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Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated, 500-count — NDC 65862-0191-05 package photo

Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated, 500-count

by Aurobindo Pharma Limited · 500 TABLET, FILM COATED in 1 BOTTLE (65862-191-05)
NDC 65862-0191-05
🏷️ FDA NDC (as labeled) 65862-191-05 billing pads the product segment with a zero
This package
Contains500-count Cost per ea$0.0170 NADAC Per package$8.50 / 500 tablets Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.1386/unit · Part D plans $0.1547/unit — full pricing hub ↓
Also comes in: 100 tablets 65862-0191-01 1000 tablets 65862-0191-99 8000 tablets 65862-0191-81
On market Non-controlled
🗂️ Data synced Sep 17, 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

FDA NDC (as labeled) 65862-191-05
Product NDC 65862-191
11-digit billing NDC 65862019105
NCPDP billing unit EA — each (per item)
SPL Set ID 1154688c-1383-442b-a3a5-ec01e038795c
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-09-26
Dosage form TABLET, FILM COATED
Substance CYCLOBENZAPRINE HYDROCHLORIDE
GPI-14 75100050100305
GPI class Cyclobenzaprine HCl
GCN Seq No 004681
GCN 18020
HICL code 001950
Ingredient (HICL) Cyclobenzaprine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6H
Therapeutic class — specific (HIC3) Skeletal Muscle Relaxants
AHFS code 12:20.04.00
AHFS class Centrally Acting Skeletal Muscle Relaxnt
FDB label name CYCLOBENZAPRINE 10 MG TABLET
FDB brand name Cyclobenzaprine Hcl
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 65862-191-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65862-0191-05. 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.

🏭 Manufacturer & labeler

LabelerAurobindo Pharma Limited
Labeler code65862
First marketedSep 2008
Product typeDrug For Further Processing
Portfolio1,452 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CYCLOBENZAPRINE 10 MG TABLET Ingredient Cyclobenzaprine Hcl
📗 Our plain-language guide HelloPharmacist
  • It's a muscle relaxant prescribed to help ease muscle spasms, pain, and stiffness from acute musculoskeletal injuries — like a back strain or a pulled muscle. It's meant to be used...
  • What is cyclobenzaprine actually used for?
  • Yes, drowsiness is one of the most common side effects — it's real and can be significant. You should not drive, operate heavy machinery, or do anything that requires sharp focus u...
  • Will this make me really drowsy? Can I drive?
📖 Read our full Cyclobenzaprine guide →

Supplement & herbal interactions

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

💊 What it looks like

Color Yellow
ShapePENTAGON (5 sided)
ImprintD;32
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 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 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.017 $8.50 / 500 tablets
Medicaid paysCMS SDUD · 12 mo $0.1386 $69.30 / 500 tablets
Medicare drug plans payPart D · Q2 2026 $0.1547 $77.35 / 500 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.027 $0.017
▼ Down 30% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 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 mgthis 65862-0191-05 Aurobindo 500 tablets $0.017 — 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 +27%
Cyclobenzaprine Hydrochloride 10 mg 00615-8084-05 NCS 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 42291-0154-10 AvKARE 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 43547-0400-01 Solco 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 45865-0244-14 Medsource 14 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4722-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4727-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4729-01 A-S 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-4730-00 A-S 90 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5711-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5712-00 A-S 3 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5713-00 A-S 90 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 50090-5772-00 A-S 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 50090-6864-00 A-S 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 51655-0539-20 Northwind 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 51655-0592-20 Northwind 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 51655-0973-87 Northwind 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 53746-0541-01 Amneal 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 55154-0190-00 Cardinal 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 60760-0767-04 ST. 4 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 62332-0647-31 Alembic 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63187-0157-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63187-0812-07 Proficient 7 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63629-1209-01 Bryant 1000 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 10 mg 63629-1210-01 Bryant 500 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63629-1211-01 Bryant 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 63629-9297-01 Bryant 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 65162-0541-10 Amneal 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67046-1566-03 Coupler 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67046-1645-03 Coupler 30 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 67296-1441-01 Redpharm 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67296-1893-03 Redpharm 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 67296-2084-01 Redpharm 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-2659-03 NuCare 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3150-01 NuCare 21 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3154-01 NuCare 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3404-03 NuCare 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3462-02 NuCare 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3561-04 NuCare 4 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3627-05 NuCare 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3973-07 NuCare 14 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-3981-06 NuCare 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-4935-06 NuCare 6 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68071-4951-02 NuCare 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68788-8167-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 68788-8474-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 68788-8637-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 69306-0872-03 Doc 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 70518-3415-00 REMEDYREPACK 30 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 10 mg 70518-3474-00 REMEDYREPACK 1 tablet — AB Discontinued —
Cyclobenzaprine hydrochloride 10 mg 70518-3702-00 REMEDYREPACK 60 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 10 mg 70518-3764-00 REMEDYREPACK 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71205-0065-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71205-0201-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-1266-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 71335-1962-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2110-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2492-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2666-00 Bryant 40 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2678-01 Bryant 5 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71335-2686-01 Bryant 5 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0016-30 Aphena 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0428-45 Aphena 45 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0907-45 Aphena 45 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 71610-0933-45 Aphena 45 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72162-1359-00 Bryant 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72189-0080-07 DIRECT 7 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72189-0545-15 Direct_Rx 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72789-0036-01 PD-Rx 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72789-0046-03 PD-Rx 3 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 72789-0156-15 PD-Rx 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0011-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0033-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0271-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0599-02 Asclemed 2 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 76420-0830-00 Asclemed 1000 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 76420-0841-00 Asclemed 1000 tablets — AB FDA listed —
Cyclobenzaprine HCL 10 mg 80425-0018-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 80425-0019-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 80425-0498-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 80425-0547-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 82461-0716-90 Medcore 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 82804-0259-30 Proficient 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85509-1014-03 PHOENIX 30 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 10 mg 85509-1415-03 PHOENIX 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85766-0003-00 Sportpharm 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 85766-0041-00 Sportpharm 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 10 mg 87441-0010-01 Unit 30 tablets — AB FDA listed —
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: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2008
On the market since
Sep 2008
📍
2026
Currently FDA-listed
18 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 65862-0191-05, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
309.1K
Units reimbursed last 4 qtrs
13.7M
Gross reimbursed last 4 qtrs
$1.89M
Avg / prescription
$6.12
Avg / unit
$0.1386
Latest quarter Q4 2025
69.3KRx
Medicaid pays / ea
$0.1386
gross reimbursed
vs
NADAC / ea
$0.0170
acquisition cost
=
Spread
+$0.1216
+715% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
25% FFS 75% MCO
Fee-for-service · 77,550 Rx Managed care · 231,595 Rx
State Medicaid map
Alaska: 9,330 units · 1,273 per 100k residents AK Maine: 5,899 units · 423 per 100k residents ME Washington: 86,358 units · 1,105 per 100k residents WA Idaho: 11,101 units · 565 per 100k residents ID Montana: 4,069 units · 359 per 100k residents MT North Dakota: 27,866 units · 3,559 per 100k residents ND Minnesota: 133,734 units · 2,331 per 100k residents MN Wisconsin: 200,640 units · 3,395 per 100k residents WI Michigan: 775,259 units · 7,724 per 100k residents MI New York: 1,752,051 units · 8,952 per 100k residents NY Vermont: 1,604 units · 248 per 100k residents VT New Hampshire: 3,687 units · 263 per 100k residents NH Oregon: 59,338 units · 1,402 per 100k residents OR Nevada: 24,735 units · 774 per 100k residents NV Wyoming: 2,999 units · 514 per 100k residents WY South Dakota: no data reported SD Iowa: 107,208 units · 3,343 per 100k residents IA Illinois: 966,410 units · 7,701 per 100k residents IL Indiana: 2,191,821 units · 31,941 per 100k residents IN Ohio: 1,769,804 units · 15,017 per 100k residents OH Pennsylvania: 2,116,514 units · 16,330 per 100k residents PA New Jersey: 955,244 units · 10,282 per 100k residents NJ Massachusetts: 39,836 units · 569 per 100k residents MA California: 218,342 units · 560 per 100k residents CA Utah: 16,343 units · 478 per 100k residents UT Colorado: 129,031 units · 2,195 per 100k residents CO Nebraska: 87,221 units · 4,410 per 100k residents NE Missouri: 227,916 units · 3,678 per 100k residents MO Kentucky: 132,264 units · 2,922 per 100k residents KY West Virginia: 351,060 units · 19,834 per 100k residents WV Virginia: 171,982 units · 1,973 per 100k residents VA Maryland: 589,552 units · 9,540 per 100k residents MD Connecticut: 20,235 units · 559 per 100k residents CT Rhode Island: no data reported RI Arizona: 17,514 units · 236 per 100k residents AZ New Mexico: 6,944 units · 328 per 100k residents NM Kansas: 28,784 units · 979 per 100k residents KS Arkansas: 30,074 units · 981 per 100k residents AR Tennessee: 30,174 units · 423 per 100k residents TN North Carolina: 46,090 units · 425 per 100k residents NC South Carolina: 11,015 units · 205 per 100k residents SC Delaware: 82,429 units · 7,995 per 100k residents DE Oklahoma: 81,282 units · 2,005 per 100k residents OK Louisiana: 40,187 units · 879 per 100k residents LA Mississippi: 7,044 units · 240 per 100k residents MS Alabama: no data reported AL Georgia: 23,206 units · 210 per 100k residents GA D.C.: 19,495 units · 2,871 per 100k residents DC Hawaii: 7,361 units · 513 per 100k residents HI Texas: 34,479 units · 113 per 100k residents TX Florida: 3,662 units · 16.2 per 100k residents FL
Units reimbursed · per 100k residents
16.231,941
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Indiana 31,941 /100k
2 West Virginia 19,834 /100k
3 Pennsylvania 16,330 /100k
4 Ohio 15,017 /100k
5 New Jersey 10,282 /100k
6 Maryland 9,540 /100k
7 New York 8,952 /100k
8 Delaware 7,995 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
500 tablets this page65862-0191-05 310,887 Rx · $1,950,774
100 tablets65862-0191-01 No Medicaid data
1000 tablets65862-0191-99 No Medicaid data
8000 tablets65862-0191-81 No Medicaid data
Drug total (last 4 qtrs): 310,887 Rx · 13,766,499 units · $1,950,774 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Cyclobenzaprine hydrochloride — the ingredient across all brands.

Top reported reactions

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

Age at onset

Neonate1
Infant1
Child4
Adolescent10
Adult1,568
Elderly781

Reporter sex

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

Serious outcomes

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

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
65862-0191-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-191-01) — — 2008-09-26 Active
65862-0191-05 You're viewing this 500 TABLET, FILM COATED in 1 BOTTLE (65862-191-05) $0.0170 / ea $8.48 2008-09-26 Active
65862-0191-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-191-99) — — 2008-09-26 Active
65862-0191-81 8000 TABLET, FILM COATED in 1 BAG (65862-191-81) — — — Active

You're viewing one of 4 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 65862-0191-05?
NDC 65862-0191-05 is a 500-count package — 500 tablet, film coated in 1 bottle.
What is the difference between NDC 65862-0191-05 and NDC 65862-0191-01?
Both are Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated — the drug itself is identical. NDC 65862-0191-05 is the 500-count package, while NDC 65862-0191-01 is the 100 tablets package.
What NDC number is used to bill for this package of Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated?
Bill NDC 65862-0191-05 — the 11-digit billing format is 65862019105. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Aurobindo Pharma Limited supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 65862-191-05, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 65862-0191-05, written without dashes as 65862019105. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 65862-0191-05, the first segment (65862) is the labeler code FDA assigned to Aurobindo Pharma Limited; the middle segment (0191) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Aurobindo Pharma Limited. 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 3 other package presentations of this same product, including 100 tablets (65862-0191-01), 1000 tablets (65862-0191-99), 8000 tablets (65862-0191-81). 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?
Aurobindo Pharma Limited 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.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 135 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, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.

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

⏱️ Dosage and Administration 82 words ▾

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

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

⛔ Contraindications 63 words ▾

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

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

⚠️ Warnings ~1 min read ▾

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

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

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

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

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Incidence of most common adverse reactions in the 2 double-blind 3 , 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% 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, 7607 patients in the postmarketing surveillance program, and reports received since the drug was marketed. The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies. The adverse reactions reported most frequently with cyclobenzaprine hydrochloride were drowsiness, dry mouth and dizziness.

The incidence of these common adverse reactions was lower in the surveillance program than in the controlled clinical studies: 3 Note: Cyclobenzaprine hydrochloride 10 mg data are from one clinical trial. Cyclobenzaprine hydrochloride 5 mg and placebo data are from two 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 post-marketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg tablet: Body as a Whole: Syncope; malaise. Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension.

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

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

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

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

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

Respiratory: Dyspnea. Skin: Photosensitization; alopecia. Urogenital: Imp…

🔄 Drug Interactions 132 words ▾

Drug Interactions Cyclobenzaprine may have life-threatening interactions with MAO inhibitors (see CONTRAINDICATIONS ). Postmarketing cases of serotonin syndrome have been reported during combined use of cyclobenzaprine hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. If concomitant treatment with cyclobenzaprine hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see WARNINGS ).

Cyclobenzaprine hydrochloride 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.

2 2 ULTRAM ® (tramadol HCl tablets, PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.) ULTRACET ® (tramadol HCl and acetaminophen tablets, PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.)

🤰 Pregnancy 73 words ▾

Pregnancy 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 hydrochloride. 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 hydrochloride in pediatric patients below 15 years of age have not been established.

🧓 Geriatric Use 80 words ▾

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

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

🆘 Overdosage ~2 min read ▾

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

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

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

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

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

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

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

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

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

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

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

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease. Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models.

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

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

Cyclobenzaprine exhibits linear pharmacokinetics over the dose range 2.5 mg to 10 mg, and is subject to enterohepatic circulation. It is highly bound to plasma proteins. Drug accumulates when dosed three times a day, reaching steady-state within 3 to 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 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 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 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 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 hydrochloride in the elderly should be initiated with a 5 mg dose and titrated slowly upward.

Hepatic Impairment In a pharmacokinetic study of sixteen subjects with hepatic impairment (15 mild, 1 moderate per Child-Pugh score), both AUC and C max were approximately double the values seen in the healthy control group. Based on the findings, cyclobenzaprine hydrochloride should be used with caution in subjects with mild hepatic impairment starting with the 5 mg dose and titrating slowly upward. Due to the lack of data in subjects with more severe hepatic insufficiency, the use of cyclobenzaprine hydrochloride in subjects with moderate to severe impairment is not recommended.

No significant effect on plasma levels or bioavailability of cyclobenzaprine hydrochloride or aspirin was noted whe…

📦 How Supplied / Storage and Handling 131 words ▾

HOW SUPPLIED Cyclobenzaprine Hydrochloride Tablets USP, 5 mg are yellow-orange, biconvex, 5-sided D-shaped film-coated tablets, debossed with ‘D’ and ‘87’ on one side and plain on other side. Bottles of 100 NDC 65862-190-01 Bottles of 500 NDC 65862-190-05 Bottles of 1,000 NDC 65862-190-99 Cyclobenzaprine Hydrochloride Tablets USP, 10 mg are butterscotch yellow, biconvex, 5-sided D-shaped film-coated tablets, debossed with ‘D’ and ‘32’ on one side and plain on other side. Bottles of 100 NDC 65862-191-01 Bottles of 500 NDC 65862-191-05 Bottles of 1,000 NDC 65862-191-99 STORAGE Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 032, India Revised: 09/2021

📋 Description 165 words ▾

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

If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-( 5H -dibenzo[ a , d ] cyclohepten-5-ylidene)- N, N -dimethyl-1-propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine hydrochloride is supplied as 5 mg or 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch (maize) and titanium dioxide.

In addition 5 mg also contains D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide. FDA approved dissolution test specifications differ from USP. Chemical Structure

💬 Information for Patients 142 words ▾

Information for Patients Cyclobenzaprine hydrochloride, 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 see PRECAUTIONS , Drug Interactions ).

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65862-0190-01 · Aurobindo 65862-0192-01 · Aurobindo →
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.