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Chlorzoxazone 500 mg Tablet, 60-count — NDC 80425-0315-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Chlorzoxazone 500 mg Tablet, 60-count — NDC 80425-0315-2 (Billing 80425-0315-02)

by Advanced Rx Pharmacy of Tennessee, LLC · 60 TABLET in 1 BOTTLE

This is a package of 60 tablets of Chlorzoxazone 500 mg Tablet from Advanced Rx Pharmacy of Tennessee, LLC, marketed since Apr 2023 and currently FDA-listed.

NDC 80425-0315-02
🏷️ FDA NDC (as labeled) 80425-0315-2 billing pads the package segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2693/unit — full pricing hub ↓
Product page 80425-0315-01 Also comes in: 30 tablets 80425-0315-1 90 tablets 80425-0315-3
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80425-0315-2
Product NDC 80425-0315
11-digit billing NDC 80425031502
NCPDP billing unit EA — each (per item)
RxCUI 197502
UNII H0DE420U8G
Application # ANDA089853
SPL Set ID f8ff7293-89b6-b6ee-e053-6394a90a7d39
Established class (EPC) Muscle Relaxant
Physiologic effect Centrally-mediated Muscle Relaxation
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-10
Route ORAL
Dosage form TABLET
Substance CHLORZOXAZONE
TE code (Orange Book) AA · RLD · RS
Quick answers
  • RxCUI (RxNorm): 197502
Why two NDCs? The FDA registers this code as 80425-0315-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 80425-0315-02. 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) Oxazol, thiazine, and triazine derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Chlorzoxazone is used to relieve pain and stiffness caused by muscle strains and sprains. It is used in combination with physical therapy, analgesics (such as aspirin or acetaminophen), and rest.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps relieve discomfort from sudden, painful muscle and bone conditions. It is meant to be used along with rest, physical therapy and other measures, not by itself.
  • You take it by mouth, usually three or four times a day. Your doctor may adjust the amount depending on how you respond, and it can often be lowered as you get better. Follow the d...
  • Most people tolerate it well. Some feel drowsy, dizzy, lightheaded or a bit unwell, and a few feel over-stimulated. Your urine may change color, which isn't known to be a problem.
  • Rarely, it can harm the liver. Stop the medicine and call if you have fever, rash, nausea, vomiting, unusual tiredness, upper right belly pain, dark urine or yellow skin or eyes. S...
📖 Read our full Chlorzoxazone 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.

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 $0.2693 $16.16 / 60 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
80425-0315-01 80425-0315-1 Main listing 30 TABLET in 1 BOTTLE 2023-04-10 — Active
80425-0315-02 You're viewing this 60 TABLET in 1 BOTTLE 2023-04-10 — Active
80425-0315-03 80425-0315-3 90 TABLET in 1 BOTTLE 2023-04-10 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet in 1 bottle.
How does this package differ from NDC 80425-0315-01?
Both are Chlorzoxazone 500 mg Tablet — the drug itself is identical. This page's package is the 60-count one, while NDC 80425-0315-01 is the 30 tablets package.
What NDC number is used to bill for this package of Chlorzoxazone 500 mg Tablet?
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
Chlorzoxazone 500 mg 00591-2520-01 Actavis 100 tablets $0.210 AA Availability likely —
Chlorzoxazone 500 mg 16571-0726-01 Rising 100 tablets $0.210 AA Availability likely —
Chlorzoxazone 500 mg 59651-0306-01 Aurobindo 100 tablets $0.210 — Availability likely —
Chlorzoxazone 500 mg 70954-0085-10 Novitium 100 tablets $0.210 AA Availability likely —
Chlorzoxazone 500 mg 24470-0940-10 Cintex 100 tablets — AA FDA listed —
Chlorzoxazone 500 mg 50090-0315-00 A-S 30 tablets — AA FDA listed —
Chlorzoxazone 500 mg 50090-7504-00 A-S 30 tablets — AA FDA listed —
Chlorzoxazone 500 mg 51862-0339-01 Mayne 100 tablets — AA FDA listed —
Chlorzoxazone 500 mg 55289-0633-10 PD-Rx 10 tablets — AA FDA listed —
Chlorzoxazone 500 mg 63187-0317-20 Proficient 20 tablets — AA FDA listed —
Chlorzoxazone 500 mg 63629-1586-01 Bryant 20 tablets — AA FDA listed —
Chlorzoxazone 500 mg 70518-4364-00 REMEDYREPACK 90 tablets — AA FDA listed —
Chlorzoxazone 500 mg 71205-0711-30 Proficient 30 tablets — AA FDA listed —
Chlorzoxazone 500 mg 71335-1914-01 Bryant 20 tablets — AA FDA listed —
Chlorzoxazone 500 mg 71335-2009-01 Bryant 20 tablets — AA FDA listed —
Chlorzoxazone 500 mg 71335-2433-01 Bryant 20 tablets — AA FDA listed —
Chlorzoxazone 500 mg 71335-3122-00 Bryant 10 tablets — AA FDA listed —
Chlorzoxazone 500 mgthis 80425-0315-02 Advanced 60 tablets — AA FDA listed —
Chlorzoxazone 500 mg 80425-0507-01 Advanced 30 tablets — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

What it looks like

Color orange
ShapeRound
ImprintN;500
Size13 mm
ScoringScored — splits in 2
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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerAdvanced Rx Pharmacy of Tennessee, LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA089853 (ANDA)
Labeler code80425
First marketedApr 2023
Product typeHuman Prescription Drug
Portfolio254 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 55 words ▾

Indications Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.

⏱️ Dosage and Administration 43 words ▾

Usual Adult Dosage One tablet three or four times daily. If adequate response is not obtained with this dose, it may be increased to one and one-half tablets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.

⛔ Contraindications 11 words ▾

Chlorzoxazone is contraindicated in patients with known intolerance to the drug.

⚠️ Warnings and Cautions 216 words ▾

Serious (including fatal) hepatocellular toxicity has been reported rarely in patients receiving chlorzoxazone. The mechanism is unknown but appears to be idiosyncratic and unpredictable. Factors predisposing patients to this rare event are not known.

Patients should be instructed to report early signs and/or symptoms of hepatotoxicity such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice. Chlorzoxazone should be discontinued immediately and a physician consulted if any of these signs or symptoms develop. Chlorzoxazone use should also be discontinued if a patient develops abnormal liver enzymes (e.g., AST, ALT, alkaline phosphatase and bilirubin.) The concomitant use of alcohol or other central nervous system depressants may have an additive effect.

Usage in Pregnancy The safe use of chlorzoxazone has not been established with respect to the possible adverse effects upon fetal development. Therefore, it should be used in women of childbearing potential only when, in the judgment of the physician, the potential benefits outweigh the possible risks. PRECAUTIONS Chlorzoxazone should be used with caution in patients with known allergies or with a history of allergic reactions to drugs.

If a sensitivity reaction occurs such as urticaria, redness, or itching of the skin, the drug should be stopped. If any symptoms suggestive of liver dysfunction are observed, the drug should be discontinued.

🤒 Adverse Reactions 115 words ▾

Chlorzoxazone containing products are usually well tolerated. It is possible in rare instances that chlorzoxazone may have been associated with gastrointestinal bleeding. Drowsiness, dizziness, lightheadedness, malaise, or over-stimulation may be noted by an occasional patient.

Rarely, allergic type skin rashes, petechiae, or ecchymoses may develop during treatment. Angioneurotic edema or anaphylactic reactions are extremely rare. There is no evidence that the drug will cause renal damage.

Rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of chlorzoxazone. This finding is of no known clinical significance. To report SUSPECTED ADVERSE EVENTS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800- FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

🆘 Overdosage 164 words ▾

Symptoms Initially, gastrointestinal disturbances such as nausea, vomiting, or diarrhea together with drowsiness, dizziness, lightheadedness or headache may occur. Early in the course there may be malaise or sluggishness followed by marked loss of muscle tone, making voluntary movement impossible. The deep tendon reflexes may be decreased or absent.

The sensorium remains intact, and there is no peripheral loss of sensation. Respiratory depression may occur with rapid, irregular respiration and intercostal and substernal retraction. The blood pressure is lowered, but shock has not been observed.

Treatment Gastric lavage or induction of emesis should be carried out, followed by administration of activated charcoal. Thereafter, treatment is entirely supportive. If respirations are depressed, oxygen and artificial respiration should be employed and a patent airway assured by use of an oropharyngeal airway or endotracheal tube.

Hypotension may be counteracted by use of dextran, plasma, concentrated albumin or a vasopressor agent such as norepinephrine. Cholinergic drugs or analeptic drugs are of no value and should not be used.

🧬 Clinical Pharmacology 149 words ▾

Chlorzoxazone is a centrally-acting agent for painful musculoskeletal conditions. Data available from animal experiments as well as human study indicate that chlorzoxazone acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. The clinical result is a reduction of the skeletal muscle spasm with relief of pain and increased mobility of the involved muscles.

Blood levels of chlorzoxazone can be detected in people during the first 30 minutes and peak levels may be reached, in the majority of the subjects, in about 1 to 2 hours after oral administration of chlorzoxazone. Chlorzoxazone is rapidly metabolized and is excreted in the urine, primarily in a conjugated form as the glucuronide. Less than one percent of a dose of chlorzoxazone is excreted unchanged in the urine in 24 hours.

📦 How Supplied / Storage and Handling 126 words ▾

How Supplied/Storage and Handling Chlorzoxazone tablets, USP 500 mg are available as Light orange to orange round shaped, flat hexagonal, beveled debossed with “N” on one side of break line and “500” on other side of break line and plain on other side. Bottles of 30 Tablets NDC: 80425-0315-01 Bottles of 60 Tablets NDC: 80425-0315-02 Bottles of 90 Tablets NDC: 80425-0315-03 Store at controlled room temperature 15°- 30°C (59°-86° F). Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP/NF.

Keep out of the reach of children. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Distributed by: Advanced Rx Pharmacy of Tennessee, LLC Revised: 11/2021

📋 Description 122 words ▾

Chlorzoxazone USP is a centrally acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. Its chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is: Chlorzoxazone,USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia.

Chlorzoxazone tablets contain the inactive ingredients -Lactose monohydrate USNF, Microcrystalline cellulose USNF, FD&C Yellow 6/Sunset Yellow FCF Aluminium lake, D&C Red 27/Phloxine Aluminium lake, Hypromellose USP (a) Binder solution Hypromellose USP (b), Polysarbate 80 USNF, Ethanol (96%v/v). Extragranrular Pregelatinized Starch USNF, Sodium starch glycolate USNF, Magnesium stearate USNF. FDA approved dissolution method differs from that of the USP.

Description

📄 Package Label / Principal Display Panel 6 words ▾

label 1 label 2 label 3

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Chlorzoxazone — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Chlorzoxazone. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$6.39M
Claims incl. refills
16.8K
Beneficiaries
10K
Spend / beneficiary
$639.03
Spend / claim
$380.55
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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) — 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 ✓ Available
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

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 Advanced Rx Pharmacy of Tennessee, LLC. 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 2 other package presentations of this same product, including 30 tablets (80425-0315-01), 90 tablets (80425-0315-03). 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?
Advanced Rx Pharmacy of Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 80425-0314-01 · Advanced 80425-0316-01 · Advanced →
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.