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Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated, 14-count — NDC 68071-3627-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated, 14-count — NDC 68071-3627-7 (Billing 68071-3627-07)

by NuCare Pharmaceuticals,Inc. · 14 TABLET, FILM COATED in 1 BOTTLE

This is a package of 14 tablets of Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated from NuCare Pharmaceuticals,Inc., marketed since Jul 2021 and currently FDA-listed.

NDC 68071-3627-07
🏷️ FDA NDC (as labeled) 68071-3627-7 billing pads the package segment with a zero
This package
Contains14-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.1547/unit — full pricing hub ↓
Product page 68071-3627-05 Also comes in: 15 tablets 68071-3627-5
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) 68071-3627-7
Product NDC 68071-3627
11-digit billing NDC 68071362707
RxCUI 828348
UNII 0VE05JYS2P
UPC 0368071362756
Application # ANDA071611
SPL Set ID 1ac77323-7526-a129-e063-6394a90a641b
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 2021-07-20
Route ORAL
Dosage form TABLET, FILM COATED
Substance CYCLOBENZAPRINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 828348
Why two NDCs? The FDA registers this code as 68071-3627-7 — 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 → 68071-3627-07. 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

📗 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 $2.17 / 14 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
68071-3627-05 68071-3627-5 Main listing 15 TABLET, FILM COATED in 1 BOTTLE 2024-06-13 — Active
68071-3627-07 You're viewing this 14 TABLET, FILM COATED in 1 BOTTLE 2024-06-13 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 14-count package — 14 tablet, film coated in 1 bottle.
How does this package differ from NDC 68071-3627-05?
Both are Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 14-count one, while NDC 68071-3627-05 is the 15 tablets package.
What NDC number is used to bill for this package of Cyclobenzaprine Hydrochloride 10 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 10 mg 00093-3422-01 Teva 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 00904-7401-61 Major 1 tablet $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 16571-0783-01 Rising 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine hydrochloride 10 mg 29300-0415-01 Unichem 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 50268-0191-15 AvPAK 1 tablet $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 52817-0332-00 TruPharma 1000 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 59746-0177-06 Jubilant 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 60687-0558-01 American 1 tablet $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 64980-0657-01 Rising 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 69097-0846-07 Cipla 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 70512-0872-10 SOLA 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 72603-0312-01 NORTHSTAR 100 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 72888-0014-00 Advagen 1000 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 76282-0283-10 EXELAN 1000 tablets $0.017 AB Availability likely —
Cyclobenzaprine Hydrochloride 10 mg 10702-0007-01 KVK-TECH, 100 tablets $0.022 AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 00615-8084-05 NCS 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 42291-0154-10 AvKARE 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 43547-0400-01 Solco 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 45865-0244-14 Medsource 14 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4722-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4727-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4729-01 A-S 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4730-00 A-S 90 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5711-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5712-00 A-S 3 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5713-00 A-S 90 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5772-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-6864-00 A-S 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 51655-0539-20 Northwind 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 51655-0592-20 Northwind 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 51655-0973-87 Northwind 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 53746-0541-01 Amneal 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 55154-0190-00 Cardinal 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 60760-0767-04 ST. 4 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 62332-0647-31 Alembic 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63187-0157-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63187-0812-07 Proficient 7 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63629-1209-01 Bryant 1000 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 10 mg 63629-1210-01 Bryant 500 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63629-1211-01 Bryant 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63629-9297-01 Bryant 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 65162-0541-10 Amneal 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 65862-0191-01 Aurobindo 100 tablets — — FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67046-1566-03 Coupler 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67046-1645-03 Coupler 30 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 67296-1441-01 Redpharm 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67296-1893-03 Redpharm 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67296-2084-01 Redpharm 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-2659-03 NuCare 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3150-01 NuCare 21 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3154-01 NuCare 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3404-03 NuCare 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3462-02 NuCare 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3561-04 NuCare 4 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mgthis 68071-3627-07 NuCare 14 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3973-07 NuCare 14 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3981-06 NuCare 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-4935-06 NuCare 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-4951-02 NuCare 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68788-8167-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68788-8474-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 68788-8637-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 69306-0872-03 Doc 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 70518-3415-00 REMEDYREPACK 30 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 10 mg 70518-3474-00 REMEDYREPACK 1 tablet — AB Discontinued —
Cyclobenzaprine hydrochloride 10 mg 70518-3702-00 REMEDYREPACK 60 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 10 mg 70518-3764-00 REMEDYREPACK 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71205-0065-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71205-0201-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-1266-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 71335-1962-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2110-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2492-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2666-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2678-01 Bryant 5 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2686-01 Bryant 5 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0016-30 Aphena 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0428-45 Aphena 45 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0907-45 Aphena 45 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0933-45 Aphena 45 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72162-1359-00 Bryant 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72189-0080-07 DIRECT 7 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72189-0545-15 Direct_Rx 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72789-0036-01 PD-Rx 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72789-0046-03 PD-Rx 3 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72789-0156-15 PD-Rx 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0011-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0033-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0271-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0599-02 Asclemed 2 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0830-00 Asclemed 1000 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 76420-0841-00 Asclemed 1000 tablets — AB FDA listed —
Cyclobenzaprine HCL 10 mg 80425-0018-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 80425-0019-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 80425-0498-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 80425-0547-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 82461-0716-90 Medcore 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 82804-0259-30 Proficient 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85509-1014-03 PHOENIX 30 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 85509-1415-03 PHOENIX 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85766-0003-00 Sportpharm 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85766-0041-00 Sportpharm 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 87441-0010-01 Unit 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85534-0086-00 HAWAII 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 70518-4692-00 REMEDYREPACK 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68788-4154-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67296-2306-02 Redpharm 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 00615-8665-05 NCS 15 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 85766-0274-01 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

🏛️
2021
On the market since
Jul 2021
📍
2026
Currently FDA-listed
5 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 white
ShapeRound
ImprintW53;TV
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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • 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 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 RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • 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 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 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 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.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerNuCare Pharmaceuticals,Inc.
Application holderACTAVIS LABORATORIES FL INC
FDA applicationANDA071611 (ANDA)
Labeler code68071
First marketedJul 2021
Product typeHuman Prescription Drug
Portfolio1,015 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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 129 words ▾

INDICATIONS AND USAGE Cyclobenzaprine HCl 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 HCl 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 HCl has 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 HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of cyclobenzaprine HCl for periods longer than two or three weeks is not recommended.

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

⛔ Contraindications 63 words ▾

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

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

⚠️ Warnings ~1 min read ▾

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

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

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

Cyclobenzaprine HCl 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 HCl 5 mg): Cyclobenzaprine HCl Tablets Cyclobenzaprine HCl Tablets Placebo 5 mg 10 mg 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 HCl Tablets 10 mg data are from one clinical trial. Cyclobenzaprine HCl Tablets 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 HCl 10 mg in additional controlled clinical studies, 7607 patients in the postmarketing surveillance program, and reports received since the drug was marketed. The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies. The adverse reactions reported most frequently with cyclobenzaprine HCl 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 Surveillance Program with Cyclobenzaprine HCl Tablets 10 mg Cyclobenzaprine HCl Tablets 10 mg Drowsiness 39% 16% Dry mouth 27% 7% Dizziness 11% 3% Among the less frequent adverse reactions, there was no appreciable difference in incidence in controlled clinical studies or in the surveillance program. Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.

The following adverse reactions have been reported in 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 HCl 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; dilatation of urinary tract; impoten…

🔄 Drug Interactions 136 words ▾

Drug Interactions Cyclobenzaprine HCl 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 HCl 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, PriCar, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.) † ULTRACET ® (tramadol HCl and acetaminophen tablets, PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.) _____________________________________________________________________

🤰 Pregnancy 70 words ▾

Pregnancy 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 HCl. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 20 words ▾

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

🆘 Overdosage ~2 min read ▾

OVERDOSAGE Although rare, deaths may occur from overdosage with cyclobenzaprine HCl. 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 HCl 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 HCl 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 HCl relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease. Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models.

Animal studies indicate that cyclobenzaprine does not act at the neuromuscular junction or directly on skeletal muscle. Such studies show that cyclobenzaprine acts primarily within the central nervous system at brain stem as opposed to spinal cord levels, although its action on the latter may contribute to its overall skeletal muscle relaxant activity. Evidence suggests that the net effect of cyclobenzaprine is a reduction of tonic somatic motor activity, influencing both gamma (γ) and alpha (α) motor systems.

Pharmacological studies in animals showed a similarity between the effects of cyclobenzaprine and the structurally related tricyclic antidepressants, including reserpine antagonism, norepinephrine potentiation, potent peripheral and central anticholinergic effects, and sedation. Cyclobenzaprine caused slight to moderate increase in heart rate in animals. Pharmacokinetics Estimates of mean oral bioavailability of cyclobenzaprine range from 33% to 55%.

Cyclobenzaprine exhibits linear pharmacokinetics over the dose range 2.5 mg to 10 mg, and is subject to enterohepatic circulation. It is highly bound to plasma proteins. Drug accumulates when dosed three times a day, reaching steady-state within 3-4 days at plasma concentrations about four-fold higher than after a single dose.

At steady state in healthy subjects receiving 10 mg t.i.d. (n=18), peak plasma concentration was 25.9 ng/mL (range, 12.8-46.1 ng/mL), and area under the concentration-time (AUC) curve over an 8-hour dosing interval was 177 ng.hr/mL (range, 80-319 ng.hr/mL). Cyclobenzaprine is extensively metabolized, and is excreted primarily as glucuronides via the kidney.

Cytochromes P-450 3A4, 1A2, and, to a lesser extent, 2D6, mediate N-demethylation, one of the oxidative pathways for cyclobenzaprine. Cyclobenzaprine is eliminated quite slowly, with an effective half-life of 18 hours (range 8-37 hours; n=18); plasma clearance is

0.7L/min. The plasma concentration of cyclobenzaprine is generally higher in the elderly and in patients with hepatic impairment. (See PRECAUTIONS, Use in the Elderly and PRECAUTIONS, Impaired Hepatic Function . ) Elderly In a pharmacokinetic study in elderly individuals (≥65yrs old), mean (n=10) steady-state cyclobenzaprine AUC values were approximately 1.7 fold (171.0 ng.hr/mL, range 96.1 to 255.3) higher than those seen in a group of eighteen 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 versus 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 versus 115.9 ng.hr/mL, range 36.1 to 182.9 for younger females). In light of these findings, therapy with cyclobenzaprine HCl 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 HCl 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 HCl in subjects with moderate to severe impairment is not recommended.

No significant effect on plasma levels or bioavailability of cyclobenzaprine HCl or aspirin was noted when single or multiple doses of the two drugs were administere…

📦 How Supplied / Storage and Handling 80 words ▾

HOW SUPPLIED Cyclobenzaprine Hydrochloride Tablets USP, 10 mg are round, white, unscored, film-coated tablets debossed W53 on one side and TV on the other side NDC 68071-3627-7 BOTTLES OF 14 NDC 68071-3627-5 BOTTLES OF 15 Dispense in a well-closed container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured In Czech Republic By: Teva Czech Industries, s.r.o.

Opava-Komarov, Czech Republic Manufactured By: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. A 1/2021

📋 Description 130 words ▾

DESCRIPTION Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents.

If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5 H - dibenzo[a,d]cyclohepten-5-ylidene)- N , N -dimethyl-1- propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine Hydrochloride Tablets, USP are available for oral administration as 5 mg, 7.5 mg and 10 mg tablets. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide. structural-formula

💬 Information for Patients 142 words ▾

Information for Patients Cyclobenzaprine HCl, 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 HCl 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 ).

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

Finished prescription product
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NDC identity (package / product / labeler codes) ✓ Available
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Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by NuCare Pharmaceuticals,Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 15 tablets (68071-3627-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
NuCare Pharmaceuticals,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.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68071-3626-03 · NuCare 68071-3628-09 · NuCare →
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.