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Cyclobenzaprine Hydrochloride 5 mg Tablet, Film Coated, 100-count — NDC 65862-190-01 (Billing 65862-0190-01)

by Aurobindo Pharma Limited · 100 TABLET, FILM COATED in 1 BOTTLE

This is a package of 100 tablets of Cyclobenzaprine Hydrochloride 5 mg Tablet, Film Coated from Aurobindo Pharma Limited, marketed since Sep 2008 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 65862-0190-01
🏷️ FDA NDC (as labeled) 65862-190-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1547/unit — full pricing hub ↓
Main listing for product 65862-190 · Also comes in: 500 tablets 65862-190-05 1000 tablets 65862-190-99 8000 tablets 65862-190-81
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 65862-190-01 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
65862 labeler · 190 product · 01 package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 6586219001 7
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Cyclobenzaprine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Aug 27, 2025 — Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). (Unichem Pharmaceuticals USA Inc.) · FDA recall D-0655-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65862-190-01
Product NDC 65862-190
11-digit billing NDC 65862019001
NCPDP billing unit EA — each (per item)
SPL Set ID 3b8db13a-0db8-446a-a391-f3f1573d96fb
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

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

GPI-14 75100050100303
GPI class Cyclobenzaprine HCl
GCN Seq No 047478
GCN 12805
HICL code 001950
Ingredient (HICL) Cyclobenzaprine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6H
Therapeutic class — specific (HIC3) Skeletal Muscle Relaxants
AHFS code 12:20.04.00
AHFS class Centrally Acting Skeletal Muscle Relaxnt
FDB label name CYCLOBENZAPRINE 5 MG TABLET
FDB brand name Cyclobenzaprine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 047478
  • GCN: 12805
  • GPI-14 (Medi-Span): 75100050100303
  • HICL (First Databank): 001950
  • AHFS class code: 12:20.04.00
Why two NDCs? The FDA registers this code as 65862-190-01 — 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 → 65862-0190-01. 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.

Clinical

Label name CYCLOBENZAPRINE 5 MG TABLET Ingredient Cyclobenzaprine Hcl
📖 What it is MedlinePlus · NLM

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

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

Supplement & herbal interactions

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

Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1547 $15.47 / 100 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65862-0190-01 You're viewing this Main listing 100 TABLET, FILM COATED in 1 BOTTLE 2008-09-26 — Active
65862-0190-05 65862-190-05 500 TABLET, FILM COATED in 1 BOTTLE 2008-09-26 — Active
65862-0190-99 65862-190-99 1000 TABLET, FILM COATED in 1 BOTTLE 2008-09-26 — Active
65862-0190-81 65862-190-81 8000 TABLET, FILM COATED in 1 BAG — — Active

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

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, film coated in 1 bottle.
How does this package differ from NDC 65862-0190-05?
Both are Cyclobenzaprine Hydrochloride 5 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 100-count one, while NDC 65862-0190-05 is the 500 tablets package.
What NDC number is used to bill for this package of Cyclobenzaprine Hydrochloride 5 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cyclobenzaprine Hydrochloride 5 mg 00093-3420-01 Teva 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 00904-7400-04 Major 1 tablet $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 10702-0006-01 KVK-TECH, 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 16571-0782-01 Rising 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine hydrochloride 5 mg 29300-0413-01 Unichem 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 50268-0190-15 AvPAK 1 tablet $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 52817-0330-10 TruPharma 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 59746-0211-06 Jubilant 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 64980-0655-01 Rising 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 68084-0753-25 American 1 tablet $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 69097-0845-07 Cipla 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 72603-0310-01 NORTHSTAR 100 tablets $0.022 AB Availability likely —
Cyclobenzaprine Hydrochloride 5 mg 72888-0012-00 Advagen 1000 tablets $0.022 AB Availability likely —
Cyclobenzaprine hydrochloride 5 mg 00615-8508-05 NCS 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 42708-0172-20 QPharma 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 42708-0197-20 QPharma, 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 43063-0494-01 PD-Rx 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 43547-0399-01 Solco 10 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 5 mg 50090-5756-00 A-S 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 51655-0427-26 Northwind 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 51655-0818-26 Northwind 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 53746-0540-01 Amneal 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 60429-0876-01 Golden 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 60760-0766-04 ST. 4 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 62332-0646-31 Alembic 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 63187-0094-10 Proficient 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 63629-1212-01 Bryant 500 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 5 mg 63629-1213-01 Bryant 100 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 5 mg 63629-2424-01 Bryant 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 65162-0540-10 Amneal 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mgthis 65862-0190-01 Aurobindo 100 tablets — — FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 67046-1110-03 Coupler 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 68071-2790-02 NuCare 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 68071-3475-02 NuCare 12 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 5 mg 68071-3567-02 NuCare 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 68071-3915-02 NuCare 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 68071-4655-02 NuCare 12 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 68788-8221-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 68788-8471-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 5 mg 68788-8706-02 Preferred 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 70518-2611-01 REMEDYREPACK 90 tablets — AB Discontinued —
Cyclobenzaprine hydrochloride 5 mg 70518-3251-00 REMEDYREPACK 90 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 5 mg 70518-3814-00 REMEDYREPACK 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 71205-0356-15 Proficient 15 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 71205-0678-30 Proficient 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 71335-1099-00 Bryant 100 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 5 mg 71335-1961-00 Bryant 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 71335-2156-00 Bryant 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 71335-2479-00 Bryant 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 72162-1358-01 Bryant 100 tablets — AB Discontinued —
Cyclobenzaprine Hydrochloride 5 mg 72162-1692-00 Bryant 1000 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 72189-0280-30 DirectRx 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 72189-0283-20 DirectRx 20 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 72789-0073-30 PD-Rx 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 72789-0115-10 PD-Rx 10 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 72789-0547-21 PD-Rx 21 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 76420-0030-01 Asclemed 100 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 76420-0269-01 Asclemed 1 tablet — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 76420-0828-00 Asclemed 1000 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 5 mg 76420-0839-00 Asclemed 1000 tablets — AB FDA listed —
Cyclobenzaprine HCL 5 mg 80425-0016-01 Advanced 60 tablets — AB FDA listed —
Cyclobenzaprine HCL 5 mg 80425-0017-01 Advanced 60 tablets — AB FDA listed —
Cyclobenzaprine HCL 5 mg 80425-0155-01 Advanced 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 82461-0714-90 Medcore 90 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 82868-0008-30 Northwind 30 tablets — AB FDA listed —
Cyclobenzaprine Hydrochloride 5 mg 85534-0005-00 HAWAII 30 tablets — AB FDA listed —
Cyclobenzaprine hydrochloride 5 mg 85766-0272-01 Sportpharm 100 tablets — AB FDA listed —
About this product: 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.

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.

🧪 Avoiding an ingredient? See Cyclobenzaprine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerAurobindo Pharma Limited
Labeler code65862
First marketedSep 2008
Product typeDrug For Further Processing
Portfolio1,464 products on file

More NDCs from Aurobindo Pharma Limited labeler code 65862

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full 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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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

About this NDC listing & data coverage

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by 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 500 tablets (65862-0190-05), 1000 tablets (65862-0190-99), 8000 tablets (65862-0190-81). 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.
← 65862-0189-11 · Aurobindo 65862-0191-01 · 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.