NDC 64896-0076-09 — LYVISPAH baclofen 5 mg Granule, 90-count

🆔 Identity & classification

FDA NDC (as labeled) 64896-076-09

Product NDC 64896-076

11-digit billing NDC 64896007609

NCPDP billing unit EA — each (per item)

RxCUI 2586589, 2586595, 2586596, 2586598, 2586599, 2586601

UNII H789N3FKE8

UPC 0364896077097, 0364896078094, 0364896076090

Application # NDA215422

SPL Set ID f8992a56-9010-4c4b-84d5-ddcc3e2c3317

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

Mechanism of action GABA A Agonists; GABA B Agonists

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2023-06-01

Route ORAL

Dosage form GRANULE

Substance BACLOFEN

GCN Seq No 082876

GCN 51638

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 LYVISPAH 5 MG GRANULE PACKET

FDB brand name Lyvispah

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 64896-076-09 — 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 → 64896-0076-09. 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

LabelerAmneal Pharmaceuticals LLC

Application holderSTRIDES PHARMA INTERNATIONAL AG

FDA applicationNDA215422 (NDA)

Labeler code64896

First marketedJun 2023

Product typeHuman Prescription Drug

Portfolio472 products on file

🔎 All NDCs from Amneal Pharmaceuticals LLC

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 LYVISPAH 5 MG GRANULE PACKET 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 →

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.

💊 What it looks like

Color white

ShapeFreeform

FlavorStrawberry

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 776XM7047L
Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
UNII 905HNO1SIH
A synthetic polymer made from methacrylate compounds that forms a film coating on tablets or capsules. It helps control how quickly the medicine dissolves and releases its active ingredient in the digestive system.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
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 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
UNII VCQ006KQ1E
Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

9 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 g	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$3.67	—
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

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
Lyvispah 5 mgthis 64896-0076-09	Amneal	90 granules	—	—	FDA listed	—

About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.

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

First FDA approval

Nov 2021

📍

2026

Currently FDA-listed

5 years listed

🛡️

2041

Latest patent/protection listed

not a guaranteed launch date

🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Nov 22, 2021 RLD RS ⏳ ~15 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 11850225 — method of use (U-3488)

US 11850225 — method of use (U-3489)

US 11850225 — method of use (U-3488)

US 10792262 — method of use (U-3263)

US 11491125 — method of use (U-3488)

US 11491125 — method of use (U-3489)

US 11491125 — method of use (U-3488)

US 11654124 — drug product

US 11931328 — drug product

US 11654124 — drug product

2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041

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 (21)

Patent	Type	Use code	Expires
US 11850225 ↗	Method of use	U-3488	Sep 29, 2041
US 11850225 ↗	Method of use	U-3489	Sep 29, 2041
US 11850225 ↗	Method of use	U-3489	Sep 29, 2041
US 11850225 ↗	Method of use	U-3489	Sep 29, 2041
US 11850225 ↗	Method of use	U-3488	Sep 29, 2041
US 11850225 ↗	Method of use	U-3488	Sep 29, 2041
US 10792262 ↗	Method of use	U-3263	Jul 29, 2039
US 10792262 ↗	Method of use	U-3263	Jul 29, 2039
US 10792262 ↗	Method of use	U-3263	Jul 29, 2039
US 11491125 ↗	Method of use	U-3488	Sep 29, 2041
US 11491125 ↗	Method of use	U-3489	Sep 29, 2041
US 11491125 ↗	Method of use	U-3489	Sep 29, 2041
US 11491125 ↗	Method of use	U-3489	Sep 29, 2041
US 11491125 ↗	Method of use	U-3488	Sep 29, 2041
US 11491125 ↗	Method of use	U-3488	Sep 29, 2041
US 11654124 ↗	Drug product	—	Jul 29, 2039
US 11654124 ↗	Drug product	—	Jul 29, 2039
US 11931328 ↗	Drug product	—	Jul 29, 2039
US 11931328 ↗	Drug product	—	Jul 29, 2039
US 11931328 ↗	Drug product	—	Jul 29, 2039
US 11654124 ↗	Drug product	—	Jul 29, 2039

Common questions

Is there a generic version of LYVISPAH 5 MG GRANULE PACKET?

No FDA-approved generic equivalent is currently listed in the FDA Orange Book for LYVISPAH 5 MG GRANULE PACKET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Sep 2041 — an estimate, not a guaranteed launch date.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 64896-0076-09, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

165

Units reimbursed last 4 qtrs

16.1K

Gross reimbursed last 4 qtrs

$59K

Avg / prescription

$357.36

Avg / unit

$3.6663

Latest quarter Q4 2025

0Rx

Fee-for-service vs managed care ⓘ

100% FFS

Fee-for-service · 165 Rx Managed care · 0 Rx

State Medicaid map

Units reimbursed · per 100k residents

9.9124

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Missouri 124 /100k

2 California 16.6 /100k

3 New York 9.9 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Lyvispah — the program that covers self-administered drugs. 1 manufacturer.

⚠️ 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 Lyvispah. 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.

Total Part D spend

$89.3K

Claims incl. refills

526

Beneficiaries

219

Spend / beneficiary

$407.67

Spend / claim

$169.73

💵 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 LYVISPAH (this brand).

Top reported reactions

Fatigue6,237

Pain5,504

Fall5,413

Nausea4,645

Headache4,402

Gait Disturbance4,112

Dizziness3,602

Reporter sex

Serious outcomes

Hospitalization27,646

Death6,308

Life-threatening2,705

Disabling2,135

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
64896-0076-09 You're viewing this	90 PACKET in 1 CARTON (64896-076-09) / 1 GRANULE in 1 PACKET	2023-06-01	Active

🧭 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)	✓ Available

“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 64896-076-09, 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: 64896-0076-09, written without dashes as 64896007609. 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 64896-0076-09, the first segment (64896) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (0076) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) 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 Amneal Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Amneal Pharmaceuticals LLC 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 142 words ▾

1 INDICATIONS AND USAGE LYVISPAH 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. LYVISPAH may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use LYVISPAH is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

LYVISPAH 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 ) LYVISPAH may also be of some value in patient with spinal cord injuries and other spinal cord diseases. ( 1 ) Limitations of Use LYVISPAH is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Initiate LYVISPAH with a low dosage, preferably in divided doses, administered orally. Increase gradually based on clinical response and tolerability. ( 2.1 ) The maximum dosage is 80 mg daily (20 mg four times a day).

( 2.1 ) LYVISPAH can be taken with or without water. ( 2.2 ) LYVISPAH oral granules can be mixed with soft food for administration within 2 hours. ( 2.2 ) LYVISPAH oral granules can be administered via enteral feeding tubes.

( 2.2 ) When discontinuing, reduce the dose slowly. ( 2.2 )

2.1Recommended Dosage Initiate LYVISPAH 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 three times a day for three days 10 mg three times a day for three days 15 mg three times a day for three days 20 mg 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). Multiple packets or multiple strengths can be used to achieve the prescribed dosage.

2.2Administration Instructions The entire contents of the packet should be emptied into the mouth. The granules will dissolve in the mouth or can be swallowed. LYVISPAH can be taken with liquids or soft foods if needed .

Administration with Liquids or Soft Foods LYVISPAH can be administered orally as a mixture with liquids or soft foods, such as apple sauce, yogurt, or pudding. The contents of one packet can be emptied and mixed with up to 15 mL of liquid or soft food. The mixture should be administered no more than 2 hours after mixing.

If multiple packets are to be administered, each packet must be mixed with a separate volume of liquid or soft food. Administration via Feeding Tube LYVISPAH can also be administered via enteral feeding tubes such as nasogastric (NG) at sizes 8 FR or higher, gastrostomy (G) at sizes 12 FR or higher, percutaneous endoscopic gastrostomy (PEG) at sizes 14 FR or higher, and gastrojejunostomy (GJ) tubes at sizes 16 FR or higher. Flush the feeding tube with up to 15 mL of water using a catheter tip syringe.

Open and empty the full contents of one packet of LYVISPAH in 15 mL of liquid, such as apple juice or milk, in a clean container. Mix the suspension to ensure all granules are wetted. Draw up the suspension of granules into a dosing syringe immediately after mixing and administer the dose via the feeding tube.

Administration should be no longer than two hours after mixing. If the syringe is allowed to stand for 15 minutes before administration, invert the syringe three times. Refill the dosing syringe with 15 mL of water and flush the feeding tube.

If multiple packets are to be administered, each packet must be mixed with a separate volume of liquid.

2.3Discontinuation of LYVISPAH When discontinuing LYVISPAH, reduce the dosage slowly and avoid abrupt withdrawal from the drug to help minimize the risk of adverse reactions [see Warnings and Precautions (5.1) ] .

💊 Dosage Forms and Strengths 43 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Granules: 5 mg, 10 mg, or 20 mg baclofen as white to off-white, strawberry flavored granules in a single dose packet. Oral granules: 5 mg, 10 mg, or 20 mg baclofen in a packet ( 3 )

⛔ Contraindications 17 words ▾

4 CONTRAINDICATIONS LYVISPAH 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 LYVISPAH is discontinued. ( 5.1 ) Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue LYVISPAH before delivery. ( 5.2 ) LYVISPAH 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 LYVISPAH may be additive to those of alcohol and other CNS depressants. ( 5.3 ) LYVISPAH 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 LYVISPAH 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 LYVISPAH 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 LYVISPAH is continued during pregnancy, gradually reduce the dosage, and discontinue LYVISPAH 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 LYVISPAH [see Adverse Reactions (6.1) ]. Patients should avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting LYVISPAH or increasing the dosage until they know how the drug affects them. Advise patients that the central nervous system depressant effects of LYVISPAH may be an additive to those of alcohol and other CNS depressants.

5.4Poor Tolerability in Stroke Patients LYVISPAH 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 LYVISPAH should be used with caution in patients suffering from psychotic disorders, schizophrenia, or confusional states. If treated with LYVISPAH, 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 LYVISPAH should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of LYVISPAH may cause an autonomic dysreflexic episode.

5.7Exacerbation of Epilepsy LYVISPAH 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 LYVISPAH 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 obtain increased function.

5.9Ovarian Cysts A dose-related increase in incidence of ovarian cysts was observed in female rats treated chronically with oral baclofen. Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients who were…

🤒 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 LYVISPAH [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 adverse reactions (up to 15% or more) in patients were drowsiness, dizziness, and weakness.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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 37 words ▾

7 DRUG INTERACTIONS

7.1CNS Depressants and Alcohol LYVISPAH can cause CNS depression, including drowsiness and sedation, which may be an 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 risk of major birth defects, miscarriages, or other maternal adverse outcomes associated with the use of LYVISPAH in pregnant women. There are adverse effects on fetal outcomes associated with withdrawal from baclofen after delivery (see Clinical Considerations) . 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 LYVISPAH 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/m² 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 effects of baclofen on milk production. Withdrawal symptoms can occur in breastfed infants when maternal administration of LYVISPAH is stopped, or when breastfeeding is stopped [see Warnings and Precautions (5.2) ] .

There are no adequate data on other effects of baclofen on the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LYVISPAH and any potential adverse effects on the breastfed infant from LYVISPAH 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. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Use in Specific Populations (8.6) ] .

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

🤰 Pregnancy 202 words ▾

8.1Pregnancy Risk Summary There are no adequate data on the risk of major birth defects, miscarriages, or other maternal adverse outcomes associated with the use of LYVISPAH in pregnant women. There are adverse effects on fetal outcomes associated with withdrawal from baclofen after delivery (see Clinical Considerations) . 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 LYVISPAH 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/m² 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.

🧒 Pediatric Use 18 words ▾

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

🧓 Geriatric Use 107 words ▾

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. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Use in Specific Populations (8.6) ] .

🆘 Overdosage 53 words ▾

10 OVERDOSAGE

10.1Symptoms of Baclofen Overdose With overdose of baclofen, 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 ~1 min read ▾

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 Pharmacokinetic studies in heathy adult subjects under fasting conditions at 20 mg dose level demonstrated similar bioavailability for baclofen oral granules and oral tablets. Absorption The peak plasma concentrations of baclofen oral granule formulation were achieved in about one hour and the apparent elimination half-life is about 5.5 hours. The exposure of baclofen was dose proportional across the dose range of 5 mg, 10 mg, and 20 mg.

Effect of Food Administering LYVISPAH with or without water, or with applesauce did not affect the bioavailability of baclofen oral granules. Administration with a high fat meal resulted in 10% decrease in AUC and 29% decrease in Cmax compared to the fasted state. Elimination Baclofen is excreted primarily by the kidney in unchanged form, and there is relatively large intersubject variation in absorption and/or elimination.

🧬 Mechanism of Action 74 words ▾

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 .

📦 How Supplied / Storage and Handling 106 words ▾

16 HOW SUPPLIED

16.1How Supplied LYVISPAH (baclofen) oral granules is supplied as follows: 5 mg white to off-white, strawberry flavored oral granules in a child-resistant single dose packet NDC 64896-076-09: carton of 90 packets 10 mg white to off-white, strawberry flavored oral granules in a child-resistant single dose packet NDC 64896-077-09: carton of 90 packets 20 mg white to off-white, strawberry flavored oral granules in a child-resistant single dose packet NDC 64896-078-09: carton of 90 packets

16.2Storage and Handling Store at room temperature, 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30º C (59ºF to 86ºF) [see USP Controlled Room Temperature].

📋 Description 103 words ▾

11 DESCRIPTION LYVISPAH (baclofen) oral granules is a gamma-aminobutyric acid (GABA-ergic) agonist available as 5 mg, 10 mg, or 20 mg of baclofen oral granules in a packet. Its chemical name is 4-amino-3-(4- chlorophenyl)-butanoic acid and its structural formula is: Molecular formula is C10H12ClNO2 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. LYVISPAH (baclofen) oral granules inactive ingredients include amino methacrylate copolymer, calcium stearate, colloidal silicon dioxide, crospovidone, hypromellose, mannitol, saccharin sodium, strawberry flavor, talc, and xylitol. chem structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). General Administration Instructions Instruct patient or caregiver to carefully open the LYVISPAH packet and empty the entire contents, to obtain the prescribed amount of medication. Packet contents can be administered directly into the mouth.

The contents of the packet can be swallowed or will dissolve in the mouth. LYVISPAH may be taken with liquids or can also be administered in soft foods if needed [see Dosage and Administration (2.2) ] . Administration Instructions with Soft Foods LYVISPAH can also be administered by mouth as a mixture with liquids or soft foods, such as apple sauce, yogurt, or pudding.

One packet can be mixed with up to 15 mL (one tablespoonful) of soft food. The mixture should be administered no more than 2 hours after mixing [see Dosage and Administration (2.2) ] . Administration Instructions via Feeding Tubes LYVISPAH can be administered via enteral feeding tubes, such a nasogastric (NG), gastrostomy (G), percutaneous endoscopic gastrostomy (PEG), and gastrojejunostomy (GJ) tubes.

Flush the feeding tube with up to 15 mL (one tablespoonful) of water. Open and empty the full contents of one packet of LYVISPAH in 15 mL (one tablespoonful) of the preferred liquid. Stir the suspension to ensure all granules are wetted.

Draw up the suspension of granules into a dosing syringe immediately after stirring and administer the dose via the feeding tube. Administer no longer than two hours after mixing. Refill the dosing syringe with 15 mL (one tablespoonful) of water and flush the feeding tube with the remaining contents.

Any unused suspensions should be discarded. Risks Related to Sudden Withdrawal of LYVISPAH Advise patients and caregivers not to discontinue use of LYVISPAH without consulting with their healthcare provider because sudden withdrawal of LYVISPAH 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 LYVISPAH 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 LYVISPAH 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 LYVISPAH or increasing the dose of LYVISPAH until they know how the drug affects them [see Warnings and Precautions (5.3) ] .

Inform patients and their caregivers that the drowsiness associated with LYVISPAH 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: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev.

04-2023-01

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.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

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.

Cmax: The highest level a medicine reaches in the blood after a dose is taken.

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.

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.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

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.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

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 Amneal labeler NDCsLabeler code 64896 📚 All gamma-Aminobutyric Acid-ergic Agonist NDCsDrug class 📖 Read the Baclofen drug informationUses, warnings & side effects

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