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Cyclobenzaprine Hydrochloride 5 mg Tablet, Film Coated, 30-count — NDC 70518-3814-00 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, 30-count — NDC 70518-3814-0 (Billing 70518-3814-00)

by REMEDYREPACK INC. · 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

This is a package of 30 tablets of Cyclobenzaprine Hydrochloride 5 mg Tablet, Film Coated from REMEDYREPACK INC., marketed since Aug 2023 and currently FDA-listed. It is the main listing for this product, which comes in 6 package sizes.

NDC 70518-3814-00
🏷️ FDA NDC (as labeled) 70518-3814-0 billing pads the package segment with a zero
This package
Contains30-count Pack sizes6 compare ↓
Also priced by: Part D plans $0.1547/unit — full pricing hub ↓
Main listing for product 70518-3814 · Also comes in: 10 tablets 70518-3814-2 15 tablets 70518-3814-4 20 tablets 70518-3814-5 60 tablets 70518-3814-3 90 tablets 70518-3814-1
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 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) 70518-3814-0
Product NDC 70518-3814
11-digit billing NDC 70518381400
RxCUI 828320
UNII 0VE05JYS2P
Application # ANDA208170
SPL Set ID 5d536e88-62be-45bd-bd09-0efc53fe12b9
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 2023-08-01
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

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
  • HICL (First Databank): 001950
  • AHFS class code: 12:20.04.00
  • RxCUI (RxNorm): 828320
Why two NDCs? The FDA registers this code as 70518-3814-0 — 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 → 70518-3814-00. 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 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 · Q2 2026 $0.1547 $4.64 / 30 tablets
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 Marketing startMarketing endStatus
70518-3814-00 You're viewing this Main listing 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2023-08-01 — Active
70518-3814-01 70518-3814-1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2023-08-02 — Active
70518-3814-02 70518-3814-2 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2023-08-18 — Active
70518-3814-03 70518-3814-3 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2023-10-07 — Active
70518-3814-04 70518-3814-4 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2023-10-10 — Discontinued by firm
70518-3814-05 70518-3814-5 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2023-12-23 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet, film coated in 1 bottle, plastic.
How does this package differ from NDC 70518-3814-02?
Both are Cyclobenzaprine Hydrochloride 5 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 30-count one, while NDC 70518-3814-02 is the 10 tablets package.
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.

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 mg 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 mgthis 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

🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 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 yellow
ShapeRound
Imprint020
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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • 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 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

LabelerREMEDYREPACK INC.
Application holderRUBICON RESEARCH LTD
FDA applicationANDA208170 (ANDA)
Labeler code70518
First marketedAug 2023
Product typeHuman Prescription Drug
Portfolio1,527 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 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 133 words ▾

INDICATIONS AND USAGE Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 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 81 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 2 or 3 weeks is not recommended (see INDICATIONS AND USAGE) .

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

⛔ Contraindications 63 words ▾

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

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

⚠️ Warnings ~1 min read ▾

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

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

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

Cyclobenzaprine 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 two double-blind*, placebo-controlled 5 mg studies (incidence of > 3% on cyclobenzaprine hydrochloride 5 mg): Cyclobenzaprine Hydrochloride 5 mg Cyclobenzaprine Hydrochloride 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% *Note: Cyclobenzaprine hydrochloride 10 mg data are from one clinical trial. Cyclobenzaprine hydrochloride 5 mg and placebo data are from two studies. 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 10 mg in additional controlled clinical studies, 7,607 patients in the postmarketing surveillance program, and reports received since the drug was marketed. The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies. The adverse reactions reported most frequently with cyclobenzaprine 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: Clinical Studies with Cyclobenzaprine hydrochloride 10 mg Surveillance Program with Cyclobenzaprine hydrochloride 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 postmarketing 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 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. Respiratory: Dyspnea.

Skin: Photosensitization; alopecia. Urogenital: Impaired urination; dilata… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage ~2 min read ▾

OVERDOSAGE Although rare, deaths may occur from overdosage with cyclobenzaprine. 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 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 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 3 times a day, reaching steady-state within 3 to 4 days at plasma concentrations about 4-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 to 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 to 319 ng·hr/mL). Cyclobenzaprine is extensively metabolized, and is excreted primarily as glucuronides via the kidney.

Cytochromes P450 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 to 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 ng·hr/mL, range 96.1 to 255.3) higher than those seen in a group of 18 younger adults (101.4 ng·hr/mL, range 36.1 to 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 to 255.3 vs. 83.2 ng·hr/mL, range 41.1 to 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 to 196.3 vs. 115.9 ng·hr/mL, range 36.1 to 182.9 for younger females).

In light of these findings, therapy with cyclobenzaprine in the elderly should be initiated with a 5 mg dose and titrated slowly upward. Hepatic Impairment In a pharmacokinetic study of 16 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 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 in subjects with moderate to severe impairment is not recommended. No significant effect on plasma levels or bioavailability of cyclobenzaprine or aspirin was noted when single or multiple doses of the two drugs were administered concomitantly… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 162 words ▾

HOW SUPPLIED Cyclobenzaprine Hydrochloride Tablets, USP are available containing 5 mg, 7.5 mg or 10 mg of cyclobenzaprine hydrochloride, USP. The 5 mg tablets are butter scotch yellow film-coated, round tablets debossed with 020 on one side and plain on other side. They are available as follows: NDC: 70518-3814-00 NDC: 70518-3814-01 NDC: 70518-3814-02 NDC: 70518-3814-03 NDC: 70518-3814-04 NDC: 70518-3814-05 NDC: 70518-3814-06 NDC: 70518-3814-07 NDC: 70518-3814-08 PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 10 in 1 BOTTLE PLASTIC PACKAGING: 60 in 1 BOTTLE PLASTIC PACKAGING: 15 in 1 BOTTLE PLASTIC PACKAGING: 20 in 1 BOTTLE PLASTIC PACKAGING: 14 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 60 in 1 BOTTLE PLASTIC Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

📋 Description 192 words ▾

DESCRIPTION Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular 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, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane.

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: Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide.

The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake. Image

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Because of its atropine-like action, cyclobenzaprine 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: Hepatic Impairment ). These patients are generally more susceptible to drugs with potentially sedating effects, including cyclobenzaprine.

Cyclobenzaprine hydrochloride 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 in subjects with moderate to severe impairment is not recommended. Information for Patients Cyclobenzaprine, 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 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 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 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. Carcinogenesis, Mutagenesis, Impairment of Fertility In rats treated with cyclobenzaprine 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 Teratogenic Effects. Pregnancy Category B Reproduction studies have been performed in rats, mice and rabbits at doses up to 20 times the human dose, and have revealed no evidence of impaired fertility or harm to the fetus due to cyclobenzaprine. There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not alwa… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 53 words ▾

DRUG ABUSE AND DEPENDENCE Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when cyclobenzaprine is 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 150 words ▾

DRUG: CYCLOBENZAPRINE HYDROCHLORIDE GENERIC: cyclobenzaprine hydrochloride DOSAGE: TABLET, FILM COATED ADMINSTRATION: ORAL NDC: 70518-3814-0 NDC: 70518-3814-1 NDC: 70518-3814-2 NDC: 70518-3814-3 NDC: 70518-3814-4 NDC: 70518-3814-5 NDC: 70518-3814-6 NDC: 70518-3814-7 NDC: 70518-3814-8 COLOR: yellow SHAPE: ROUND SCORE: No score SIZE: 8 mm IMPRINT: 020 PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 10 in 1 BOTTLE PLASTIC PACKAGING: 60 in 1 BOTTLE PLASTIC PACKAGING: 15 in 1 BOTTLE PLASTIC PACKAGING: 20 in 1 BOTTLE PLASTIC PACKAGING: 14 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 60 in 1 BOTTLE PLASTIC ACTIVE INGREDIENT(S): CYCLOBENZAPRINE HYDROCHLORIDE 5mg in 1 INACTIVE INGREDIENT(S): ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE (15 MPA.S AT 5%) D&C YELLOW NO.

10 FD&C BLUE NO. 2 FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POLYETHYLENE GLYCOL 400 POLYSORBATE 80 SILICON DIOXIDE STARCH, CORN TITANIUM DIOXIDE MM1 MM2 MM3 MM4 MM5 MM6 MM7 MM8 Remedy_Label

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

About this NDC listing & data coverage

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Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 10 tablets (70518-3814-02), 15 tablets (70518-3814-04), 20 tablets (70518-3814-05). Each has its own NDC and its own page — see the package list near the top of this page.
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REMEDYREPACK INC. 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.
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← 70518-3809-00 · REMEDYREPACK 70518-3815-00 · REMEDYREPACK →
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.