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BACLOFEN 10 mg Tablet, 90-count — NDC 76420-0241-90 package photo

BACLOFEN 10 mg Tablet, 90-count

by Asclemed USA, Inc. · 90 TABLET in 1 BOTTLE (76420-241-90)
NDC 76420-0241-90
🏷️ FDA NDC (as labeled) 76420-241-90 billing pads the product segment with a zero
This package
Contains90-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1147/unit — full pricing hub ↓
Also comes in: 30 tablets 76420-0241-30 60 tablets 76420-0241-60 120 tablets 76420-0241-12
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) 76420-241-90
Product NDC 76420-241
11-digit billing NDC 76420024190
NCPDP billing unit EA — each (per item)
RxCUI 197391, 197392
UNII H789N3FKE8
Application # ANDA214099
SPL Set ID 687f48da-bc41-4700-9513-77a32fc86c93
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 2021-07-13
Route ORAL
Dosage form TABLET
Substance BACLOFEN
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 76420-241-90 — a 5-3-2 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 product segment → 76420-0241-90. 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

LabelerAsclemed USA, Inc.
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA214099 (ANDA)
Labeler code76420
First marketedJul 2021
Product typeHuman Prescription Drug
Portfolio652 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

📗 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
ImprintB;20
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 $10.32 / 90 tablets
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 10 mg 00172-4096-60 Teva 100 tablets $0.031 AB Availability likely —
Baclofen 10 mg 00527-1330-01 Lannett 100 tablets $0.031 — Availability likely —
Baclofen 10 mg 00603-2406-21 Par 100 tablets $0.031 AB Availability likely —
Baclofen 10 mg 00832-1054-10 Upsher-Smith 1000 tablets $0.031 AB Availability likely —
Baclofen 10 mg 00904-6475-61 Major 100 tablets $0.031 — Availability likely —
Baclofen 10 mg 00904-7552-61 Major 100 tablets $0.031 AB Availability likely —
Baclofen 10 mg 16571-0171-01 Rising 100 tablets $0.031 AB Availability likely —
Baclofen 10 mg 16714-0071-04 Northstar 100 tablets $0.031 AB Availability likely —
Baclofen 10 mg 29300-0343-01 Unichem 100 tablets $0.031 AB Availability likely —
Baclofen 10 mg 50268-0106-15 AvPAK 50 tablets $0.031 AB Availability likely —
Baclofen 10 mg 52817-0320-00 TruPharma 1000 tablets $0.031 AB Availability likely —
Baclofen 10 mg 58657-0731-01 Method 100 tablets $0.031 AB Availability likely —
Baclofen 10 mg 58657-0931-01 Method 100 tablets $0.031 AB Availability likely —
Baclofen 10 mg 59651-0394-01 Aurobindo 100 tablets $0.031 AB Availability likely —
Baclofen 10 mg 60687-0815-01 American 100 tablets $0.031 AB Availability likely —
Baclofen 10 mg 62135-0473-05 Chartwell 500 tablets $0.031 AB Availability likely —
Baclofen 10 mg 70512-0782-10 SOLA 100 tablets $0.031 AB Availability likely —
Baclofen 10 mg 70710-1285-00 Zydus 1000 tablets $0.031 AB Availability likely —
Baclofen 10 mg 70756-0288-11 Lifestar 100 tablets $0.031 AB Availability likely —
Baclofen 10 mg 71930-0006-12 Eywa 100 tablets $0.031 AB Availability likely —
Baclofen 10 mg 72888-0010-00 Advagen 1000 tablets $0.031 AB Availability likely —
Baclofen 10 mg 00615-8466-05 NCS 15 tablets — AB FDA listed —
Baclofen 10 mg 10135-0532-01 Marlex 100 tablets — AB FDA listed —
Baclofen 10 mg 42571-0428-01 Micro 100 tablets — AB Discontinued —
Baclofen 10 mg 43063-0864-30 PD-Rx 30 tablets — — FDA listed —
Baclofen 10 mg 50090-6149-00 A-S 60 tablets — AB FDA listed —
Baclofen 10 mg 50090-6868-00 A-S 60 tablets — AB FDA listed —
Baclofen 10 mg 50090-6869-00 A-S 90 tablets — AB FDA listed —
Baclofen 10 mg 50090-7600-00 A-S 60 tablets — AB FDA listed —
Baclofen 10 mg 50090-7601-00 A-S 90 tablets — AB FDA listed —
Baclofen 10 mg 50090-7913-00 A-S 90 tablets — AB FDA listed —
Baclofen 10 mg 50090-7928-00 A-S 90 tablets — AB FDA listed —
Baclofen 10 mg 51407-0973-01 Golden 100 tablets — AB FDA listed —
Baclofen 10 mg 55154-0198-00 Cardinal 10 tablets — AB FDA listed —
Baclofen 10 mg 55154-7635-00 Cardinal 10 tablets — — FDA listed —
Baclofen 10 mg 55289-0757-30 PD-Rx 30 tablets — AB FDA listed —
Baclofen 10 mg 63187-0147-30 Proficient 30 tablets — AB FDA listed —
Baclofen 10 mg 63187-0313-20 Proficient 20 tablets — AB FDA listed —
Baclofen 10 mg 63629-1224-01 Bryant 1000 tablets — AB FDA listed —
Baclofen 10 mg 63629-1225-01 Bryant 100 tablets — AB FDA listed —
Baclofen 10 mg 63629-2080-01 Bryant 1000 tablets — — FDA listed —
Baclofen 10 mg 63629-2081-01 Bryant 1000 tablets — — FDA listed —
Baclofen 10 mg 63629-2082-01 Bryant 100 tablets — — FDA listed —
Baclofen 10 mg 63629-2128-01 Bryant 100 tablets — AB FDA listed —
Baclofen 10 mg 67046-1072-03 Coupler 30 tablets — AB FDA listed —
Baclofen 10 mg 67296-1947-03 Redpharm 30 tablets — AB FDA listed —
Baclofen 10 mg 67296-2259-03 Redpharm 30 tablets — AB FDA listed —
Baclofen 10 mg 67544-0671-60 Aphena 90 tablets — — FDA listed —
Baclofen 10 mg 68071-2289-03 NuCare 3 tablets — AB FDA listed —
Baclofen 10 mg 68071-3407-03 NuCare 3 tablets — AB FDA listed —
Baclofen 10 mg 68071-3468-06 NuCare 60 tablets — AB Discontinued —
Baclofen 10 mg 68071-3700-03 NuCare 30 tablets — AB FDA listed —
Baclofen 10 mg 68788-8584-01 Preferred 100 tablets — AB FDA listed —
Baclofen 10 mg 68788-8726-01 Preferred 100 tablets — AB FDA listed —
Baclofen 10 mg 68788-8783-01 Preferred 100 tablets — AB FDA listed —
Baclofen 10 mg 68788-9246-01 Preferred 100 tablets — — FDA listed —
Baclofen 10 mg 70518-3089-00 REMEDYREPACK 30 tablets — AB FDA listed —
Baclofen 10 mg 70518-3614-00 REMEDYREPACK 30 tablets — AB Discontinued —
Baclofen 10 mg 70518-4249-00 REMEDYREPACK 30 tablets — AB FDA listed —
Baclofen 10 mg 70518-4384-00 REMEDYREPACK 90 tablets — AB FDA listed —
Baclofen 10 mg 70771-1448-00 Zydus 1000 tablets — AB FDA listed —
Baclofen 10 mg 71205-0474-14 Proficient 14 tablets — — FDA listed —
Baclofen 10 mg 71335-0344-00 Bryant 112 tablets — — Discontinued —
Baclofen 10 mg 71335-1797-00 Bryant 112 tablets — AB FDA listed —
Baclofen 10 mg 71335-2392-00 Bryant 112 tablets — AB FDA listed —
Baclofen 10 mg 71335-2767-00 Bryant 112 tablets — AB FDA listed —
Baclofen 10 mg 71335-2826-01 Bryant 100 tablets — AB FDA listed —
Baclofen 10 mg 71335-9638-00 Bryant 112 tablets — AB FDA listed —
Baclofen 10 mg 71335-9759-00 Bryant 112 tablets — AB FDA listed —
Baclofen 10 mg 71610-0452-60 Aphena 90 tablets — — FDA listed —
Baclofen 10 mg 71610-0660-60 Aphena 90 tablets — AB FDA listed —
Baclofen 10 mg 71610-0924-53 Aphena 60 tablets — AB FDA listed —
Baclofen 10 mg 72162-1079-08 Bryant 140 tablets — — FDA listed —
Baclofen 10 mg 72162-1152-01 Bryant 100 tablets — — FDA listed —
Baclofen 10 mg 72162-2373-00 Bryant 1000 tablets — AB FDA listed —
Baclofen 10 mg 72162-2449-00 Bryant 1000 tablets — AB FDA listed —
Baclofen 10 mg 72789-0479-01 PD-Rx 100 tablets — AB FDA listed —
Baclofen 10 mg 72789-0508-30 PD-Rx 30 tablets — AB FDA listed —
Baclofen 10 mg 72865-0297-01 XLCare 100 tablets — AB FDA listed —
Baclofen 10 mgthis 76420-0241-90 Asclemed 90 tablets — AB FDA listed —
Baclofen 10 mg 76420-0357-00 Asclemed 1000 tablets — AB FDA listed —
Baclofen 10 mg 80425-0080-02 Advanced 60 tablets — AB FDA listed —
Baclofen 10 mg 80425-0156-01 Advanced 30 tablets — AB FDA listed —
Baclofen 10 mg 80425-0391-01 Advanced 30 tablets — AB FDA listed —
Baclofen 10 mg 80425-0568-01 Advanced 30 tablets — AB FDA listed —
Baclofen 10 mg 82461-0717-10 Medcore 100 tablets — AB FDA listed —
Baclofen 10 mg 82804-0242-20 Proficient 20 tablets — AB FDA listed —
Baclofen 10 mg 82868-0013-30 Northwind 30 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

🏛️
2021
On the market since
Jul 2021
📍
2026
Currently FDA-listed
5 years 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
76420-0241-30 30 TABLET in 1 BOTTLE (76420-241-30) 2022-07-25 Active
76420-0241-60 60 TABLET in 1 BOTTLE (76420-241-60) 2022-07-25 Active
76420-0241-90 You're viewing this 90 TABLET in 1 BOTTLE (76420-241-90) 2022-07-25 Active
76420-0241-12 120 TABLET in 1 BOTTLE (76420-241-12) 2025-01-15 Active

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 76420-0241-90?
NDC 76420-0241-90 is a 90-count package — 90 tablet in 1 bottle.
What is the difference between NDC 76420-0241-90 and NDC 76420-0241-30?
Both are BACLOFEN 10 mg Tablet — the drug itself is identical. NDC 76420-0241-90 is the 90-count package, while NDC 76420-0241-30 is the 30 tablets package.
What NDC number is used to bill for this package of BACLOFEN 10 mg Tablet?
Bill NDC 76420-0241-90 — the 11-digit billing format is 76420024190. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 76420-241-90, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 76420-0241-90, written without dashes as 76420024190. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 76420-0241-90, the first segment (76420) is the labeler code FDA assigned to Asclemed USA, Inc.; the middle segment (0241) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Asclemed USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 30 tablets (76420-0241-30), 60 tablets (76420-0241-60), 120 tablets (76420-0241-12). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Asclemed USA, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 109 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 tablets 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 215 words ▾

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.

🧒 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 186 words ▾

HOW SUPPLIED Baclofen Tablets USP, 10 mg are white to off-white, round, flat-faced, beveled-edge scored tablet debossed with “B” above score line and “10” below score line on one side and plain on other side. They are supplied as follows: Bottles of 30 NDC 76420-241-30 (repackaged from NDC 59651-394-XX) Bottles of 60 NDC 76420-241-60 (repackaged from NDC 59651-394-XX) Bottles of 90 NDC 76420-241-90 (repackaged from NDC 59651-394-XX) Bottles of 120 NDC 76420-241-12 (repackaged from NDC 59651-394-XX) Baclofen Tablets USP, 20 mg are white to off-white, round, flat-faced, beveled-edge scored tablet debossed with “B” above score line and “20” below score line on one side and plain on other side.

They are supplied as follows: Bottles of 30 NDC 76420-242-30 (repackaged from NDC 59651-395-XX) Bottles of 60 NDC 76420-242-60 (repackaged from NDC 59651-395-XX) Bottles of 90 NDC 76420-242-90 (repackaged from NDC 59651-395-XX) Bottles of 120 NDC 76420-242-12 (repackaged from NDC 59651-395-XX) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501

📋 Description 104 words ▾

DESCRIPTION Baclofen USP, is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and in 96% ethanol, practically insoluble in acetone, insoluble in chloroform, dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides.

Inactive Ingredients. Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). FDA approved dissolution test specifications differ from USP.

Chemical Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76420-0240-01 · Asclemed 76420-0242-30 · Asclemed →
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.