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Cyclobenzaprine Hydrochloride 5 mg Tablet, Film Coated — NDC 68084-0753-25 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cyclobenzaprine Hydrochloride 5 mg Tablet, Film Coated — NDC 68084-753-25 (Billing 68084-0753-25)

by American Health Packaging · 30 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Cyclobenzaprine Hydrochloride 5 mg Tablet, Film Coated from American Health Packaging, marketed since Jan 2016 and currently FDA-listed; retail pharmacies pay about $0.0220 per unit (NADAC).

NDC 68084-0753-25
🏷️ FDA NDC (as labeled) 68084-753-25 billing pads the product segment with a zero
This package
Contains1 tablet, film coated in 1 blister pack Cost per ea$0.0220 NADAC Per package$0.66 / 30 tablet Pack sizes2 compare ↓
Also priced by: Medicaid pays $6.08/unit · Part D plans $0.1547/unit — full pricing hub ↓
Product page 68084-0753-65 Also comes in: 1 tablet 68084-753-65
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for 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 ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68084-753-25
Product NDC 68084-753
11-digit billing NDC 68084075325
NCPDP billing unit EA — each (per item)
RxCUI 828320
UNII 0VE05JYS2P
Application # ANDA078048
SPL Set ID 5f321a03-ccfb-4c11-ac60-a461a5580c69
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 2016-01-04
Route ORAL
Dosage form TABLET, FILM COATED
Substance CYCLOBENZAPRINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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
Quick answers
  • GSN (GCN sequence number): 047478
  • GCN: 12805
  • GPI-14 (Medi-Span): 75100050100303
  • HICL (First Databank): 001950
  • AHFS class code: 12:20.04.00
  • RxCUI (RxNorm): 828320
Why two NDCs? The FDA registers this code as 68084-753-25 — 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 → 68084-0753-25. 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.

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
  • Cyclobenzaprine tablets and extended-release capsules ease muscle spasm from recent, painful muscle or joint problems. You use them with rest and physical therapy. Tonmya, a differ...
  • For muscle spasm, it's meant for short-term use only, about two or three weeks. Spasms usually improve in that time, and there's no good evidence it works longer.
  • Dry mouth, drowsiness, dizziness, tiredness, constipation and nausea are the most common. Be careful driving until you know how it affects you. Call your doctor if side effects bot...
  • Alcohol and other sedating medicines can make it stronger, so avoid mixing them. Tell me about any antidepressants, tramadol or other related medicines, because of the risk of sero...
📖 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.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.022 $0.66 / 30 tablet
Medicaid paysCMS SDUD · 12 mo $6.08 $182.43 / 30 tablet
Medicare drug plans payPart D · Q2 2026 $0.1547 $4.64 / 30 tablet
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.030 $0.021
▼ Down 27% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
68084-0753-25 You're viewing this 30 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED in 1 BLISTER PACK $0.0220 / ea $0.66 2016-01-04 — Active
68084-0753-65 68084-753-65 Main listing 50 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK $0.0220 / ea $1.10 2024-03-27 — Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0220 NADAC).

This pack accounts for about 9.5% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 30 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Cyclobenzaprine Hydrochloride 5 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cyclobenzaprine Hydrochloride 5 mg 00093-3420-01 Teva 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 00904-7400-04 Major 1 tablet $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 10702-0006-01 KVK-TECH, 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 16571-0782-01 Rising 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine hydrochloride 5 mg 29300-0413-01 Unichem 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 50268-0190-15 AvPAK 1 tablet $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 52817-0330-10 TruPharma 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 59746-0211-06 Jubilant 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 64980-0655-01 Rising 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mgthis 68084-0753-25 American 1 tablet $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 69097-0845-07 Cipla 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 72603-0310-01 NORTHSTAR 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 72888-0012-00 Advagen 1000 tablets $0.022 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 mg 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

🏛️
2016
On the market since
Jan 2016
📍
2026
Currently FDA-listed
10 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.

What it looks like

Color orange
ShapeRound
ImprintK;6
Size8 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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 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 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 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.

13 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.

Manufacturer & labeler

LabelerAmerican Health Packaging
Application holderKVK TECH INC
FDA applicationANDA078048 (ANDA)
Labeler code68084
First marketedJan 2016
Product typeHuman Prescription Drug
Portfolio673 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 📋 Description ⚠️ Precautions 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 135 words ▾

INDICATIONS AND USAGE Cyclobenzaprine hydrochloride tablets, USP is 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, USP 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, USP 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 85 words ▾

DOSAGE AND 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 PRECAUTIONS 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 tablets, USP 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, USP 5 mg): Cyclobenzaprine hydrochloride tablets, USP Cyclobenzaprine hydrochloride tablets, USP 5 mg 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, USP 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 tablets, USP 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, USP 10 mg data are from one clinical trial. Cyclobenzaprine hydrochloride tablets, USP 5 mg and placebo data are from two studies. Clinical Studies With Cyclobenzaprine hydrochloride tablets, USP 10 mg Surveillance Program With Cyclobenzaprine hydrochloride tablets, USP 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 tablets, USP 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 pa… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage ~2 min read ▾

OVERDOSAGE Although rare, deaths may occur from overdosage with Cyclobenzaprine hydrochloride tablets, USP. 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 tablets, USP 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 of low plasma concentrations of the drug. Gastrointestinal Decontamination All patients suspected of an overdose with Cyclobenzaprine hydrochloride tablets, USP 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, 12.8-46.1 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 (≥65yrs 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, USP 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, USP 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, USP in subjects with moderate to severe impairment is not recommended.

No significant effect on plasma levels or bioavailability of Cyclobenzaprine hydrochloride tablets, USP… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 84 words ▾

HOW SUPPLIED Cyclobenzaprine hydrochloride tablets, USP are available in 5 mg dosage strength. The 5 mg tablets are supplied as orange film coated round shaped biconvex tablets debossed “K 6” on one side and plain on other side. Unit dose packages of 30 (5 x 6) NDC 68084-753-25 Unit dose packages of 50 (5 x 10) NDC 68084‐753‐65 Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

📋 Description 189 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 pKa 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 is designated chemically as 3-( 5H -dibenzo [ a,d ] cyclohepten-5-ylidene)- N,N -dimethyl-1-propanamine hydrochloride, and has the following structural formula: Each 5 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 5 mg Cyclobenzaprine hydrochloride. Each 10 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 10 mg Cyclobenzaprine hydrochloride.

Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, carnauba wax, titanium dioxide, polyethylene glycol, and iron oxide yellow. In addition, 5 mg tablets also contain polyvinyl alcohol, talc, lecithin, and FD&C yellow # 6 / sunset yellow FCF aluminum lake. In addition, 10 mg tablets also contain D&C yellow # 10 aluminum lake, FD&C yellow # 6 aluminum lake, and hypromellose.

Structural Formula

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Because of its atropine-like action, Cyclobenzaprine hydrochloride tablets, USP should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication. Impaired Hepatic Function The plasma concentration of cyclobenzaprine is increased in patients with hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics and CLINICAL PHARMACOLOGY, Hepatic Impairment ). These patients are generally more susceptible to drugs with potentially sedating effects, including cyclobenzaprine.

Cyclobenzaprine hydrochloride tablets, USP should be used with caution in subjects with mild hepatic impairment starting with a 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, USP in subjects with moderate to severe impairment is not recommended. Information for Patients Cyclobenzaprine hydrochloride tablets, USP, 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, USP 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 SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or 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 ). 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 SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or 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 hydrochloride tablets, USP 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. † † ULTRAM ® (tramadol HCl tablets, Ortho-McNeil Pharmaceutical) ULTRACET ® (tramadol HCl and acetaminophen tablets, Ortho-McNeil Pharmaceutical) Carcinogenesis, Mutagenesis, Impairment of Fertility In rats treated with Cyclobenzaprine hydrochloride tablets, USP for up to 67 weeks at doses of approximately 5 to 40 times the maximum recommended human dose, pale, sometimes enlarged, livers were noted and there was a dose-related hepatocyte vacuolation with lipidosis.

In the higher dose groups this microscopic change was seen after 26 weeks and even earlier in rats which died prior to 26 weeks; at lower doses, the change was not seen until after 26 weeks. Cyclobenzaprine did not affect the onset, incidence or distribution of neoplasia in an 81-week study in the mouse or in a 105-week study in the rat. At oral doses of up to 10 times the human dose, cyclobenzaprine did not adversely affect the reproductive performance or fertility of male or female rats.

Cyclobenzaprine did not demonstrate mutagenic activity in the male mouse at dose levels of up to 20 times the human dose. Pregnancy Pregnancy Category B: Reproduct… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~2 min read ▾

CLINICAL STUDIES Eight double-blind controlled clinical studies were performed in 642 patients comparing Cyclobenzaprine hydrochloride tablets, USP 10 mg, diazepam**, and placebo. Muscle spasm, local pain and tenderness, limitation of motion, and restriction in activities of daily living were evaluated. In three of these studies there was a significantly greater improvement with Cyclobenzaprine hydrochloride tablets, USP than with diazepam, while in the other studies the improvement following both treatments was comparable.

Although the frequency and severity of adverse reactions observed in patients treated with Cyclobenzaprine hydrochloride tablets, USP were comparable to those observed in patients treated with diazepam, dry mouth was observed more frequently in patients treated with Cyclobenzaprine hydrochloride tablets, USP and dizziness more frequently in those treated with diazepam. The incidence of drowsiness, the most frequent adverse reaction, was similar with both drugs. The efficacy of Cyclobenzaprine hydrochloride tablets, USP 5 mg was demonstrated in two seven-day, double-blind, controlled clinical trials enrolling 1405 patients.

One study compared Cyclobenzaprine hydrochloride tablets, USP 5 and 10 mg t.i.d. to placebo; and a second study compared Cyclobenzaprine hydrochloride tablets, USP 5 and 2.5 mg t.i.d. to placebo. Primary endpoints for both trials were determined by patient-generated data and included global impression of change, medication helpfulness, and relief from starting backache. Each endpoint consisted of a score on a 5-point rating scale (from 0 or worst outcome to 4 or best outcome).

Secondary endpoints included a physician’s evaluation of the presence and extent of palpable muscle spasm. Comparisons of Cyclobenzaprine hydrochloride tablets, USP 5 mg and placebo groups in both trials established the statistically significant superiority of the 5 mg dose for all three primary endpoints at day 8 and, in the study comparing 5 and 10 mg, at day 3 or 4 as well. A similar effect was observed with Cyclobenzaprine hydrochloride tablets, USP 10 mg (all endpoints).

Physician-assessed secondary endpoints also showed that Cyclobenzaprine hydrochloride tablets, USP 5 mg were associated with a greater reduction in palpable muscle spasm than placebo. Analysis of the data from controlled studies shows that Cyclobenzaprine hydrochloride tablets, USP produce clinical improvement whether or not sedation occurs. **VALIUM ® (diazepam, Roche) Surveillance Program A post-marketing surveillance program was carried out in 7607 patients with acute musculoskeletal disorders, and included 297 patients treated with Cyclobenzaprine hydrochloride tablets, USP 10 mg for 30 days or longer.

The overall effectiveness of Cyclobenzaprine hydrochloride tablets, USP was similar to that observed in the double-blind controlled studies; the overall incidence of adverse effects was less (see ADVERSE REACTIONS ).

🔒 Drug Abuse and Dependence 56 words ▾

DRUG ABUSE AND DEPENDENCE Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when Cyclobenzaprine hydrochloride tablets, USP are administered, even though they have not been reported to occur with this drug. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. These are not indicative of addiction.

📄 Package Label / Principal Display Panel ~1 min read ▾

Package/Label Display Panel – Carton – 5 mg – 30 UD NDC 68084- 753 -25 Cyclobenzaprine Hydrochloride Tablets, USP 5 mg 30 Tablets (5 x 6) Rx Only Each Tablet Contains: Cyclobenzaprine Hydrochloride, USP................5 mg Usual Adult Dosage: One tablet (5 mg) three times a day. See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 10702-006, KVK-Tech, Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 075325 0275325/1224 5 mg Cyclobenzaprine Tablets Carton- 5x6

Package/Label Display Panel – Blister – 5 mg – 6 UD Cyclobenzaprine Hydrochloride Tablet, USP 5 mg 5 mg Cyclobenzaprine Hydrochloride Tablet Blister - 6 UD

Package/Label Display Panel – Carton – 5 mg – 50 UD NDC 68084- 753 -65 Cyclobenzaprine Hydrochloride Tablets, USP 5 mg 50 Tablets (5 x 10) Rx Only Each Tablet Contains: Cyclobenzaprine Hydrochloride, USP....................................... 5 mg Usual Adult Dosage: One tablet (5 mg) three times a day. See full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 10702-006, KVK-Tech, Inc.

Distributed by: American Health Packaging, Columbus, Ohio 43217 075365 0275365/1024 5 mg Cyclobenzaprine Tablets Carton- 5x10

Package/Label Display Panel – Blister – 5 mg – 10 UD Cyclobenzaprine Hydrochloride Tablet, USP 5 mg 5 mg Cyclobenzaprine Hydrochloride Tablet Blister - 10 UD

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

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 this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
11
Units reimbursed last 4 qtrs
11
Gross reimbursed last 4 qtrs
$66.89
Avg / prescription
$6.08
Avg / unit
$6.0809
Latest quarter Q4 2025
11Rx
Medicaid pays / ea
$6.0809
gross reimbursed
vs
NADAC / ea
$0.0220
acquisition cost
=
Spread
+$6.0589
+27540% 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 ⓘ
100% FFS
Fee-for-service · 11 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 11 units · 0.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.00.0
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 California 0.0 /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.
1 tablet68084-0753-65 105 Rx · $7
1 tablet this page68084-0753-25 11 Rx · $67
Drug total (last 4 qtrs): 116 Rx · 121 units · $74 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 68084-0752-25 · American 68084-0775-25 · American →
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.