NDC 17856-0620-04 — Baclofen 10 mg/5mL Solution

🆔 Identity & classification

FDA NDC (as labeled) 17856-0620-4

Product NDC 17856-0620

11-digit billing NDC 17856062004

UNII H789N3FKE8

Application # NDA208193

SPL Set ID 50b3e7be-832b-313d-e063-6394a90a5ab4

Established class (EPC) gamma-Aminobutyric Acid-ergic Agonist

Mechanism of action GABA A Agonists; GABA B Agonists

DEA schedule Non-controlled

Marketing category NDA AUTHORIZED GENERIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2023-10-12

Route ORAL

Dosage form SOLUTION

Substance BACLOFEN

GCN Seq No 085432

GCN 54913

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 10 MG/5 ML SOLN CUP

FDB brand name Baclofen

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AA · RLD · RS

Why two NDCs? The FDA registers this code as 17856-0620-4 — a 5-4-1 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 package segment → 17856-0620-04. 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.

🏭 Manufacturer & labeler

LabelerAtlantic Biologicals Corp.

Application holderMETACEL PHARMACEUTICALS LLC

FDA applicationNDA208193 (NDA AUTHORIZED GENERIC)

Labeler code17856

First marketedOct 2023

Product typeHuman Prescription Drug

Portfolio109 products on file

🔎 All NDCs from Atlantic Biologicals Corp.

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 10 MG/5 ML SOLN CUP Ingredient Baclofen

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Baclofen — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Baclofen (27 interactions) — ranked by severity →

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.

🧪 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 PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 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 system	Per mL	Per 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 · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 2.5 mL 45 syringes 72 cups 72 cups 90 syringes

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Baclofen 10 mg/5mL 52817-0620-08	TRUPHARMA,	237 ml	$2.085	AA	Availability likely	—
Baclofen 10 mg/5mLthis 17856-0620-04	Atlantic	1 syringe	—	AA	FDA listed	—
Baclofen 10 mg/5mL 68134-0403-16	Palmetto	473 ml	—	AA	FDA listed	—
Ozobax Ds 10 mg/5mL 69528-0302-08	Rosemont	237 ml	—	AA	FDA listed	—
Baclofen 10 mg/5mL 72834-0602-16	Rosemont	473 ml	—	AA	Discontinued	—
Baclofen 10 mg/5mL 72888-0466-01	Advagen	473 ml	—	—	FDA listed	—

About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️

2023

First FDA approval

Oct 2023

📍

2026

Currently FDA-listed

3 years listed

🛡️

2039

Latest patent/protection listed

not a guaranteed launch date

✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Oct 12, 2023 AA TE-rated RLD RS ⏳ ~12.9 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book

US 10610502 — method of use (U-2779)

2023 2025 2027 2029 2031 2033 2035 2037 2039

Today

LOE

Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo

🏛️FDA exclusivity

FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.

🧪Product / substance patents

Patents covering the active ingredient, product, formulation, or related drug features.

🎯Method-of-use patents

Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.

🛈 What do these terms mean?

Patent: Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent: Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent: Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent: A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label: A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity: FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV: A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS: Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating: FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity): The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)

Patent	Type	Use code	Expires
US 10610502 ↗	Method of use	U-2779	Aug 30, 2039

Common questions

Is there a generic version of BACLOFEN 10 MG/5 ML SOLN CUP?

Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for BACLOFEN 10 MG/5 ML SOLN CUP. See the alternatives section for substitutable, lower-cost products.

The FDA approved a generic — why can’t I get it at my pharmacy yet?

FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.

Why do different websites show different generic release dates?

Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.

What does “FDA listed” mean?

It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).

What does “current Orange Book estimate” mean?

It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.

Can a generic come out before the last patent expires?

Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.

Can a generic come out after the listed dates?

Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.

What is the difference between patents and exclusivity?

Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.

Why are there multiple patent dates?

One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.

Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.

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

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

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 NDC	Description	Marketing start	Status
17856-0620-01	72 CUP, UNIT-DOSE in 1 CASE (17856-0620-1) / 2.5 mL in 1 CUP, UNIT-DOSE	2026-04-30	Active
17856-0620-02	72 CUP, UNIT-DOSE in 1 CASE (17856-0620-2) / 5 mL in 1 CUP, UNIT-DOSE	2026-04-30	Active
17856-0620-03	1 SYRINGE in 1 BAG (17856-0620-3) / 2.5 mL in 1 SYRINGE	2026-07-14	Active
17856-0620-04 You're viewing this	1 SYRINGE in 1 BAG (17856-0620-4) / 5 mL in 1 SYRINGE	2026-07-14	Active
17856-0620-05	45 SYRINGE in 1 BOX, UNIT-DOSE (17856-0620-5) / 5 mL in 1 SYRINGE	2026-09-04	Active
17856-0620-09	90 SYRINGE in 1 BOX, UNIT-DOSE (17856-0620-9) / 2.5 mL in 1 SYRINGE	2026-09-04	Active

Pack size FAQ

What quantity is in NDC 17856-0620-04?

NDC 17856-0620-04 is listed by the FDA — 1 syringe in 1 bag / 5 ml in 1 syringe.

What NDC number is used to bill for this package of Baclofen 10 mg/5mL Solution?

Bill NDC 17856-0620-04 — the 11-digit billing format is 17856062004. 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)	✓ 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 17856-0620-4, 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: 17856-0620-04, written without dashes as 17856062004. 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 17856-0620-04, the first segment (17856) is the labeler code FDA assigned to Atlantic Biologicals Corp.; the middle segment (0620) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Atlantic Biologicals Corp.. 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 5 other package presentations of this same product, including 1 syringe (17856-0620-03), 45 syringes (17856-0620-05), 72 cups (17856-0620-01). 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?

Atlantic Biologicals Corp. 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 154 words ▾

1 INDICATIONS AND USAGE Baclofen oral solution is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use Baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

Baclofen oral solution is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. ( 1 ) Baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases. ( 1 ) Limitations of Use Baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Baclofen oral solution is available in multiple concentrations; include both the total dose in mg and the total dose in volume on prescriptions ( 2.1 ) Initiate baclofen oral solution with a low dosage, preferably in divided doses, administered orally. Increase gradually based on clinical response and tolerability. ( 2.2 ) The maximum dosage is 80 mg daily (20 mg four times a day).

( 2.2 ) When discontinuing, reduce the dosage slowly. ( 2.3 )

2.1Important Dosage Information Baclofen oral solution is available in multiple concentrations; ensure accuracy when prescribing, dispensing and administering baclofen oral solution to avoid dosing errors due to confusion between mg and mL, and with other baclofen oral solutions of different concentrations. When writing prescriptions, include both the total dose in mg and the total dose in volume.

2.2Recommended Dosage Initiate baclofen oral solution with a low dosage, preferably in divided doses, administered orally. The following gradually increasing dosage regimen is suggested, but should be adjusted based on clinical response and tolerability: 5 mg (2.5 mL) three times a day for three days 10 mg (5 mL) three times a day for three days 15 mg (7.5 mL) three times a day for three days 20 mg (10 mL) three times a day for three days Additional increases may be necessary up to the maximum recommended dosage of 80 mg daily (20 mg four times a day).

2.3Discontinuation of Baclofen Oral Solution When discontinuing baclofen oral solution, reduce the dosage slowly and avoid abrupt withdrawn from the drug to help minimize the risk of adverse reactions [see Warnings and Precautions ( 5.1 )].

💊 Dosage Forms and Strengths 24 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Solution: 10 mg/5 mL baclofen as a clear, colorless solution Oral Solution: 10 mg/5 mL ( 3 )

⛔ Contraindications 19 words ▾

4 CONTRAINDICATIONS Baclofen oral solution is contraindicated in patients with hypersensitivity to baclofen. Hypersensitivity to baclofen ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when baclofen oral solution is discontinued. ( 5.1 ) Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue baclofen oral solution before delivery. ( 5.2 ) Baclofen oral solution can cause drowsiness and sedation.

Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. Advise patients that the central nervous system effects of baclofen oral solution may be additive to those of alcohol and other CNS depressants. ( 5.3 ) Baclofen oral solution can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy.

Use with caution in patients with these conditions ( 5.5 , 5.6 , 5.7 )

5.1Adverse Reactions from Abrupt Withdrawal of Baclofen Oral Solution Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death. Therefore, reduce the dosage slowly when baclofen oral solution is discontinued, unless the clinical situation justifies a rapid withdrawal.

5.2Neonatal Withdrawal Symptoms Withdrawal symptoms in neonates whose mothers were treated with oral baclofen throughout pregnancy have been reported starting hours to days after delivery. 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 baclofen oral solution is continued during pregnancy, gradually reduce the dosage and discontinue baclofen oral solution before delivery.

If slow withdrawal is not feasible, advise the parents or caregivers of the exposed neonate of the potential for neonatal withdrawal.

5.3Drowsiness and Sedation Drowsiness and sedation have been reported in up to 63% of patients taking baclofen, the active ingredient in baclofen oral solution [see Adverse Reactions ( 6.1 )] . Patients should avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting baclofen oral solution or increasing the dose until they know how the drug affects them. Advise patients that the central nervous system depressant effects of baclofen oral solution may be additive to those of alcohol and other CNS depressants.

5.4Poor Tolerability in Stroke Patients Baclofen oral solution should be used with caution in patients who have had a stroke. Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.

5.5Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Baclofen oral solution should be used with caution in patients suffering from psychotic disorders, schizophrenia, or confusional states. If treated with baclofen oral solution, these patients should be kept under careful surveillance because exacerbations of these conditions have been observed with oral baclofen administration.

5.6Exacerbation of Autonomic Dysreflexia Baclofen oral solution should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of baclofen oral solution may cause an autonomic dysreflexic episode.

5.7Exacerbation of Epilepsy Baclofen oral solution should be used with caution in patients with epilepsy. Deterioration in seizure control has been reported in patients taking baclofen.

5.8Posture and Balance Effects Baclofen oral solution should be used with caution in patients where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obta…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Adverse Reactions from Abrupt Withdrawal of Baclofen Oral Solution [see Warnings and Precautions ( 5.1 )] Neonatal Withdrawal Symptoms [see Warnings and Precautions ( 5.2 )] Drowsiness and Sedation [see Warnings and Precautions ( 5.3 )] Poor Tolerability in Stroke Patients [see Warnings and Precautions ( 5.4 )] Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States [see Warnings and Precautions ( 5.5 )] Exacerbation of Autonomic Dysreflexia [see Warnings and Precautions ( 5.6 )] Exacerbation of Epilepsy [see Warnings and Precautions ( 5.7 )] Posture and Balance Effects [see Warnings and Precautions ( 5.8 )] Ovarian Cysts [see Warnings and Precautions ( 5.9 )] The most common (up to 15% or more) adverse reactions in patients were drowsiness, dizziness, and weakness.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact TruPharma, LLC at 1-877-541-5504 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction is transient drowsiness. 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 (up to 15%) are dizziness and weakness. Adverse reactions with a frequency of ≥1% are listed in Table 1. Table 1.

Common (≥1%) Adverse Reactions in Patients Treated with Baclofen for Spasticity ADVERSE REACTION PERCENT Drowsiness 10-63% Dizziness 5-15% Weakness 5-15% Nausea 4-12% Confusion 1-11% Hypotension 0-9% Headache 4-8% Insomnia 2-7% Constipation 2-6% Urinary Frequency 2-6% Fatigue 2-4% The following adverse reactions not included in Table 1, classified by body system, were also reported: Neuropsychiatric: 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: dyspnea, palpitation, chest pain, syncope Gastrointestinal: dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool Genitourinary: enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria Other: rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion The following laboratory tests have been found to be abnormal in patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

🔄 Drug Interactions 38 words ▾

7 DRUG INTERACTIONS

7.1CNS Depressants and Alcohol Baclofen oral solution can cause CNS depression, including drowsiness and sedation, which may be additive when used concomitantly with other CNS depressants or alcohol [see Warnings and Precautions ( 5.3)].

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ) Because baclofen is excreted unchanged through the kidneys it may be necessary to reduce the dosage in patients with impaired renal function. ( 8.6 )

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of baclofen oral solution in pregnant women. Oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose which was also associated with maternal toxicity. The background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal adverse reactions Baclofen oral solution may increase the risk of late-onset neonatal withdrawal symptoms [see Warnings and Precautions ( 5.2 )] . Data Animal Data Baclofen given orally has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times on a mg/kg basis, or 3 times on a mg/m 2 basis, the maximum oral dose recommended for human use; this dose also caused reductions in food intake and weight gain in the dams.

This abnormality was not seen in mice or rabbits.

8.2Lactation Risk Summary At recommended oral doses, baclofen is present in human milk. There are no human data on the effects of baclofen on milk production. There are no adequate data on the effects of baclofen on the breastfed infant.

Withdrawal symptoms can occur in breastfed infants when maternal administration of baclofen oral solution is stopped, or when breastfeeding is stopped [see Warnings and Precautions ( 5.2 )] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for baclofen oral solution and any potential adverse effects on the breastfed infant from baclofen oral solution or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established.

8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6Renal Impairment Because baclofen is primarily excreted unchanged through the kidneys, baclofen oral solution should be given with caution to patients with renal impairment, and it may be necessary to reduce the dosage.

🆘 Overdosage 49 words ▾

10 OVERDOSAGE

10.1Symptoms of Baclofen Overdose Patients may present in coma or with progressive drowsiness, lightheadedness, dizziness, somnolence, accommodation disorders, respiratory depression, seizures, or hypotonia progressing to loss of consciousness.

10.2Treatment for Overdose The treatment of baclofen overdose includes gastric decontamination, maintaining an adequate airway and respirations.

🧬 Clinical Pharmacology 197 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism of action of baclofen is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Baclofen is a structural analog of the inhibitory neurotransmitter gamma- aminobutyric acid (GABA), and may exert its effects by stimulation of the GABA B receptor subtype.

12.2Pharmacodynamics 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 [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 ), and Overdosage ( 10.1 )].

12.3Pharmacokinetics A pharmacokinetic study in heathy adult male subjects under fasting conditions at 20 mg dose level demonstrated similar bioavailability for baclofen oral solution (5 mg/5 mL) and oral tablets. The peak plasma concentrations were achieved in about 0.75 hours from oral solution and the apparent elimination half-life is about 5.7 hours. 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 93 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Baclofen Oral Solution contains 10 mg/5 mL baclofen. It is a clear, colorless solution. UD Cups - 17856-0620-01 -

2.5 ML 72 ct 17856-0620-02 - 5 ML 72 ct UD Syringes - 17856-0620-03

2.5 ML Enfit 1 ct 17856-0620-09

2.5ML Enfit 90 ct 17856-0620-04 5 ML Enfit 1 ct 17856-0620-05 5 mL Enfit 45 ct Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

📋 Description 100 words ▾

11 DESCRIPTION Baclofen oral solution is a gamma-aminobutyric acid (GABA-ergic) agonist available as 10 mg/5 mL solution for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is: Molecular formula is C 1O H 12 CINO 2 . Molecular Weight is 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. The baclofen oral solution inactive ingredients are: glycerin, methylparaben, propylparaben, purified water, and sucralose.

May also contain sodium hydroxide or hydrochloric acid for pH adjustment. bac structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Administration Instructions Instruct patients or caregivers to use an oral dosing syringe to correctly measure the prescribed amount of medication. Inform patients that oral dosing syringes may be obtained from their pharmacy. Risks Related to Sudden Withdrawal of Baclofen Oral Solution Advise patients and caregivers not to discontinue use of baclofen oral solution without consulting with their healthcare provider because sudden withdrawal of baclofen oral solution can result in serious complications that include hallucinations, seizures, high fever, confusion, muscle stiffness, multiple organ-system failure, and death [see Warnings and Precautions ( 5.1 )].

Inform patients that early symptoms of baclofen oral solution withdrawal may include increased spasticity, itching, and tingling of extremities. Neonatal Withdrawal Symptoms Advise patients to notify their healthcare provider if they are pregnant, plan to become pregnant, or plan to breastfeed [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.2 )]. Increased Risk of Drowsiness with Alcohol and Other CNS Depressants Advise patients that baclofen oral solution may cause drowsiness, and that they should avoid the operation of automobiles or other dangerous machinery, or activities made hazardous by decreased alertness when starting baclofen oral solution or increasing the dose until they know how the drug affects them [see Warnings and Precautions ( 5.3 )].

Inform patients and their caregivers that the drowsiness associated with baclofen oral solution use can be worsened by alcohol and other CNS depressants. Advise patients to read all medicine labels carefully, and to tell their healthcare provider about all prescription and nonprescription drugs they may use. Distributed by: Atlantic Biologicals Corp.

Miami, FL 33179

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

CNS depression: A slowing of brain and nervous-system activity that can cause drowsiness, slowed breathing, or reduced alertness.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

diplopia: Double vision, or seeing two images of a single object.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysarthria: Slurred or slow speech caused by weakness or poor control of the muscles used for speaking.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

dystonia: Involuntary muscle contractions that cause twisting movements or abnormal, sometimes painful, body postures.

dysuria: Pain, burning, or discomfort when passing urine.

edema: Swelling caused by extra fluid trapped in the body's tissues.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

euphoria: An intense feeling of happiness or well-being that is stronger than a normal good mood.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hematuria: Blood in the urine.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

mydriasis: Widening of the pupil, the dark center of the eye.

neonatal: Relating to a newborn baby during its first four weeks of life.

nystagmus: Rapid, involuntary back-and-forth movements of the eyes that a person cannot control.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

pruritus: Itching of the skin.

rebound: The return of symptoms, sometimes worse than before, after a medicine that was controlling them is stopped.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

rhabdomyolysis: A serious condition where damaged muscle breaks down and releases material into the blood that can harm the kidneys.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

urinary retention: Being unable to empty the bladder fully or at all.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Baclofen NDCsSame ingredient 🏭 All Atlantic labeler NDCsLabeler code 17856 📚 All gamma-Aminobutyric Acid-ergic Agonist NDCsDrug class 📖 Read the Baclofen drug informationUses, warnings & side effects

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