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Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated — NDC 50268-0191-15 package photo

Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated

by AvPAK · 50 BLISTER PACK in 1 BOX (50268-191-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-191-11)
NDC 50268-0191-15
🏷️ FDA NDC (as labeled) 50268-191-15 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 50268-191-15
Product NDC 50268-191
11-digit billing NDC 50268019115
NCPDP billing unit EA — each (per item)
RxCUI 828348
UNII 0VE05JYS2P
Application # ANDA090478
SPL Set ID e530fd1e-06fd-0432-e053-2995a90adf5f
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 2022-08-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance CYCLOBENZAPRINE HYDROCHLORIDE
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
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 50268-191-15 — 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 → 50268-0191-15. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Muscle Relaxant class.

Pharmacologic class Muscle Relaxant
Drug family (ATC) Other centrally acting agents
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAvPAK
Application holderINVAGEN PHARMACEUTICALS INC
FDA applicationANDA090478 (ANDA)
Labeler code50268
First marketedAug 2022
Product typeHuman Prescription Drug
Portfolio346 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
📖 What it is MedlinePlus · NLM

Cyclobenzaprine is used to treat muscle spasms. Cyclobenzaprine is in a class of medications called skeletal muscle relaxants. It works by acting in the brain and nervous system to allow the muscles to relax.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's a muscle relaxant prescribed to help ease muscle spasms, pain, and stiffness from acute musculoskeletal injuries — like a back strain or a pulled muscle. It's meant to be used...
  • What is cyclobenzaprine actually used for?
  • Yes, drowsiness is one of the most common side effects — it's real and can be significant. You should not drive, operate heavy machinery, or do anything that requires sharp focus u...
  • Will this make me really drowsy? Can I drive?
📖 Read our full Cyclobenzaprine guide →
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
ShapeRound
ImprintIG;283
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 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 0VUT3PMY82
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
  • 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 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 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 $0.85 / 50 tablet
Medicaid paysCMS SDUD · 12 mo $18.77 $938.39 / 50 tablet
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.023 $0.017
▼ Down 24% over the last 12 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 mgthis 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 +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 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 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 —
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

🏛️
2022
On the market since
Aug 2022
📍
2026
Currently FDA-listed
4 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.

🗺️ 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 50268-0191-15, 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
604
Units reimbursed last 4 qtrs
618
Gross reimbursed last 4 qtrs
$11.6K
Avg / prescription
$19.20
Avg / unit
$18.7677
Latest quarter Q4 2025
168Rx
Medicaid pays / ea
$18.7677
gross reimbursed
vs
NADAC / ea
$0.0170
acquisition cost
=
Spread
+$18.7507
+110298% 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 ⓘ
53% FFS 47% MCO
Fee-for-service · 319 Rx Managed care · 285 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 227 units · 0.6 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 234 units · 3.8 per 100k residents MO Kentucky: 157 units · 3.5 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.63.8
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 Missouri 3.8 /100k
2 Kentucky 3.5 /100k
3 California 0.6 /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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50268-0191-15 You're viewing this 50 BLISTER PACK in 1 BOX (50268-191-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-191-11) 2022-08-01 Active

📄 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 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 131 words ▾

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

(see INDICATIONS AND USAGE ). Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS , Impaired Hepatic Function , and 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 tablets, 5 mg): 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 tablets, 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: ‡ Note: Cyclobenzaprine HCl tablets, 10 mg data are from one clinical trial.

Cyclobenzaprine HCl tablets, 5 mg and placebo data are from two studies . 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.

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; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea. IMAGE IMAGE

🔄 Drug Interactions 126 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 hydrochloride tablets, Ortho-McNeil Pharmaceutical) † ULTRACET ® (tramadol hydrochloride and acetaminophen tablets, Ortho-McNeil Pharmaceutical)

🤰 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 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 LD50 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 pCO2<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 96.1-255.3) higher than those seen in a group of eighteen younger adults (101.4 ng.hr/mL, range 36.1-182.9) from another study.

Elderly male subjects had the highest observed mean increase, approximately 2.4 fold (198.3 ng.hr/mL, range 155.6-255.3 versus 83.2 ng.hr/mL, range 41.1-142.5 for younger males) while levels in elderly females were increased to a much lesser extent, approximately 1.2 fold (143.8 ng.hr/mL, range 96.1-196.3 versus 115.9 ng.hr/mL, range 36.1-182.9 for younger females). In light of these findings, therapy with cyclobenzaprine 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 administered concomitantly.

Co…

📦 How Supplied / Storage and Handling 84 words ▾

HOW SUPPLIED Cyclobenzaprine hydrochloride tablets USP are available in 5 mg and 10 mg dosage strengths. The 5 mg tablets are beige colored, film coated, round, biconvex tablets debossed with 'IG' on one side and "282" on other. The 10 mg tablets are yellow colored, film coated, round, biconvex tablets debossed with 'IG' on one side and "283" on other.

These are supplied as follows: NDC 50268-191-15 (10 tablets per card, 5 cards per carton). Dispensed in Unit Dose Package. For Institutional Use Only.

📦 Storage and Handling 30 words ▾

STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 05/20 AV Rev. 07/22 (P) AvPAK

📋 Description 201 words ▾

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

If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP 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 HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration.

Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).

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💬 Information for Patients 152 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 selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (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 ↗
← 50268-0190-15 · AvPAK 50268-0192-15 · AvPAK →
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.