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Chlorzoxazone 500 mg Tablet, 100-count — NDC 70954-0085-10 package photo

Chlorzoxazone 500 mg Tablet, 100-count

by Novitium Pharma LLC · 100 TABLET in 1 BOTTLE (70954-085-10)
NDC 70954-0085-10
🏷️ FDA NDC (as labeled) 70954-085-10 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.2117 NADAC Per package$21.17 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3163/unit · Part D plans $0.2693/unit — full pricing hub ↓
Also comes in: 500 tablets 70954-0085-20
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) 70954-085-10
Product NDC 70954-085
11-digit billing NDC 70954008510
NCPDP billing unit EA — each (per item)
RxCUI 197502
UNII H0DE420U8G
UPC 0370954085201, 0370954085102
Application # ANDA212254
SPL Set ID 69c87a85-4b6b-405b-9fa5-4c91c0f90c70
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 2019-09-12
Route ORAL
Dosage form TABLET
Substance CHLORZOXAZONE
GPI-14 75100040000310
GPI class Chlorzoxazone
GCN Seq No 004660
GCN 17901
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 500 MG TABLET
FDB brand name Chlorzoxazone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 70954-085-10 — 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 → 70954-0085-10. 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.

🏭 Manufacturer & labeler

LabelerNovitium Pharma LLC
Application holderNOVITIUM PHARMA LLC
FDA applicationANDA212254 (ANDA)
Labeler code70954
First marketedSep 2019
Product typeHuman Prescription Drug
Portfolio17 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 CHLORZOXAZONE 500 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
  • Chlorzoxazone is a muscle relaxant used to help with short-term muscle pain and spasms — the kind that comes on suddenly from an injury or strain. It's meant to be used together wi...
  • Yes, drowsiness and dizziness are real possibilities with chlorzoxazone. Until you know how it affects you, it's best to avoid driving or operating machinery. Alcohol makes the dro...
  • Will this make me drowsy? Is it safe to drive?
  • This is actually a known and harmless side effect. Chlorzoxazone breaks down into a substance that can temporarily color your urine orange or reddish-brown. It has no known clinica...
📖 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.

💊 What it looks like

Color White
ShapeCapsule
ImprintN085
Size17 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.

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

  • 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 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 F05Q2T2JA0
    Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
  • 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 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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.

7 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 $0.212 $21.17 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.3163 $31.63 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.2693 $26.93 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.271 $0.212
▼ Down 21% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlorzoxazone 500 mg 00591-2520-01 Actavis 100 tablets $0.212 AA Availability likely —
Chlorzoxazone 500 mg 16571-0726-01 Rising 100 tablets $0.212 AB Availability likely —
Chlorzoxazone 500 mg 59651-0306-01 Aurobindo 100 tablets $0.212 — Availability likely —
Chlorzoxazone 500 mgthis 70954-0085-10 Novitium 100 tablets $0.212 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 — AB FDA listed —
Chlorzoxazone 500 mg 51862-0339-01 Mayne 100 tablets — AB 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 — AB FDA listed —
Chlorzoxazone 500 mg 71205-0711-30 Proficient 30 tablets — AB FDA listed —
Chlorzoxazone 500 mg 71335-1914-01 Bryant 20 tablets — AA FDA listed —
Chlorzoxazone 500 mg 71335-2009-01 Bryant 20 tablets — AB FDA listed —
Chlorzoxazone 500 mg 71335-2433-01 Bryant 20 tablets — AB FDA listed —
Chlorzoxazone 500 mg 71335-3122-00 Bryant 10 tablets — AA FDA listed —
Chlorzoxazone 500 mg 80425-0315-01 Advanced 30 tablets — AB FDA listed —
Chlorzoxazone 500 mg 80425-0507-01 Advanced 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

🏛️
2019
On the market since
Sep 2019
📍
2026
Currently FDA-listed
7 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 70954-0085-10, 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
6.3K
Units reimbursed last 4 qtrs
447.9K
Gross reimbursed last 4 qtrs
$141.7K
Avg / prescription
$22.34
Avg / unit
$0.3163
Latest quarter Q4 2025
1.3KRx
Medicaid pays / ea
$0.3163
gross reimbursed
vs
NADAC / ea
$0.2117
acquisition cost
=
Spread
+$0.1046
+49% 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 ⓘ
26% FFS 74% MCO
Fee-for-service · 1,641 Rx Managed care · 4,701 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: 3,537 units · 61.7 per 100k residents MN Wisconsin: 11,513 units · 195 per 100k residents WI Michigan: 14,611 units · 146 per 100k residents MI New York: 29,301 units · 150 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 5,788 units · 137 per 100k residents OR Nevada: 35,471 units · 1,111 per 100k residents NV Wyoming: no data reported WY South Dakota: 868 units · 94.5 per 100k residents SD Iowa: no data reported IA Illinois: 17,472 units · 139 per 100k residents IL Indiana: 14,262 units · 208 per 100k residents IN Ohio: 58,093 units · 493 per 100k residents OH Pennsylvania: 4,185 units · 32.3 per 100k residents PA New Jersey: 13,208 units · 142 per 100k residents NJ Massachusetts: 2,470 units · 35.3 per 100k residents MA California: 12,732 units · 32.7 per 100k residents CA Utah: 6,190 units · 181 per 100k residents UT Colorado: 1,230 units · 20.9 per 100k residents CO Nebraska: 6,787 units · 343 per 100k residents NE Missouri: 8,661 units · 140 per 100k residents MO Kentucky: 33,289 units · 736 per 100k residents KY West Virginia: 6,986 units · 395 per 100k residents WV Virginia: 11,667 units · 134 per 100k residents VA Maryland: 14,135 units · 229 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 23,709 units · 319 per 100k residents AZ New Mexico: 9,017 units · 427 per 100k residents NM Kansas: no data reported KS Arkansas: 8,127 units · 265 per 100k residents AR Tennessee: 12,080 units · 170 per 100k residents TN North Carolina: 7,823 units · 72.2 per 100k residents NC South Carolina: 4,505 units · 83.8 per 100k residents SC Delaware: 3,210 units · 311 per 100k residents DE Oklahoma: 20,362 units · 502 per 100k residents OK Louisiana: 16,651 units · 364 per 100k residents LA Mississippi: no data reported MS Alabama: 677 units · 13.3 per 100k residents AL Georgia: 6,549 units · 59.4 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 11,992 units · 39.3 per 100k residents TX Florida: 10,750 units · 47.5 per 100k residents FL
Units reimbursed · per 100k residents
13.31,111
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 Nevada 1,111 /100k
2 Kentucky 736 /100k
3 Oklahoma 502 /100k
4 Ohio 493 /100k
5 New Mexico 427 /100k
6 West Virginia 395 /100k
7 Louisiana 364 /100k
8 Nebraska 343 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page70954-0085-10 6,342 Rx · $141,690
500 tablets70954-0085-20 73 Rx · $1,676
Drug total (last 4 qtrs): 6,415 Rx · 452,316 units · $143,367 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Nausea98
Dizziness95
Fatigue93
Pain92
Headache76
Anxiety66
Diarrhoea59

Age at onset

Adolescent2
Adult137
Elderly31

Reporter sex

1,295 reports
Male · 25%
Female · 75%
Unknown · 0%

Serious outcomes

Hospitalization365
Disabling44
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 58 36
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
70954-0085-10 You're viewing this 100 TABLET in 1 BOTTLE (70954-085-10) $0.2117 / ea $21.17 2019-09-12 Active
70954-0085-20 500 TABLET in 1 BOTTLE (70954-085-20) $0.2117 / ea $105.84 2019-09-12 Active

You're viewing the smallest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.2117 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 99% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 70954-0085-10?
NDC 70954-0085-10 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 70954-0085-10 and NDC 70954-0085-20?
Both are Chlorzoxazone 500 mg Tablet — the drug itself is identical. NDC 70954-0085-10 is the 100-count package, while NDC 70954-0085-20 is the 500 tablets package.
What NDC number is used to bill for this package of Chlorzoxazone 500 mg Tablet?
Bill NDC 70954-0085-10 — the 11-digit billing format is 70954008510. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 57 words ▾

INDICATIONS & 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 46 words ▾

DOSAGE & ADMINISTRATION 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 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 116 words ▾

ADVERSE REACTIONS 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 Novitium Pharma LLC at 1-855-204-1431 or FDA at 1-800- FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

🆘 Overdosage 165 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 80 words ▾

HOW SUPPLIED Chlorzoxazone Tablets, USP 500 mg for Oral administration are supplied as follows, White to off-white capsule shaped tablets debossed with N085 on the bisected side: NDC 70954-085-10 100 Tablets NDC 70954-085-20 500 Tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP/NF. Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey-08520 Issued: 07/2020

📋 Description 95 words ▾

DESCRIPTION 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: C 7 H 4 CINO 2 MW 169.57 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 Pregelatinized Starch, Croscarmellose Sodium, Microcrystalline Cellulose, Docusate Sodium, Sodium Benzoate, Colloidal Silicon dioxide, Magnesium Stearate. structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70954-0077-10 · ANI 70954-0135-10 · ANI →
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.