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Cyclobenzaprine Hydrochloride 5 mg Tablet, Film Coated, 500-count

by Bryant Ranch Prepack · 500 TABLET, FILM COATED in 1 BOTTLE (63629-1212-1)
NDC 63629-1212-01
🏷️ FDA NDC (as labeled) 63629-1212-1 billing pads the package segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 9, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Cyclobenzaprine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Aug 27, 2025 — Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). (Unichem Pharmaceuticals USA Inc.) · FDA recall D-0655-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 63629-1212-1
Product NDC 63629-1212
11-digit billing NDC 63629121201
NCPDP billing unit EA — each (per item)
RxCUI 828320
UNII 0VE05JYS2P
Application # ANDA077797
SPL Set ID 8b58cd96-1371-441f-b38c-5b18dde98bbc
Established class (EPC) Muscle Relaxant
Physiologic effect Centrally-mediated Muscle Relaxation
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 2017-03-30
Route ORAL
Dosage form TABLET, FILM COATED
Substance CYCLOBENZAPRINE HYDROCHLORIDE
GPI-14 75100050100303
GPI class Cyclobenzaprine HCl
GCN Seq No 047478
GCN 12805
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 5 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 63629-1212-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 63629-1212-01. 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

LabelerBryant Ranch Prepack
Application holderPRINSTON PHARMACEUTICAL INC
FDA applicationANDA077797 (ANDA)
Labeler code63629
First marketedMar 2017
Product typeHuman Prescription Drug
Portfolio4,434 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CYCLOBENZAPRINE 5 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cyclobenzaprine Hydrochloride 5 mg 00093-3420-01 Teva 100 tablets $0.021 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 00904-7400-04 Major 1 tablet $0.021 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 10702-0006-01 KVK-TECH, 100 tablets $0.021 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 16571-0782-01 Rising 100 tablets $0.021 AB Availability likely —
Cyclobenzaprine hydrochloride 5 mg 29300-0413-01 Unichem 100 tablets $0.021 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 50268-0190-15 AvPAK 1 tablet $0.021 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 52817-0330-10 TruPharma 100 tablets $0.021 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 59746-0211-06 Jubilant 100 tablets $0.021 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 64980-0655-01 Rising 100 tablets $0.021 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 68084-0753-25 American 1 tablet $0.021 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 69097-0845-07 Cipla 100 tablets $0.021 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 72603-0310-01 NORTHSTAR 100 tablets $0.021 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 72888-0012-00 Advagen 1000 tablets $0.021 AB Availability likely —
Cyclobenzaprine hydrochloride 5 mg 00615-8508-05 NCS 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 42708-0172-20 QPharma 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 42708-0197-20 QPharma, 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 43063-0494-01 PD-Rx 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 43547-0399-01 Solco 10 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 5 mg 50090-5756-00 A-S 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 51655-0427-26 Northwind 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 51655-0818-26 Northwind 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 53746-0540-01 Amneal 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 60429-0876-01 Golden 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 60760-0766-04 ST. 4 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 62332-0646-31 Alembic 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 63187-0094-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mgthis 63629-1212-01 Bryant 500 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 5 mg 63629-1213-01 Bryant 100 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 5 mg 63629-2424-01 Bryant 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 65162-0540-10 Amneal 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 65862-0190-01 Aurobindo 100 tablets — — FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 67046-1110-03 Coupler 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 68071-2790-02 NuCare 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 68071-3475-02 NuCare 12 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 5 mg 68071-3567-02 NuCare 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 68071-3915-02 NuCare 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 68071-4655-02 NuCare 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 68788-8221-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 68788-8471-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 5 mg 68788-8706-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 70518-2611-01 REMEDYREPACK 90 tablets — AB Discontinued —
Cyclobenzaprine hydrochloride 5 mg 70518-3251-00 REMEDYREPACK 90 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 5 mg 70518-3814-00 REMEDYREPACK 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 71205-0356-15 Proficient 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 71205-0678-30 Proficient 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 71335-1099-00 Bryant 100 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 5 mg 71335-1961-00 Bryant 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 71335-2156-00 Bryant 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 71335-2479-00 Bryant 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 72162-1358-01 Bryant 100 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 5 mg 72162-1692-00 Bryant 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 72189-0280-30 DirectRx 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 72189-0283-20 DirectRx 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 72789-0073-30 PD-Rx 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 72789-0115-10 PD-Rx 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 72789-0547-21 PD-Rx 21 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 76420-0030-01 Asclemed 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 76420-0269-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 76420-0828-00 Asclemed 1000 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 5 mg 76420-0839-00 Asclemed 1000 tablets — AB FDA listed —
Cyclobenzaprine HCL 5 mg 80425-0016-01 Advanced 60 tablets — AB FDA listed —
Cyclobenzaprine HCL 5 mg 80425-0017-01 Advanced 60 tablets — AB FDA listed —
Cyclobenzaprine HCL 5 mg 80425-0155-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 82461-0714-90 Medcore 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 82868-0008-30 Northwind 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 85534-0005-00 HAWAII 30 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 5 mg 85766-0272-01 Sportpharm 100 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

🏛️
2017
On the market since
Mar 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

🔬 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 Cyclobenzaprine hydrochloride — the ingredient across all brands.

Top reported reactions

Pain1,392
Headache1,075
Fatigue1,060
Nausea732
Constipation710
Back Pain646
Fall626

Age at onset

Neonate1
Infant1
Child4
Adolescent10
Adult1,568
Elderly781

Reporter sex

8,933 reports
Male · 23%
Female · 77%
Unknown · 0%

Serious outcomes

Hospitalization2,302
Death731
Life-threatening259
Disabling233
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,161 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63629-1212-01 You're viewing this 500 TABLET, FILM COATED in 1 BOTTLE (63629-1212-1) 2021-01-14 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 63629-1212-1, 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: 63629-1212-01, written without dashes as 63629121201. 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 63629-1212-01, the first segment (63629) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (1212) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 132 words ▾

INDICATIONS AND USAGE Cyclobenzaprine hydrochloride tablets 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 tablets 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 tablets 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 82 words ▾

DOSAGE AND ADMINISTRATION For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 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 monoamine oxidase (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 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 Hydrochloride Tablets 5 mg N=464 Cyclobenzaprine Hydrochloride Tablets 10 mg N=249 Placebo 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 post-marketing 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 Hydrochloride Tablets 10 mg Surveillance Program with Cyclobenzaprine Hydrochloride Tablets 10 mg 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: Paralytic ileus; 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.

Respirat…

🔄 Drug Interactions 118 words ▾

Drug Interactions Cyclobenzaprine may have life threatening interactions with MAO inhibitors (see CONTRAINDICATIONS ). Postmarketing cases of serotonin syndrome have been reported during combined use of Cyclobenzaprine Hydrochloride and other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or monoamine oxidase (MAO) inhibitors. 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 WARNINGS ).

Cyclobenzaprine may enhance the effects of alcohol, barbiturates, and other CNS depressants. Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds. Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.

🤰 Pregnancy 1 words ▾

Pregnancy

🧒 Pediatric Use 20 words ▾

Pediatric Use Safety and effectiveness of cyclobenzaprine hydrochloride in pediatric patients below 15 years of age have not been established.

🧓 Geriatric Use 79 words ▾

Use in the Elderly The plasma concentration of cyclobenzaprine is increased in the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly ). The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions. For these reasons, in the elderly, cyclobenzaprine should be used only if clearly needed.

In such patients cyclobenzaprine should be initiated with a 5 mg dose and titrated slowly upward.

🆘 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.

MANIFESTATIONS The most common effects associated with cyclobenzaprine…

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Cyclobenzaprine HCl 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, 12.8-46.1 ng/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 (≥65 yrs old), mean (n=10) steady state cyclobenzaprine AUC values were approximately 1.7-fold (171.0 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 tablets 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 tablets 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 tablets in subjects with moderate to severe impairment is not recommended.

No significant effect on plasma levels or bioavailability of cyclobenzaprine hydrochloride tablets or aspirin was noted when sing…

📦 How Supplied / Storage and Handling 52 words ▾

HOW SUPPLIED Cyclobenzaprine Hydrochloride Tablets, USP 5 mg round, orange film-coated tablets, debossed "2631" on one side and debossed "V" on the reverse side. They are supplied as follows: Bottles of 500: NDC 63629-1212-1 You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

📦 Storage and Handling 9 words ▾

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

📋 Description 149 words ▾

DESCRIPTION Cyclobenzaprine hydrochloride 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 HCl 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 Tablets, USP are supplied as 5 mg and 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide; 5 mg tablets also contain FD&C Red #40 and 10 mg tablets contain D&C Yellow #10 and polysorbate.

💬 Information for Patients 155 words ▾

Information for Patients Cyclobenzaprine hydrochloride tablets, especially when used with alcohol or other CNS depressants, may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. In the elderly, the frequency and severity of adverse events associated with the use of cyclobenzaprine, with or without concomitant medications, is increased. In elderly patients, cyclobenzaprine hydrochloride tablets should be initiated with a 5 mg dose and titrated slowly upward.

Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Cyclobenzaprine Hydrochloride and other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or monoamine oxidase (MAO) inhibitors. Patients should be advised of the signs and symptoms of serotonin syndrome, and be instructed to seek medical care immediately if they experience these symptoms (see WARNINGS , and see PRECAUTIONS, Drug Interactions ).

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63629-1211-01 · Bryant 63629-1213-01 · Bryant →
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.