABA A Agonists; GABA B Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-01
Route ORAL
Dosage form TABLET
Substance BACLOFEN
GPI-14 75100010000310
GCN Seq No 004680
GCN 18011
HICL code 001949
Ingredient (HICL) Baclofen
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6H
Therapeutic class — specific (HIC3) Skeletal Muscle Relaxants
AHFS code 12:20.12.00
AHFS class Gaba-Derivative Skeletal Muscle Relaxant
FDB label name BACLOFEN 20 MG TABLET
FDB brand name Baclofen
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0904-7553-61 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00904-7553-61. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the gamma-Aminobutyric Acid-ergic Agonist class.

Pharmacologic class gamma-Aminobutyric Acid-ergic Agonist
Drug family (ATC) Other centrally acting agents
How it works GABA B Agonists, GABA A Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMajor Pharmaceuticals
Application holderMANKIND PHARMA LTD
FDA applicationANDA215885 (ANDA)
Labeler code00904
First marketedNov 2025
Product typeHuman Prescription Drug
Portfolio629 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BACLOFEN 20 MG TABLET Ingredient Baclofen
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Baclofen guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeRound
ImprintLS;289
Size11 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • 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 O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.051 $5.09 / 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
NADAC price history (per ea) — tap or hover for the price & month
Feb 2026 Apr 2026 Jun 2026 Aug 2026 $0.056 $0.051
▼ Down 1% over the last 7 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Baclofen 20 mg 00172-4097-60 Teva 100 tablets $0.051 AB Availability likely —
Baclofen 20 mg 00527-1337-01 Lannett 100 tablets $0.051 AB Availability likely —
Baclofen 20 mg 00603-2407-21 Par 100 tablets $0.051 AB Availability likely —
Baclofen 20 mg 00904-6476-61 Major 100 tablets $0.051 AB Availability likely —
Baclofen 20 mgthis 00904-7553-61 Major 100 tablets $0.051 AB Availability likely —
Baclofen 20 mg 16571-0172-01 Rising 100 tablets $0.051 AB Availability likely —
Baclofen 20 mg 16714-0072-04 Northstar 100 tablets $0.051 AB Availability likely —
Baclofen 20 mg 29300-0344-01 Unichem 100 tablets $0.051 AB Availability likely —
Baclofen 20 mg 50268-0107-15 AvPAK 50 tablets $0.051 AB Availability likely —
Baclofen 20 mg 52817-0321-00 TruPharma 1000 tablets $0.051 AB Availability likely —
Baclofen 20 mg 58657-0732-01 Method 100 tablets $0.051 AB Availability likely —
Baclofen 20 mg 58657-0932-01 Method 100 tablets $0.051 AB Availability likely —
Baclofen 20 mg 59651-0395-01 Aurobindo 100 tablets $0.051 AB Availability likely —
Baclofen 20 mg 60687-0826-01 American 100 tablets $0.051 AB Availability likely —
Baclofen 20 mg 62135-0474-05 Chartwell 500 tablets $0.051 AB Availability likely —
Baclofen 20 mg 70710-1286-00 Zydus 1000 tablets $0.051 AB Availability likely —
Baclofen 20 mg 70756-0289-11 Lifestar 100 tablets $0.051 AB Availability likely —
Baclofen 20 mg 71930-0007-12 Eywa 100 tablets $0.051 AB Availability likely —
Baclofen 20 mg 72888-0011-00 Advagen 1000 tablets $0.051 AB Availability likely —
Baclofen 20 mg 00832-1055-10 Upsher-Smith 1000 tablets $0.093 AB FDA listed +83%
Baclofen 20 mg 00615-8467-39 NCS 30 tablets — AB FDA listed —
Baclofen 20 mg 10135-0533-01 Marlex 100 tablets — AB FDA listed —
Baclofen 20 mg 42571-0429-01 Micro 100 tablets — AB Discontinued —
Baclofen 20 mg 43063-0865-30 PD-Rx 30 tablets — AB FDA listed —
Baclofen 20 mg 50090-4682-00 A-S 20 tablets — AB FDA listed —
Baclofen 20 mg 51407-0974-01 Golden 100 tablets — AB FDA listed —
Baclofen 20 mg 55154-7876-00 Cardinal 10 tablets — AB FDA listed —
Baclofen 20 mg 63187-0274-30 Proficient 30 tablets — AB FDA listed —
Baclofen 20 mg 63187-0280-30 Proficient 30 tablets — AB FDA listed —
Baclofen 20 mg 63629-1227-01 Bryant 1000 tablets — AB FDA listed —
Baclofen 20 mg 63629-1228-01 Bryant 100 tablets — AB FDA listed —
Baclofen 20 mg 63629-2083-01 Bryant 500 tablets — AB FDA listed —
Baclofen 20 mg 63629-2084-01 Bryant 100 tablets — AB FDA listed —
Baclofen 20 mg 63629-2130-01 Bryant 1000 tablets — AB FDA listed —
Baclofen 20 mg 63629-2131-01 Bryant 100 tablets — AB FDA listed —
Baclofen 20 mg 68788-8575-03 Preferred 30 tablets — AB FDA listed —
Baclofen 20 mg 68788-8737-01 Preferred 100 tablets — AB FDA listed —
Baclofen 20 mg 70518-3467-00 REMEDYREPACK 30 tablets — AB FDA listed —
Baclofen 20 mg 70518-4235-00 REMEDYREPACK 30 tablets — AB FDA listed —
Baclofen 20 mg 70518-4290-00 REMEDYREPACK 30 tablets — AB FDA listed —
Baclofen 20 mg 70518-4378-00 REMEDYREPACK 90 tablets — AB FDA listed —
Baclofen 20 mg 70518-4530-00 REMEDYREPACK 30 tablets — AB FDA listed —
Baclofen 20 mg 70771-1449-00 Zydus 1000 tablets — AB FDA listed —
Baclofen 20 mg 71335-0103-00 Bryant 120 tablets — AB FDA listed —
Baclofen 20 mg 71335-0949-00 Bryant 120 tablets — AB FDA listed —
Baclofen 20 mg 71335-1356-00 Bryant 120 tablets — AB FDA listed —
Baclofen 20 mg 71335-1796-00 Bryant 120 tablets — AB FDA listed —
Baclofen 20 mg 71335-2219-00 Bryant 120 tablets — AB FDA listed —
Baclofen 20 mg 71335-2482-01 Bryant 60 tablets — AB FDA listed —
Baclofen 20 mg 71335-2497-00 Bryant 120 tablets — AB FDA listed —
Baclofen 20 mg 71335-2668-00 Bryant 120 tablets — AB FDA listed —
Baclofen 20 mg 71335-2669-01 Bryant 100 tablets — AB FDA listed —
Baclofen 20 mg 71335-2756-00 Bryant 120 tablets — AB FDA listed —
Baclofen 20 mg 71335-9681-00 Bryant 120 tablets — AB FDA listed —
Baclofen 20 mg 71610-0444-45 Aphena 45 tablets — AB FDA listed —
Baclofen 20 mg 71610-0446-45 Aphena 45 tablets — AB FDA listed —
Baclofen 20 mg 71610-0921-60 Aphena 90 tablets — AB FDA listed —
Baclofen 20 mg 72162-1080-00 Bryant 120 tablets — AB FDA listed —
Baclofen 20 mg 72162-2374-00 Bryant 1000 tablets — AB FDA listed —
Baclofen 20 mg 72162-2450-00 Bryant 1000 tablets — AB FDA listed —
Baclofen 20 mg 72189-0504-60 Direct_Rx 60 tablets — AB FDA listed —
Baclofen 20 mg 72189-0565-60 Direct_rx 60 tablets — AB FDA listed —
Baclofen 20 mg 72789-0312-30 PD-Rx 30 tablets — AB FDA listed —
Baclofen 20 mg 72789-0480-01 PD-Rx 100 tablets — AB FDA listed —
Baclofen 20 mg 72865-0298-01 XLCare 100 tablets — AB FDA listed —
Baclofen 20 mg 76420-0242-30 Asclemed 30 tablets — AB FDA listed —
Baclofen 20 mg 76420-0359-00 Asclemed 1000 tablets — AB FDA listed —
Baclofen 20 mg 80425-0081-02 Advanced 60 tablets — AB FDA listed —
Baclofen 20 mg 80425-0112-01 Advanced 30 tablets — AB FDA listed —
Baclofen 20 mg 80425-0157-01 Advanced 30 tablets — AB FDA listed —
Baclofen 20 mg 80425-0205-01 Advanced 30 tablets — AB FDA listed —
Baclofen 20 mg 80425-0282-01 Advanced 30 tablets — AB FDA listed —
Baclofen 20 mg 80425-0459-01 Advanced 30 tablets — AB FDA listed —
Baclofen 20 mg 80425-0466-01 Advanced 30 tablets — AB FDA listed —
Baclofen 20 mg 80425-0467-01 Advanced 30 tablets — AB FDA listed —
Baclofen 20 mg 80425-0478-01 Advanced 30 tablets — AB FDA listed —
Baclofen 20 mg 82461-0718-10 Medcore 100 tablets — AB FDA listed —
Baclofen 20 mg 83008-0062-30 Quality 30 tablets — AB FDA listed —
Baclofen 20 mg 85509-1344-03 PHOENIX 30 tablets — AB FDA listed —
Baclofen 20 mg 85534-0004-00 HAWAII 100 tablets — AB FDA listed —
Baclofen 20 mg 70518-3115-00 REMEDYREPACK 90 tablets — AB Discontinued —
Baclofen 20 mg 68788-4162-01 Preferred 100 tablets — AB FDA listed —
Baclofen 20 mg 71335-1664-00 Bryant 120 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Baclofen — the program that covers self-administered drugs. 23 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Baclofen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$22.67M
Claims incl. refills
1.3M
Beneficiaries
744.4K
Spend / beneficiary
$30.45
Spend / claim
$17.31
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Baclofen — the ingredient across all brands.

Top reported reactions

Fatigue6,296
Pain5,852
Fall5,569
Nausea4,756
Headache4,525
Gait Disturbance4,179
Dizziness3,650

Reporter sex

0 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization28,757
Death6,566
Life-threatening2,815
Disabling2,171
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,707 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00904-7553-61 You're viewing this 10 BLISTER PACK in 1 CARTON (0904-7553-61) / 10 TABLET in 1 BLISTER PACK 2025-11-01 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 108 words ▾

INDICATIONS AND USAGE Baclofen tablets 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 may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen tablets 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 120 words ▾

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 4 words ▾

CONTRAINDICATIONS Hypersensitivity to baclofen.

⚠️ Warnings ~1 min read ▾

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 ~1 min read ▾

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 Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧒 Pediatric Use 18 words ▾

Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

🆘 Overdosage 58 words ▾

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 147 words ▾

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 171 words ▾

HOW SUPPLIED Baclofen Tablets USP, 10 mg are available as a white to off white, round, flat-faced, beveled edge tablet, debossed with "LS 288" on one side and functional scored on the other side, containing 10 mg baclofen, USP are supplied as follows: Unit-dose child-resistant blister pack of 100 (10 x 10) tablets NDC 0904-7552-61 Baclofen Tablets USP, 20 mg are available as a white to off white, round, flat-faced, beveled edge tablet debossed with "LS 289" on one side and functional scored on the other side, containing 20 mg baclofen, USP are supplied as follows: Unit-dose child-resistant blister pack of 100 (10 x 10) tablets NDC 0904-7553-61 Dispense in a well-closed container as defined in the USP, with a child-resistant closure.

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: MAJOR• PHARMACEUTICALS Indianapolis, IN 46268 Manufactured by: Mankind Pharma Limited Paonta Sahib, Sinnaur Himachal Pradesh 173025, India.

Revised: February 2025 Code No.: HP/Drugs/N-MNB/17/194

📋 Description 96 words ▾

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 10 mg or 20 mg baclofen, USP.

In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Structural Formula

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.