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Chlorzoxazone 250 mg Tablet, 60-count — NDC 64980-0582-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Chlorzoxazone 250 mg Tablet, 60-count — NDC 64980-582-06 (Billing 64980-0582-06)

by Rising Pharma Holdings, Inc. · 60 TABLET in 1 BOTTLE

This is a package of 60 tablets of Chlorzoxazone 250 mg Tablet from Rising Pharma Holdings, Inc., marketed since Aug 2023 and currently FDA-listed; retail pharmacies pay about $2.52 per tablet (NADAC). It is this product's only package size.

NDC 64980-0582-06
🏷️ FDA NDC (as labeled) 64980-582-06 billing pads the product segment with a zero
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 →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64980-582-06
Product NDC 64980-582
11-digit billing NDC 64980058206
NCPDP billing unit EA — each (per item)
RxCUI 197501
UNII H0DE420U8G
Application # ANDA216925
SPL Set ID e0d10d67-9716-450b-b8a9-4e157008864e
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 2023-08-09
Route ORAL
Dosage form TABLET
Substance CHLORZOXAZONE
TE code (Orange Book) AA · RLD · RS

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

GPI-14 75100040000305
GCN Seq No 004659
GCN 17900
HICL code 001941
Ingredient (HICL) Chlorzoxazone
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 CHLORZOXAZONE 250 MG TABLET
FDB brand name Chlorzoxazone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004659
  • GCN: 17900
  • GPI-14 (Medi-Span): 75100040000305
  • HICL (First Databank): 001941
  • AHFS class code: 12:20.04.00
  • RxCUI (RxNorm): 197501
Why two NDCs? The FDA registers this code as 64980-582-06 — 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 → 64980-0582-06. 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

Label name CHLORZOXAZONE 250 MG TABLET Ingredient Chlorzoxazone
📖 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 eaPer package
Retail pharmacies payNADAC · weekly $2.521 $151.25 / 60 tablets
Medicaid paysCMS SDUD · 12 mo $13.45 $806.92 / 60 tablets
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 2025 Feb 2026 Apr 2026 Jul 2026 $3.064 $2.521
▼ Down 18% over the last 8 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
64980-0582-06 You're viewing this Main listing 60 TABLET in 1 BOTTLE 2023-08-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlorzoxazone 250 mgthis 64980-0582-06 Rising 60 tablets $2.521 AA Availability likely —
chlorzoxazone 250 mg 69499-0330-60 Solubiomix 60 tablets $2.521 AA Availability likely —
Chlorzoxazone 250 mg 72336-0225-60 Lifsa 60 tablets $2.521 AA Availability likely —
Chlorzoxazone 250 mg 87127-0801-60 Happy 60 tablets $2.521 AA Availability likely —
Chlorzoxazone 250 mg 24470-0923-10 Cintex 100 tablets — AA FDA listed —
Chlorzoxazone 250 mg 31722-0974-01 Camber 100 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
Aug 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 White
ShapeOval
Imprint21
Size12 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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 656HXR6YXN
    A combination of two additives: docusate sodium softens the medicine's texture to help it break apart, while sodium benzoate acts as a preservative to prevent spoilage and maintain shelf life.
  • 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 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • 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.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerRising Pharma Holdings, Inc.
Application holderRISING PHARMA HOLDINGS INC
FDA applicationANDA216925 (ANDA)
Labeler code64980
First marketedAug 2023
Product typeHuman Prescription Drug
Portfolio525 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 57 words ▾

INDICATIONS AND USAGE 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 64 words ▾

DOSAGE AND ADMINISTRATION Usual Adult Dosage : One tablet (250 mg) three or four times daily. Initial dosage for painful musculoskeletal conditions should be two tablets (500 mg) three or four times daily. If adequate response is not obtained with this dose, it may be increased to three tablets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.

⛔ Contraindications 12 words ▾

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

⚠️ Warnings 163 words ▾

WARNINGS 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.

🤒 Adverse Reactions 131 words ▾

ADVERSE REACTIONS After extensive clinical use of chlorzoxazone-containing products, it is apparent that the product is well tolerated and seldom produces undesirable side effects. Occasional patients may develop gastrointestinal disturbances. It is possible in rare instances that chlorzoxazone may have been associated with gastrointestinal bleeding.

Drowsiness, dizziness, lightheadedness, malaise, or overstimulation 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 REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🆘 Overdosage 167 words ▾

OVERDOSAGE 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 151 words ▾

CLINICAL PHARMACOLOGY 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 102 words ▾

HOW SUPPLIED Chlorzoxazone tablets, USP 250 mg are white to off white, oval shaped tablet, debossed with "21" on one side and plain on other side. They are supplied as follows: Bottle of 60 tablets NDC 64980-582-06 Dispense in tight container as defined in the USP. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

For more information, call Rising Pharma Holdings, Inc. at 1-844-874-7464. Manufactured by: Graviti Pharmaceuticals Pvt. Ltd.

Telangana-502307, INDIA. M.L. No.: 12/SRD/TS/2017/F/G Manufactured for: Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816 Revised: 02/2025 PIR58206-00

📋 Description 85 words ▾

DESCRIPTION Each tablet contains: Chlorzoxazone*…………… 250 mg * 5-Chloro-2-benzoxazolinone Structural Formula: Molecular Formula: C 7 H 4 ClNO 2 Molecular Weight: 169.56 Chlorzoxazone, USP is a white or practically white, 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. Inactive ingredients: anhydrous lactose, croscarmellose sodium, docusate sodium – 85% with sodium benzoate – 15%, magnesium stearate, microcrystalline cellulose, pregelatinized starch.

FDA approved dissolution specifications differ from USP. cb0d5aea-4c3c-4657-a176-0a1a27c61c20-01.jpg

⚠️ Precautions 54 words ▾

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.

📄 Package Label / Principal Display Panel 18 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 64980- 582 -06 Chlorzoxazone Tablets, USP 250 mg Rx Only 60 Tablets cb0d5aea-4c3c-4657-a176-0a1a27c61c20-02.jpg

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

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 this package alone, 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
5.2K
Units reimbursed last 4 qtrs
434.2K
Gross reimbursed last 4 qtrs
$5.84M
Avg / prescription
$1,129.55
Avg / unit
$13.4486
Latest quarter Q4 2025
1.7KRx
Medicaid pays / ea
$13.4486
gross reimbursed
vs
NADAC / ea
$2.5208
acquisition cost
=
Spread
+$10.9278
+434% 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 ⓘ
88% FFS 12% MCO
Fee-for-service · 4,524 Rx Managed care · 646 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: 1,758 units · 17.5 per 100k residents MI New York: 319,342 units · 1,632 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 35,556 units · 1,113 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 10,565 units · 84.2 per 100k residents IL Indiana: no data reported IN Ohio: 37,858 units · 321 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 12,276 units · 31.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 15,132 units · 334 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: 1,740 units · 15.8 per 100k residents 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
15.81,632
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 New York 1,632 /100k
2 Nevada 1,113 /100k
3 Kentucky 334 /100k
4 Ohio 321 /100k
5 Illinois 84.2 /100k
6 California 31.5 /100k
7 Michigan 17.5 /100k
8 Georgia 15.8 /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.

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.
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.