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Cyclobenzaprine Hydrochloride 10 mg Tablet, 1,000-count

by EXELAN PHARMACEUTICALS, INC. · 1000 TABLET in 1 BOTTLE (76282-283-10)

NDC 76282-0283-10

🏷️ FDA NDC (as labeled) 76282-283-10 billing pads the product segment with a zero

This package

Contains1,000-count Cost per ea$0.0170 NADAC Per package$17.00 / 1000 tablets Pack sizes6 compare ↓

Also priced by: Medicaid pays $9.96/unit — full pricing hub ↓

Also comes in: 30 tablets 76282-0283-30 60 tablets 76282-0283-60 90 tablets 76282-0283-90 180 tablets 76282-0283-18 270 tablets 76282-0283-27

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 76282-283-10

Product NDC 76282-283

11-digit billing NDC 76282028310

NCPDP billing unit EA — each (per item)

RxCUI 828348

UNII 0VE05JYS2P

UPC 0376282283272, 0376282283104, 0376282283906, 0376282283609

Application # ANDA090478

SPL Set ID cf81da00-7c6d-4477-bb70-b3c2abea177a

Established class (EPC) Muscle Relaxant

Physiologic effect Centrally-mediated Muscle Relaxation

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2025-04-10

Route ORAL

Dosage form TABLET

Substance CYCLOBENZAPRINE HYDROCHLORIDE

GPI-14 75100050100305

GCN Seq No 004681

GCN 18020

HICL code 001950

Ingredient (HICL) Cyclobenzaprine Hcl

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 12:20.04.00

AHFS class Centrally Acting Skeletal Muscle Relaxnt

FDB label name CYCLOBENZAPRINE 10 MG TABLET

FDB brand name Cyclobenzaprine Hcl

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 76282-283-10 — 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 → 76282-0283-10. 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 Muscle Relaxant class.

Pharmacologic class Muscle Relaxant

Drug family (ATC) Other centrally acting agents

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

LabelerEXELAN PHARMACEUTICALS, INC.

Application holderINVAGEN PHARMACEUTICALS INC

FDA applicationANDA090478 (ANDA)

Labeler code76282

First marketedApr 2025

Product typeHuman Prescription Drug

Portfolio78 products on file

🔎 All NDCs from EXELAN PHARMACEUTICALS, INC.

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 CYCLOBENZAPRINE 10 MG TABLET Ingredient Cyclobenzaprine Hcl

📖 What it is MedlinePlus · NLM

Cyclobenzaprine is used to treat muscle spasms. Cyclobenzaprine is in a class of medications called skeletal muscle relaxants. It works by acting in the brain and nervous system to allow the muscles to relax.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It's a muscle relaxant prescribed to help ease muscle spasms, pain, and stiffness from acute musculoskeletal injuries — like a back strain or a pulled muscle. It's meant to be used...
What is cyclobenzaprine actually used for?
Yes, drowsiness is one of the most common side effects — it's real and can be significant. You should not drive, operate heavy machinery, or do anything that requires sharp focus u...
Will this make me really drowsy? Can I drive?

📖 Read our full Cyclobenzaprine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

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

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

🌿 Every supplement checked against Cyclobenzaprine (197 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 yellow

ShapeRound

ImprintIG;283

Size7 mm

ScoringNot scored

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 EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
UNII 0VUT3PMY82
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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 O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 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 ea	Per package
Retail pharmacies payNADAC · weekly	$0.017	$17.00 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo	$9.96	$9,961.60 / 1000 tablets
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 4% over the last 9 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Cyclobenzaprine Hydrochloride 10 mg 00093-3422-01	Teva	100 tablets	$0.017	AB	Availability likely	—
Cyclobenzaprine Hydrochloride 10 mg 00904-7401-61	Major	1 tablet	$0.017	AB	Availability likely	—
Cyclobenzaprine Hydrochloride 10 mg 16571-0783-01	Rising	100 tablets	$0.017	AB	Availability likely	—
Cyclobenzaprine hydrochloride 10 mg 29300-0415-01	Unichem	100 tablets	$0.017	AB	Availability likely	—
Cyclobenzaprine Hydrochloride 10 mg 50268-0191-15	AvPAK	1 tablet	$0.017	AB	Availability likely	—
Cyclobenzaprine Hydrochloride 10 mg 52817-0332-00	TruPharma	1000 tablets	$0.017	AB	Availability likely	—
Cyclobenzaprine Hydrochloride 10 mg 59746-0177-06	Jubilant	100 tablets	$0.017	AB	Availability likely	—
Cyclobenzaprine Hydrochloride 10 mg 60687-0558-01	American	1 tablet	$0.017	AB	Availability likely	—
Cyclobenzaprine Hydrochloride 10 mg 64980-0657-01	Rising	100 tablets	$0.017	AB	Availability likely	—
Cyclobenzaprine Hydrochloride 10 mg 69097-0846-07	Cipla	100 tablets	$0.017	AB	Availability likely	—
Cyclobenzaprine Hydrochloride 10 mg 70512-0872-10	SOLA	100 tablets	$0.017	AB	Availability likely	—
Cyclobenzaprine Hydrochloride 10 mg 72603-0312-01	NORTHSTAR	100 tablets	$0.017	AB	Availability likely	—
Cyclobenzaprine Hydrochloride 10 mg 72888-0014-00	Advagen	1000 tablets	$0.017	AB	Availability likely	—
Cyclobenzaprine Hydrochloride 10 mgthis 76282-0283-10	EXELAN	1000 tablets	$0.017	AB	Availability likely	—
Cyclobenzaprine Hydrochloride 10 mg 10702-0007-01	KVK-TECH,	100 tablets	$0.022	AB	FDA listed	+27%
Cyclobenzaprine Hydrochloride 10 mg 00615-8084-05	NCS	15 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 42291-0154-10	AvKARE	1000 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 43547-0400-01	Solco	10 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 45865-0244-14	Medsource	14 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 50090-4722-00	A-S	15 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 50090-4727-00	A-S	15 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 50090-4729-01	A-S	12 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 50090-4730-00	A-S	90 tablets	—	AB	FDA listed	—
Cyclobenzaprine hydrochloride 10 mg 50090-5711-00	A-S	15 tablets	—	AB	FDA listed	—
Cyclobenzaprine hydrochloride 10 mg 50090-5712-00	A-S	3 tablets	—	AB	FDA listed	—
Cyclobenzaprine hydrochloride 10 mg 50090-5713-00	A-S	90 tablets	—	AB	FDA listed	—
Cyclobenzaprine hydrochloride 10 mg 50090-5772-00	A-S	15 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 50090-6864-00	A-S	90 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 51655-0539-20	Northwind	20 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 51655-0592-20	Northwind	20 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 51655-0973-87	Northwind	6 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 53746-0541-01	Amneal	100 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 55154-0190-00	Cardinal	1 tablet	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 60760-0767-04	ST.	4 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 62332-0647-31	Alembic	100 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 63187-0157-10	Proficient	10 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 63187-0812-07	Proficient	7 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 63629-1209-01	Bryant	1000 tablets	—	AB	Discontinued	—
Cyclobenzaprine Hydrochloride 10 mg 63629-1210-01	Bryant	500 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 63629-1211-01	Bryant	100 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 63629-9297-01	Bryant	1000 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 65162-0541-10	Amneal	100 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 65862-0191-01	Aurobindo	100 tablets	—	—	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 67046-1566-03	Coupler	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 67046-1645-03	Coupler	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine hydrochloride 10 mg 67296-1441-01	Redpharm	10 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 67296-1893-03	Redpharm	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 67296-2084-01	Redpharm	15 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 68071-2659-03	NuCare	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 68071-3150-01	NuCare	21 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 68071-3154-01	NuCare	10 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 68071-3404-03	NuCare	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 68071-3462-02	NuCare	20 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 68071-3561-04	NuCare	4 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 68071-3627-05	NuCare	15 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 68071-3973-07	NuCare	14 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 68071-3981-06	NuCare	6 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 68071-4935-06	NuCare	6 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 68071-4951-02	NuCare	20 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 68788-8167-02	Preferred	20 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 68788-8474-02	Preferred	20 tablets	—	AB	FDA listed	—
Cyclobenzaprine hydrochloride 10 mg 68788-8637-02	Preferred	20 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 69306-0872-03	Doc	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 70518-3415-00	REMEDYREPACK	30 tablets	—	AB	Discontinued	—
Cyclobenzaprine Hydrochloride 10 mg 70518-3474-00	REMEDYREPACK	1 tablet	—	AB	Discontinued	—
Cyclobenzaprine hydrochloride 10 mg 70518-3702-00	REMEDYREPACK	60 tablets	—	AB	Discontinued	—
Cyclobenzaprine Hydrochloride 10 mg 70518-3764-00	REMEDYREPACK	12 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 71205-0065-10	Proficient	10 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 71205-0201-10	Proficient	10 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 71335-1266-00	Bryant	40 tablets	—	AB	FDA listed	—
Cyclobenzaprine hydrochloride 10 mg 71335-1962-00	Bryant	40 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 71335-2110-00	Bryant	40 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 71335-2492-00	Bryant	40 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 71335-2666-00	Bryant	40 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 71335-2678-01	Bryant	5 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 71335-2686-01	Bryant	5 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 71610-0016-30	Aphena	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 71610-0428-45	Aphena	45 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 71610-0907-45	Aphena	45 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 71610-0933-45	Aphena	45 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 72162-1359-00	Bryant	1000 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 72189-0080-07	DIRECT	7 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 72189-0545-15	Direct_Rx	15 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 72789-0036-01	PD-Rx	100 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 72789-0046-03	PD-Rx	3 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 72789-0156-15	PD-Rx	15 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 76420-0011-01	Asclemed	1 tablet	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 76420-0033-01	Asclemed	1 tablet	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 76420-0271-01	Asclemed	1 tablet	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 76420-0599-02	Asclemed	2 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 76420-0830-00	Asclemed	1000 tablets	—	AB	FDA listed	—
Cyclobenzaprine hydrochloride 10 mg 76420-0841-00	Asclemed	1000 tablets	—	AB	FDA listed	—
Cyclobenzaprine HCL 10 mg 80425-0018-01	Advanced	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 80425-0019-01	Advanced	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 80425-0498-01	Advanced	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 80425-0547-01	Advanced	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 82461-0716-90	Medcore	90 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 82804-0259-30	Proficient	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 85509-1014-03	PHOENIX	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine hydrochloride 10 mg 85509-1415-03	PHOENIX	30 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 85766-0003-00	Sportpharm	1000 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 85766-0041-00	Sportpharm	1000 tablets	—	AB	FDA listed	—
Cyclobenzaprine Hydrochloride 10 mg 87441-0010-01	Unit	30 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2025

On the market since

Apr 2025

📍

2026

Currently FDA-listed

1 year listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

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

🗺️ 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 76282-0283-10, 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.

📅 Q2 2025 – Q1 2026 · 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

571

Units reimbursed last 4 qtrs

18.2K

Gross reimbursed last 4 qtrs

$180.9K

Avg / prescription

$316.78

Avg / unit

$9.9616

Latest quarter Q1 2026

152Rx

Medicaid pays / ea

$9.9616

gross reimbursed

NADAC / ea

$0.0170

acquisition cost

Spread

+$9.9446

+58498% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

52% FFS 48% MCO

Fee-for-service · 297 Rx Managed care · 274 Rx

State Medicaid map

Units reimbursed · per 100k residents

4.0620

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 New Mexico 620 /100k

2 Idaho 141 /100k

3 Alaska 103 /100k

4 Minnesota 21.4 /100k

5 Washington 4.0 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1000 tablets this page76282-0283-10 571 Rx · $180,882

90 tablets76282-0283-90 25 Rx · $258

180 tablets76282-0283-18 No Medicaid data

270 tablets76282-0283-27 No Medicaid data

30 tablets76282-0283-30 No Medicaid data

60 tablets76282-0283-60 No Medicaid data

Drug total (last 4 qtrs): 596 Rx · 19,354 units · $181,141 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
76282-0283-10 You're viewing this	1000 TABLET in 1 BOTTLE (76282-283-10)	$0.0170 / ea	$16.95	2025-04-10	Active
76282-0283-18	180 TABLET in 1 BOTTLE (76282-283-18)	$0.0170 / ea	$3.05	2025-04-10	Active
76282-0283-27	270 TABLET in 1 BOTTLE (76282-283-27)	$0.0170 / ea	$4.58	2025-04-10	Active
76282-0283-30	30 TABLET in 1 BOTTLE (76282-283-30)	$0.0170 / ea	$0.51	2025-04-10	Active
76282-0283-60	60 TABLET in 1 BOTTLE (76282-283-60)	$0.0170 / ea	$1.02	2025-04-10	Active
76282-0283-90	90 TABLET in 1 BOTTLE (76282-283-90)	$0.0170 / ea	$1.53	2025-04-10	Active

You're viewing the largest of 6 pack sizes for this product.

This pack has the lowest per-ea cost of the 6 priced pack sizes ($0.0170 NADAC).

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Pack size FAQ

What quantity is in NDC 76282-0283-10?

NDC 76282-0283-10 is a 1,000-count package — 1000 tablet in 1 bottle.

What is the difference between NDC 76282-0283-10 and NDC 76282-0283-30?

Both are Cyclobenzaprine Hydrochloride 10 mg Tablet — the drug itself is identical. NDC 76282-0283-10 is the 1,000-count package, while NDC 76282-0283-30 is the 30 tablets package.

What NDC number is used to bill for this package of Cyclobenzaprine Hydrochloride 10 mg Tablet?

Bill NDC 76282-0283-10 — the 11-digit billing format is 76282028310. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description

🎯 Indications and Usage 130 words ▾

INDICATIONS AND USAGE Cyclobenzaprine hydrochloride tablets,USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.

Cyclobenzaprine hydrochloride have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.

⏱️ Dosage and Administration 84 words ▾

DOSAGE & ADMINISTRATION For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets USP is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets USP for periods longer than two or three weeks is not recommended.

(see INDICATIONS AND USAGE ). Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS : Impaired Hepatic Function, and Use in the Elderly ).

⛔ Contraindications 63 words ▾

CONTRAINDICATIONS Hypersensitivity to any component of this product. Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation. Hyperpyretic crisis seizures, and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitor drugs.

Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. Hyperthyroidism.

⚠️ Warnings ~1 min read ▾

WARNINGS Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with Cyclobenzaprine Hydrochloride when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. The concomitant use of cyclobenzaprine hydrochloride with MAO inhibitors is contraindicated (see CONTRAINDICATIONS ) . Serotonin syndrome symptoms may include mental status changes (e.g., confusion, agitation, hallucinations), autonomic instability (e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity), and /or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Treatment with Cyclobenzaprine Hydrochloride and any concomitant serotonergic agents should be discontinued immediately if the above reactions occur and supportive symptomatic treatment should be initiated. If concomitant treatment with Cyclobenzaprine Hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see PRECAUTIONS , Drug Interactions ). Cyclobenzaprine is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine.

In short term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred (see WARNINGS , below, and ADVERSE REACTIONS ) . Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.

Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Incidence of most common adverse reactions in the 2 double-blind‡, placebo-controlled 5 mg studies (incidence of > 3% on cyclobenzaprine hydrochloride tablets, 5 mg): Cyclobenzaprine HCI Tablets 5 mg Cyclobenzaprine HCI Tablets 10 mg Placebo N=464 N=249 N=469 Drowsiness 29% 38% 10% Dry Mouth 21% 32% 7% Fatigue 6% 6% 3% Headache 5% 5% 8% Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.

The following list of adverse reactions is based on the experience in 473 patients treated with cyclobenzaprine hydrochloride tablets, 10 mg in additional controlled clinical studies, 7607 patients in the postmarketing surveillance program, and reports received since the drug was marketed. The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies. The adverse reactions reported most frequently with cyclobenzaprine hydrochloride were drowsiness, dry mouth and dizziness.

The incidence of these common adverse reactions was lower in the surveillance program than in the controlled clinical studies: ‡ Note: Cyclobenzaprine Hydrochloride tablets, 10 mg data are from one clinical trial. Cyclobenzaprine Hydrochloride tablets, 5 mg and placebo data are from two studies . Clinical Studies With Cyclobenzaprine HCI Tablets, 10 mg Surveillance Program With Cyclobenzaprine HCI Tablets, 10 mg N=464 N=249 Drowsiness 39% 16% Dry Mouth 27% 7% Dizziness 11% 3% Among the less frequent adverse reactions, there was no appreciable difference in incidence in controlled clinical studies or in the surveillance program.

Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion. The following adverse reactions have been reported in post-marketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg tablet: Body as a Whole: Syncope; malaise. Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension.

Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis. Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash. Musculoskeletal: Local weakness.

Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome. Skin: Sweating. Special Senses: Ageusia; tinnitus.

Urogenital: Urinary frequency and/or retention. Causal Relationship Unknown Other reactions, reported rarely for cyclobenzaprine hydrochloride under circumstances where a causal relationship could not be established or reported for other tricyclic drugs, are listed to serve as alerting information to physicians: Body as a whole: Chest pain; edema. Cardiovascular: Hypertension; myocardial infarction; heart block; stroke.

Digestive: Paralyticileus; tongue discoloration; stomatitis; parotid swelling. Endocrine: Inappropriate ADH syndrome. Hematic and Lymphatic: Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia.

Metabolic, Nutritional and Immune: Elevation and lowering of blood sugar levels; weight gain or loss. Musculoskeletal: Myalgia. Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell’s palsy; alteration in EEG patterns; extrapyramidal symptoms.

Respiratory: Dyspnea. Skin: Photo…

🆘 Overdosage ~2 min read ▾

OVERDOSAGE Although rare, deaths may occur from overdosage with cyclobenzaprine hydrochloride. Multiple drug ingestion (including alcohol) is common in deliberate cyclobenzaprine overdose. As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment.

Signs and symptoms of toxicity may develop rapidly after cyclobenzaprine overdose; therefore, hospital monitoring is required as soon as possible. The acute oral LD 50 of cyclobenzaprine hydrochloride is approximately 338 and 425 mg/kg in mice and rats, respectively. Manifestations The most common effects associated with cyclobenzaprine overdose are drowsiness and tachycardia.

Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations. Rare but potentially critical manifestations of overdose are cardiac arrest, chest pain, cardiac dysrhythmias, severe hypotension, seizures, and neuroleptic malignant syndrome. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of cyclobenzaprine toxicity.

Other potential effects of overdosage include any of the symptoms listed under ADVERSE REACTIONS . Management General As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. In order to protect against the rare but potentially critical manifestations described above, obtain an ECG and immediately initiate cardiac monitoring.

Protect the patient’s airway, establish an intravenous line and initiate gastric decontamination. Observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/ or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required.

Monitoring of plasma drug levels should not guide management of the patient. Dialysis is probably of no value because of low plasma concentrations of the drug. Gastrointestinal Decontamination All patients suspected of an overdose with cyclobenzaprine hydrochloride should receive gastrointestinal decontamination.

This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage and emesis is contraindicated. Cardiovascular A maximal limb-lead QRS duration of ≥0.10 seconds may be the best indication of the severity of the overdose.

Serum alkalinization, to a pH of 7.45 to 7.55, using intravenous sodium bicarbonate and hyperventilation (as needed), should be instituted for patients with dysrhythmias and/or QRS widening. A pH >7.60 or a pCO 2 <20 mmHg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin.

Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide). CNS In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines or, if these are ineffective, other anticonvulsants (e.g. phenobarbital, phenytoin).

Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in close consultation with a poison control center. Psychiatric Follow-up Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

Pediatric Management The principles of management of child and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease. Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models.Animal studies indicate that cyclobenzaprine does not act at the neuromuscular junction or directly on skeletal muscle.

Such studies show that cyclobenzaprine acts primarily within the central nervous system at brain stem as opposed to spinal cord levels, although its action on the latter may contribute to its overall skeletal muscle relaxant activity. Evidence suggests that the net effect of cyclobenzaprine is a reduction of tonic somatic motor activity, influencing both gamma (γ) and alpha (α) motor systems. Pharmacological studies in animals showed a similarity between the effects of cyclobenzaprine and the structurally related tricyclic antidepressants, including reserpine antagonism, norepinephrine potentiation, potent peripheral and central anticholinergic effects, and sedation.

Cyclobenzaprine caused slight to moderate increase in heart rate in animals. Pharmacokinetics Estimates of mean oral bioavailability of cyclobenzaprine range from 33% to 55%. Cyclobenzaprine exhibits linear pharmacokinetics over the dose range 2.5 mg to 10 mg, and is subject to enterohepatic circulation.

It is highly bound to plasma proteins. Drug accumulates when dosed three times a day, reaching steady-state within 3-4 days at plasma concentrations about four-fold higher than after a single dose. At steady-state in healthy subjects receiving 10 mg t.i.d.

(n=18), peak plasma concentration was 25.9 ng/mL (range, 12.8-46.1ng/mL), and area under the concentration-time (AUC) curve over an 8-hour dosing interval was 177 ng.hr/mL (range, 80-319 ng.hr/mL). Cyclobenzaprine is extensively metabolized, and is excreted primarily as glucuronides via the kidney. Cytochromes P-450 3A4, 1A2, and, to a lesser extent, 2D6, mediate N-demethylation, one of the oxidative pathways for cyclobenzaprine.

Cyclobenzaprine is eliminated quite slowly, with an effective half-life of 18 hours (range 8-37 hours; n=18); plasma clearance is

0.7L/min. The plasma concentration of cyclobenzaprine is generally higher in the elderly and in patients with hepatic impairment. (See PRECAUTIONS , Use in the Elderly and PRECAUTIONS , Impaired Hepatic Function) Elderly In a pharmacokinetic study in elderly individuals (≥65yrs old), mean (n=10) steady-state cyclobenzaprine AUC values were approximately 1.7 fold (171 ng.hr/mL, range 96.1- 255.3) higher than those seen in a group of eighteen younger adults (101.4 ng.hr/mL, range 36.1-182.9) from another study.

Elderly male subjects had the highest observed mean increase, approximately 2.4 fold (198.3 ng.hr/mL, range 155.6-255.3 versus 83.2 ng.hr/mL, range 41.1-142.5 for younger males) while levels in elderly females were increased to a much lesser extent, approximately 1.2 fold (143.8 ng.hr/mL, range 96.1-196.3 versus 115.9 ng.hr/mL, range 36.1-182.9 for younger females). In light of these findings, therapy with cyclobenzaprine hydrochloride in the elderly should be initiated with a 5 mg dose and titrated slowly upward. Hepatic Impairment In a pharmacokinetic study of sixteen subjects with hepatic impairment (15 mild, 1 moderate per Child-Pugh score), both AUC and C max were approximately double the values seen in the healthy control group.

Based on the findings, cyclobenzaprine hydrochloride should be used with caution in subjects with mild hepatic impairment starting with the 5 mg dose and titrating slowly upward. Due to the lack of data in subjects with more severe hepatic insufficiency, the use of cyclobenzaprine hydrochloride in subjects with moderate to severe impairment is not recommended. No significant effect on plasma levels or bioavailability of cyclobenzaprine hydrochloride or aspirin was noted when single or multiple doses of th…

📦 How Supplied / Storage and Handling 90 words ▾

HOW SUPPLIED Cyclobenzaprine hydrochloride tablets USP are available in 10 mg dosage strength. The 10 mg tablets are yellow colored, film coated, round, biconvex tablets debossed with ‘IG’ on one side and “283” on other. The dosage strength is supplied as follows: 10 mg - 30 count bottle NDC 76282-283-30 10 mg - 60 count bottle NDC 76282-283-60 10 mg - 90 count bottle NDC 76282-283-90 10 mg - 180 count bottle NDC 76282-283-18 10 mg - 270 count bottle NDC 76282-283-27 10 mg - 1000 count bottle NDC 76282-283-10

📦 Storage and Handling 40 words ▾

STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Rx Only Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Exelan Pharmaceuticals, Inc. Boca Raton, FL 33432 Revised: 01/2025

📋 Description 141 words ▾

DESCRIPTION Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20 H 21 N•HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents.

If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5 ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80). structure

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.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

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

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

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

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

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

asthenia: Unusual weakness or lack of physical strength and energy.

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.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

Child-Pugh: A scoring system doctors use to grade how severe long-term liver disease is, often to help set the right medicine dose.

cholestasis: A slowing of bile flow out of the liver; bile is the fluid that helps digest fat, and this backup can cause itching and yellow skin.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

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

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

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.

diaphoresis: Heavy or excessive sweating.

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

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

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

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.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

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

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

electrocardiogram: A quick, painless test that records the heart's electrical activity to check its rhythm and rate.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

extrapyramidal symptoms: Movement problems caused by certain medicines, such as stiffness, tremor, restlessness, or unusually slow movements.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

gastritis: Swelling or irritation of the lining of the stomach.

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

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hyperreflexia: Overactive or exaggerated reflexes, such as an unusually strong knee-jerk response.

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

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hyperthyroidism: A condition where the thyroid gland makes too much thyroid hormone, which can speed the body up.

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.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

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

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

linear pharmacokinetics: When blood levels of a medicine rise in direct proportion to the size of the dose.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

myalgia: Muscle pain or aching.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

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

neuroleptic malignant syndrome: A rare but serious reaction to certain medicines causing high fever, severe muscle stiffness, confusion, and an unstable heartbeat.

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.

peripheral neuropathy: Damage to the nerves outside the brain and spinal cord, often causing numbness, tingling, or pain in the hands and feet.

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.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

postmarketing surveillance: Tracking of a medicine's safety after it is approved and being used by the general public.

pruritus: Itching of the skin.

psychosis: A state of losing touch with reality, such as seeing or hearing things that are not there or holding false beliefs.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

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

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

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

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

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

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

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

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

urticaria: Raised, itchy welts on the skin, commonly called hives.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

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

← 76282-0281-10 · EXELAN 76282-0302-01 · Exelan →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Cyclobenzaprine Hydrochloride 10 mg Tablet, 1,000-count

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