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Carisoprodol 350 mg Tablet, 60-count — NDC 71205-0339-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Carisoprodol 350 mg Tablet, 60-count — NDC 71205-339-60 (Billing 71205-0339-60)

by Proficient Rx LP · 60 TABLET in 1 BOTTLE

This is a package of 60 tablets of Carisoprodol 350 mg Tablet from Proficient Rx LP, marketed since Jan 2014 and currently FDA-listed.

NDC 71205-0339-60
🏷️ FDA NDC (as labeled) 71205-339-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1410/unit — full pricing hub ↓
Product page 71205-0339-30 Also comes in: 30 tablets 71205-339-30 90 tablets 71205-339-90
Rx only Generic On market CIV ⇄ 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) 71205-339-60
Product NDC 71205-339
11-digit billing NDC 71205033960
RxCUI 197446
UNII 21925K482H
UPC 0371205339906
Application # ANDA203374
SPL Set ID 2178e805-8189-459f-a447-21bf1547744a
Established class (EPC) Muscle Relaxant
Physiologic effect Centrally-mediated Muscle Relaxation
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-01-27
Route ORAL
Dosage form TABLET
Substance CARISOPRODOL
TE code (Orange Book) AA · RLD · RS

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

GPI-14 75100020000305
GPI class Carisoprodol
GCN Seq No 004663
GCN 17912
HICL code 001944
Ingredient (HICL) Carisoprodol
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 CARISOPRODOL 350 MG TABLET
FDB brand name Carisoprodol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004663
  • GCN: 17912
  • GPI-14 (Medi-Span): 75100020000305
  • HICL (First Databank): 001944
  • AHFS class code: 12:20.04.00
  • RxCUI (RxNorm): 197446
Why two NDCs? The FDA registers this code as 71205-339-60 — 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 → 71205-0339-60. 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) Carbamic acid esters
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 CARISOPRODOL 350 MG TABLET Ingredient Carisoprodol
📖 What it is MedlinePlus · NLM

Carisoprodol is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuries. Carisoprodol is in a class of medications called skeletal muscle relaxants. It works by acting in the brain and nervous system to allow the muscles to relax.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It relieves discomfort from sudden, painful muscle and bone problems, like a strain, in adults. It is meant for short use, up to two or three weeks.
  • Take it by mouth, usually three times a day and at bedtime, with or without food. Follow your prescriber's directions and don't use it longer than prescribed.
  • It can. Drowsiness, dizziness, and headache are the most common side effects. Don't drive or do hazardous tasks until you know how it affects you.
  • No, it's best to avoid alcohol. It adds to the sedation. The same goes for benzodiazepines, opioids, and tricyclic antidepressants, so tell me about everything you take.
📖 Read our full Carisoprodol 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 $0.1410 $8.46 / 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
71205-0339-30 71205-339-30 Main listing 30 TABLET in 1 BOTTLE 2019-10-01 — Active
71205-0339-60 You're viewing this 60 TABLET in 1 BOTTLE 2019-10-01 — Active
71205-0339-90 71205-339-90 90 TABLET in 1 BOTTLE 2019-10-01 — 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 71205-0339-30?
Both are Carisoprodol 350 mg Tablet — the drug itself is identical. This page's package is the 60-count one, while NDC 71205-0339-30 is the 30 tablets package.
What NDC number is used to bill for this package of Carisoprodol 350 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
Carisoprodol 350 mg 42543-0700-01 Vensun 100 tablets $0.051 AA FDA listed —
carisoprodol 350 mg 16571-0781-01 Rising 100 tablets $0.071 AA Availability likely —
Carisoprodol 350 mg 50228-0109-01 ScieGen 100 tablets $0.071 AA Availability likely —
Carisoprodol 350 mg 50742-0656-01 Ingenus 100 tablets $0.071 AA Availability likely —
Carisoprodol 350 mg 62135-0241-12 Chartwell 120 tablets $0.071 AA Availability likely —
Carisoprodol Tablets, USP, 350 mg 63561-0127-01 Granulation 100 tablets $0.071 AA Availability likely —
Carisoprodol 350 mg 69367-0420-01 Westminster 100 tablets $0.071 AA Availability likely —
Carisoprodol 350 mg 69584-0111-10 Oxford 100 tablets $0.071 AA Availability likely —
carisoprodol 350 mg 65862-0158-01 Aurobindo 100 tablets $0.071 — FDA listed —
Soma 350 mg 00037-2001-01 Viatris 100 tablets $11.298 AA Availability likely —
Carisoprodol 350 mg 45865-0233-30 Medsource 30 tablets — AA FDA listed —
Carisoprodol 350 mg 50090-5953-05 A-S 90 tablets — AA FDA listed —
Carisoprodol 350 mg 50090-5955-00 A-S 30 tablets — AA FDA listed —
Carisoprodol 350 mg 52536-0688-10 Wilshire 100 tablets — AA FDA listed —
Carisoprodol 350 mg 60760-0397-90 St. 90 tablets — AA FDA listed —
Carisoprodol 350 mg 61919-0878-60 Direct_Rx 60 tablets — AA FDA listed —
Carisoprodol 350 mg 63629-2416-01 Bryant 100 tablets — AA FDA listed —
Carisoprodol 350 mg 63629-8477-01 Bryant 1000 tablets — AA FDA listed —
Carisoprodol 350 mg 63629-8478-01 Bryant 500 tablets — AA FDA listed —
Carisoprodol 350 mg 63629-8479-01 Bryant 100 tablets — AA FDA listed —
carisoprodol 350 mg 68071-3421-06 NuCare 60 tablets — AA FDA listed —
Carisoprodol 350 mg 68071-5075-03 NuCare 30 tablets — AA FDA listed —
Carisoprodol 350 mg 70518-2800-00 REMEDYREPACK 60 tablets — AA FDA listed —
carisoprodol 350 mg 70518-3792-00 REMEDYREPACK 90 tablets — AA FDA listed —
Carisoprodol 350 mg 71205-0241-20 Proficient 20 tablets — AA FDA listed —
Carisoprodol 350 mgthis 71205-0339-60 Proficient 60 tablets — AA FDA listed —
Carisoprodol 350 mg 71205-0704-30 Proficient 30 tablets — AA FDA listed —
Carisoprodol 350 mg 71335-1203-00 Bryant 56 tablets — AA FDA listed —
Carisoprodol Tablets, USP, 350 mg 71335-3018-01 Bryant 1000 tablets — AA FDA listed —
carisoprodol 350 mg 71335-9613-00 Bryant 56 tablets — AA FDA listed —
Carisoprodol 350 mg 71335-9621-00 Bryant 56 tablets — AA FDA listed —
Carisoprodol 350 mg 71610-0617-30 Aphena 30 tablets — AA FDA listed —
Carisoprodol 350 mg 71610-0761-30 Aphena 30 tablets — AA FDA listed —
Carisoprodol 350 mg 72162-1524-00 Bryant 1000 tablets — AA FDA listed —
Carisoprodol 350 mg 72162-1928-01 Bryant 100 tablets — AA FDA listed —
Carisoprodol Tablets, USP, 350 mg 72162-2525-00 Bryant 1000 tablets — AA FDA listed —
Carisoprodol 350 mg 72189-0310-30 Directrx 30 tablets — AA FDA listed —
Carisoprodol 350 mg 72189-0386-30 Direct_Rx 30 tablets — AA FDA listed —
Carisoprodol 350 mg 72789-0182-01 PD-Rx 100 tablets — AA FDA listed —
Carisoprodol 350 mg 72789-0190-14 PD-Rx 14 tablets — AA FDA listed —
Carisoprodol Tablets, USP, 350 mg 72789-0477-01 PD-Rx 100 tablets — AA FDA listed —
Carisoprodol 350 mg 76420-0646-01 Asclemed 100 tablets — AA FDA listed —
carisoprodol 350 mg 76420-0853-00 Asclemed 1000 tablets — AA FDA listed —
Carisoprodol 350 mg 80425-0291-01 Advanced 30 tablets — AA FDA listed —
Carisoprodol 350 mg 82868-0062-30 Northwind 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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
ShapeRound
ImprintSG;109
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 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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.

Manufacturer & labeler

LabelerProficient Rx LP
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA203374 (ANDA)
Labeler code71205
First marketedJan 2014
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio1,729 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 107 words ▾

1 INDICATIONS AND USAGE Carisoprodol tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol tablets, USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see Dosage and Administration (2) ]. Carisoprodol tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

(1) Limitations of Use: • Should only be used for acute treatment periods up to two or three weeks (1)

⏱️ Dosage and Administration 57 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose of Carisoprodol tablets, USP is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of carisoprodol tablets, USP use is up to two or three weeks. • Recommended dose is 250 mg to 350 mg three times a day and at bedtime. (2)

💊 Dosage Forms and Strengths 23 words ▾

3 DOSAGE FORMS AND STRENGTHS 350 mg Tablets: round, convex, white tablets, debossed with SG 109 on one side. Tablets: 350 mg (3)

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS Carisoprodol tablets, USP is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. • Acute intermittent porphyria (4) • Hypersensitivity reactions to a carbamate such as meprobamate (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery (5.1) • Additive sedative effects when used with other CNS depressants including alcohol (5.1) • Cases of abuse, dependence, and withdrawal (5.2 , 9.2 , 9.3) • Seizures (5.3)

5.1Sedation Carisoprodol has sedative properties (in the low back pain trials, 13% to 17% of patients who received carisoprodol experienced sedation compared to 6% of patients who received placebo) [ see ADVERSE REACTIONS (6.1) ] and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. There have been post-marketing reports of motor vehicle accidents associated with the use of carisoprodol. Since the sedative effects of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

5.2Abuse, Dependence, and Withdrawal Carisoprodol, the active ingredient in carisoprodol tablets, USP, has been subject to abuse, dependence, and withdrawal, misuse and criminal diversion. [ see Drug Abuse and Dependence (9.1, 9.2, 9.3) . Abuse of carisoprodol tablets, USP poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures, and other disorders. [see over dosage(10)]. Post-marketing experience cases of carisoprodol abuse and dependence have been reported in patients with prolonged use and a history of drug abuse.

Although most of these patients took other drugs of abuse, some patients solely abused carisoprodol. Withdrawal symptoms have been reported following abrupt cessation of carisoprodol after prolonged use. Reported withdrawal symptoms included insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, ataxia, hallucinations, and psychosis.

One of carisoprodol’s metabolites, meprobamate (a controlled substance), may also cause dependence. [see Clinical Pharmacology (12.3)] To reduce the risk of carisoprodol tablets, USP abuse assess the risk of abuse prior to prescribing. After prescribing, limit the length of treatment to three weeks for the relief of acute musculoskeletal discomfort, keep careful prescription records, monitor for signs of abuse and overdose, and educate patients and their families about abuse and on proper storage and disposal.

5.3Seizures There have been post-marketing reports of seizures in patients who received carisoprodol. Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol) [ see Overdosage (10) ].

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache (6.1) To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc. at (855) ‑ 724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice. The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain [ see Clinical Studies (14) ].

In these studies, patients were treated with 250 mg of carisoprodol, 350 mg of carisoprodol, or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74% Caucasian, 16% Black, 9% Asian, and 2% other. There were no deaths and there were no serious adverse reactions in these two trials.

In these two studies, 2.7%, 2%, and 5.4% of patients treated with placebo, 250 mg of carisoprodol, and 350 mg of carisoprodol, respectively, discontinued due to adverse events; 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of carisoprodol, and 350 mg of carisoprodol, respectively, discontinued due to central nervous system adverse reactions. Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with carisoprodol in the two trials described above.

Table 1. Patients with Adverse Reactions in Controlled Studies Adverse Reaction Placebo (n=560) n (%) Carisoprodol 250 mg (n=548) n(%) Carisoprodol 350 mg (n=279) n (%) Drowsiness 31 (6) 73 (13) 47 (17) Dizziness 11 (2) 43 (8) 19 (7) Headache 11 (2) 26 (5) 9 (3)

6.2Postmarketing Experience The following events have been reported during postapproval use of carisoprodol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: Tachycardia, postural hypotension, and facial flushing [ see Overdosage (10) ].

Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures [ see Overdosage (10) ]. Gastrointestinal: Nausea, vomiting, and epigastric discomfort. Hematologic: Leukopenia, pancytopenia.

🔄 Drug Interactions 180 words ▾

7 DRUG INTERACTIONS • CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) - additive sedative effects ( 5.1 , 7.1 )

7.1CNS Depressants The sedative effects of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously. Concomitant use of carisoprodol and meprobamate, a metabolite of carisoprodol, is not recommended [ see Warnings and Precautions (5.1) ].

7.2CYP2C19 Inhibitors and Inducers Carisoprodol is metabolized in the liver by CYP2C19 to form meprobamate [ see Clinical Pharmacology (12.3) ]. Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with carisoprodol could result in increased exposure of carisoprodol and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St.

John's Wort, with carisoprodol could result in decreased exposure of carisoprodol and increased exposure of meprobamate. Low dose aspirin also showed an induction effect on CYP2C19. The full pharmacological impact of these potential alterations of exposures in terms of either efficacy or safety of carisoprodol is unknown.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy: Pregnancy Category C. There are no data on the use of carisoprodol during human pregnancy. Animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival.

The primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations. Teratogenic effects: Animal studies have not adequately evaluated the teratogenic effects of carisoprodol.

There was no increase in the incidence of congenital malformations noted in reproductive studies in rats, rabbits, and mice treated with meprobamate. Retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure. Across studies that indicated an increased risk, the types of malformations were inconsistent.

Nonteratogenic effects: In animal studies, carisoprodol reduced fetal weights, postnatal weight gain, and postnatal survival at maternal doses equivalent to 1 to 1.5 times the human dose (based on a body surface area comparison). Rats exposed to meprobamate in-utero showed behavioral alterations that persisted into adulthood. For children exposed to meprobamate in-utero, one study found no adverse effects on mental or motor development or IQ scores. carisoprodol should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

8.2Labor and Delivery There is no information about the effects of carisoprodol on the mother and the fetus during labor and delivery.

8.3Nursing Mothers Very limited data in humans show that carisoprodol is present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. In one case report, a breast-fed infant received about 4 to 6% of the maternal daily dose through breast milk and experienced no adverse effects. However, milk production was inadequate and the baby was supplemented with formula.

In lactation studies in mice, female pup survival and pup weight at weaning were decreased. This information suggests that maternal use of carisoprodol may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when carisoprodol is administered to a nursing woman.

8.4Pediatric Use The efficacy, safety, and pharmacokinetics of carisoprodol in pediatric patients less than 16 years of age have not been established.

8.5Geriatric Use The efficacy, safety, and pharmacokinetics of carisoprodol in patients over 65 years old have not been established.

8.6Renal Impairment The safety and pharmacokinetics of carisoprodol in patients with renal impairment have not been evaluated. Since carisoprodol is excreted by the kidney, caution should be exercised if carisoprodol is administered to patients with impaired renal function. Carisoprodol is dialyzable by hemodialysis and peritoneal dialysis.

8.7Hepatic Impairment The safety and pharmacokinetics of carisoprodol in patients with hepatic impairment have not been evaluated. Since carisoprodol is metabolized in the liver, caution should be exercised if carisoprodol is administered to patients with impaired hepatic function.

8.8Patients with Reduced CYP2C19 Activity Patients with reduced CYP2C19 activity have higher exposure to carisoprodol. Therefore, caution should be exercised in administration of carisoprodol to these patients [ see Clinical Pharmacology (12.3) ].

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy: Pregnancy Category C. There are no data on the use of carisoprodol during human pregnancy. Animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival.

The primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations. Teratogenic effects: Animal studies have not adequately evaluated the teratogenic effects of carisoprodol.

There was no increase in the incidence of congenital malformations noted in reproductive studies in rats, rabbits, and mice treated with meprobamate. Retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure. Across studies that indicated an increased risk, the types of malformations were inconsistent.

Nonteratogenic effects: In animal studies, carisoprodol reduced fetal weights, postnatal weight gain, and postnatal survival at maternal doses equivalent to 1 to 1.5 times the human dose (based on a body surface area comparison). Rats exposed to meprobamate in-utero showed behavioral alterations that persisted into adulthood. For children exposed to meprobamate in-utero, one study found no adverse effects on mental or motor development or IQ scores. carisoprodol should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

🧒 Pediatric Use 23 words ▾

8.4Pediatric Use The efficacy, safety, and pharmacokinetics of carisoprodol in pediatric patients less than 16 years of age have not been established.

🧓 Geriatric Use 20 words ▾

8.5Geriatric Use The efficacy, safety, and pharmacokinetics of carisoprodol in patients over 65 years old have not been established.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Overdosage of carisoprodol commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures, delirium, hallucinations, dystonic reactions, nystagmus, blurred vision, mydriasis, euphoria, muscular incoordination, rigidity, and/or headache have been reported with carisoprodol overdosage.Serotonin syndrome has been reported with carisoprodol intoxication. Many of the carisoprodol overdoses have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol).

The effects of an overdose of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) can be additive even when one of the drugs has been taken in the recommended dosage. Fatal accidental and non-accidental overdoses of carisoprodol have been reported alone or in combination with CNS depressants. Treatment of Overdosage: Basic life support measures should be instituted as dictated by the clinical presentation of the carisoprodol overdose.Vomiting should not be induced because of the risk of CNS and respiratory depression, and subsequent aspiration.

Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.

For decontamination in cases of severe toxicity, activated charcoal should be considered in a hospital setting in patients with large overdoses who present early and are not demonstrating CNS depression and can protect their airway. For more information on the management of an overdose of carisoprodol, contact a Poison Control Center .

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of carisoprodol in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified. In animal studies, muscle relaxation induced by carisoprodol is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain.

12.2Pharmacodynamics carisoprodol is a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles. A metabolite of carisoprodol, meprobamate, has anxiolytic and sedative properties. The degree to which these properties of meprobamate contribute to the safety and efficacy of carisoprodol is unknown.

12.3Pharmacokinetics The pharmacokinetics of carisoprodol and its metabolite meprobamate were studied in a crossover study of 24 healthy subjects (12 male and 12 female) who received single doses of 250 mg and 350 mg carisoprodol (see Table 2). The exposure of carisoprodol and meprobamate was dose proportional between the 250 mg and 350 mg doses. The C max of meprobamate was 2.5 ± 0.5 mcg/mL (mean ± SD) after administration of a single 350 mg dose of carisoprodol tablets, which is approximately 30% of the C max of meprobamate (approximately 8 mcg/mL) after administration of a single 400 mg dose of meprobamate.

Table 2. Pharmacokinetic Parameters of Carisoprodol and Meprobamate (Mean ± SD, n=24) 250 mg Carisoprodol 350 mg Carisoprodol Carisoprodol C max (mcg/mL) 1.2 ± 0.5 1.8 ±

1.0AUC inf (mcg*hr/mL) 4.5 ± 3.1 7.0 ±

5.0T max (hr) 1.5 ± 0.8 1.7 ±

0.8T1/2 (hr) 1.7 ± 0.5 2.0 ±

0.5Meprobamate C max (mcg/mL) 1.8 ± 0.3 2.5 ±

0.5AUC inf (mcg*hr/mL) 32 ± 6.2 46 ±

9.0T max (hr) 3.6 ± 1.7 4.5 ±

1.9T1/2 (hr) 9.7 ± 1.7 9.6 ±

1.5Absorption: Absolute bioavailability of carisoprodol has not been determined. The mean time to peak plasma concentrations (T max ) of carisoprodol was approximately 1.5 to 2 hours. Co-administration of a high-fat meal with carisoprodol (350 mg tablet) had no effect on the pharmacokinetics of carisoprodol.

Therefore, carisoprodol may be administered with or without food. Metabolism: The major pathway of carisoprodol metabolism is via the liver by cytochrome enzyme CYP2C19 to form meprobamate. This enzyme exhibits genetic polymorphism (see Patients with Reduced CYP2C19 Activity below).

Elimination: Carisoprodol is eliminated by both renal and non-renal routes with a terminal elimination half-life of approximately 2 hours. The half-life of meprobamate is approximately 10 hours. Gender: Exposure of carisoprodol is higher in female than in male subjects (approximately 30% to 50% on a weight adjusted basis).

Overall exposure of meprobamate is comparable between female and male subjects. Patients with Reduced CYP2C19 Activity: Carisoprodol should be used with caution in patients with reduced CYP2C19 activity. Published studies indicate that patients who are poor CYP2C19 metabolizers have a 4-fold increase in exposure to carisoprodol, and concomitant 50% reduced exposure to meprobamate compared to normal CYP2C19 metabolizers.

The prevalence of poor metabolizers in Caucasians and African Americans is approximately 3% to 5% and in Asians is approximately 15% to 20%.

🧬 Mechanism of Action 51 words ▾

12.1Mechanism of Action The mechanism of action of carisoprodol in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified. In animal studies, muscle relaxation induced by carisoprodol is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain.

📦 How Supplied / Storage and Handling 54 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Carisoprodol Tablets, USP 350 mg: round, convex, white tablets, debossed with SG 109 on one side; available in bottles of 30 (NDC 71205-339-30), bottles of 60 (NDC 71205-339-60), and the bottles of 90 (NDC 71205-339-90). Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 115 words ▾

11 DESCRIPTION Carisoprodol tablets, USP are available as 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor. It is very slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH.

Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C 12 H 24 N 2 O 4 , with a molecular weight of 260.33. The structural formula is: Other ingredients in Carisoprodol tablets USP, 350 mg include microcrystalline cellulose, lactose monohydrate, pregelatinized starch (botanical source: maize), croscarmellose sodium, povidone, silicon dioxide and magnesium stearate. structural formula of CARISOPRODOL

💬 Information for Patients 208 words ▾

17 PATIENT COUNSELING INFORMATION Patients should be advised to contact their physician if they experience any adverse reactions to carisoprodol.

17.1Sedation Patients should be advised that carisoprodol may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking carisoprodol before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery [ see Warnings and Precautions (5.1) ].

17.2Avoidance of Alcohol and Other CNS Depressants Patients should be advised to avoid alcoholic beverages while taking carisoprodol and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives [ see Warnings and Precautions (5.1) ].

17.3Carisoprodol Should Only Be Used for Short-Term Treatment Patients should be advised that treatment with carisoprodol should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort. In the post-marketing experience with carisoprodol, cases of dependence, withdrawal, and abuse have been reported with prolonged use. If the musculoskeletal symptoms still persist, patients should contact their healthcare provider for further evaluation.

Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 USA Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Rev. 01/19

🍼 Nursing Mothers 116 words ▾

8.3Nursing Mothers Very limited data in humans show that carisoprodol is present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. In one case report, a breast-fed infant received about 4 to 6% of the maternal daily dose through breast milk and experienced no adverse effects. However, milk production was inadequate and the baby was supplemented with formula.

In lactation studies in mice, female pup survival and pup weight at weaning were decreased. This information suggests that maternal use of carisoprodol may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when carisoprodol is administered to a nursing woman.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics The pharmacokinetics of carisoprodol and its metabolite meprobamate were studied in a crossover study of 24 healthy subjects (12 male and 12 female) who received single doses of 250 mg and 350 mg carisoprodol (see Table 2). The exposure of carisoprodol and meprobamate was dose proportional between the 250 mg and 350 mg doses. The C max of meprobamate was 2.5 ± 0.5 mcg/mL (mean ± SD) after administration of a single 350 mg dose of carisoprodol tablets, which is approximately 30% of the C max of meprobamate (approximately 8 mcg/mL) after administration of a single 400 mg dose of meprobamate.

Table 2. Pharmacokinetic Parameters of Carisoprodol and Meprobamate (Mean ± SD, n=24) 250 mg Carisoprodol 350 mg Carisoprodol Carisoprodol C max (mcg/mL) 1.2 ± 0.5 1.8 ±

1.0AUC inf (mcg*hr/mL) 4.5 ± 3.1 7.0 ±

5.0T max (hr) 1.5 ± 0.8 1.7 ±

0.8T1/2 (hr) 1.7 ± 0.5 2.0 ±

0.5Meprobamate C max (mcg/mL) 1.8 ± 0.3 2.5 ±

0.5AUC inf (mcg*hr/mL) 32 ± 6.2 46 ±

9.0T max (hr) 3.6 ± 1.7 4.5 ±

1.9T1/2 (hr) 9.7 ± 1.7 9.6 ±

1.5Absorption: Absolute bioavailability of carisoprodol has not been determined. The mean time to peak plasma concentrations (T max ) of carisoprodol was approximately 1.5 to 2 hours. Co-administration of a high-fat meal with carisoprodol (350 mg tablet) had no effect on the pharmacokinetics of carisoprodol.

Therefore, carisoprodol may be administered with or without food. Metabolism: The major pathway of carisoprodol metabolism is via the liver by cytochrome enzyme CYP2C19 to form meprobamate. This enzyme exhibits genetic polymorphism (see Patients with Reduced CYP2C19 Activity below).

Elimination: Carisoprodol is eliminated by both renal and non-renal routes with a terminal elimination half-life of approximately 2 hours. The half-life of meprobamate is approximately 10 hours. Gender: Exposure of carisoprodol is higher in female than in male subjects (approximately 30% to 50% on a weight adjusted basis).

Overall exposure of meprobamate is comparable between female and male subjects. Patients with Reduced CYP2C19 Activity: Carisoprodol should be used with caution in patients with reduced CYP2C19 activity. Published studies indicate that patients who are poor CYP2C19 metabolizers have a 4-fold increase in exposure to carisoprodol, and concomitant 50% reduced exposure to meprobamate compared to normal CYP2C19 metabolizers.

The prevalence of poor metabolizers in Caucasians and African Americans is approximately 3% to 5% and in Asians is approximately 15% to 20%.

🧬 Pharmacodynamics 45 words ▾

12.2Pharmacodynamics carisoprodol is a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles. A metabolite of carisoprodol, meprobamate, has anxiolytic and sedative properties. The degree to which these properties of meprobamate contribute to the safety and efficacy of carisoprodol is unknown.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The safety and efficacy of carisoprodol for the relief of acute, idiopathic mechanical low back pain was evaluated in two, 7-day, double blind, randomized, multicenter, placebo controlled, U.S. trials (Studies 1 and 2). Patients had to be 18 to 65 years old and had to have acute back pain ( ≤ 3 days of duration) to be included in the trials. Patients with chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis); with a history of spinal pathology (e.g., herniated nucleus pulposis, spondylolisthesis or spinal stenosis); with inflammatory back pain, or with evidence of a neurologic deficit were excluded from participation.Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was prohibited.

In Study 1, patients were randomized to one of three treatment groups (i.e., carisoprodol 250 mg,carisoprodol 350 mg, or placebo) and in Study 2 patients were randomized to two treatment groups (i.e., carisoprodol 250 mg or placebo). In both studies, patients received study medication three times a day and at bedtime for seven days. The primary endpoints were the relief from starting backache and the global impression of change, as reported by patients, on Study Day 3.

Both endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome) in both studies. The primary statistical comparison was between the carisoprodol 250 mg and placebo groups in both studies. The proportion of patients who used concomitant acetaminophen, NSAIDs, tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was similar in the treatment groups.

The results for the primary efficacy evaluations in the acute, low back pain studies are presented in Table 3. Table 3. Results of the Primary Efficacy Endpoints a in Studies 1 and 2 Study Parameter Placebo carisoprodol 250 mg carisoprodol 350 mg a The primary efficacy endpoints (Relief from Starting Backache and Global Impression of Change) were assessed by the patients on Study Day 3.

These endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome). b Mean is the least squared mean and SE is the standard error of the mean. The ANOVA model was used for the primary statistical comparison between the carisoprodol 250 mg and placebo groups. 1 Number of Patients n=269 n=264 n=273 Relief from Starting Backache, Mean (SE) b 1.4 (0.1) 1.8 (0.1) 1.8 (0.1) Difference between carisoprodol and Placebo, Mean (SE) b (95% CI) 0.4 (0.2, 0.5) 0.4 (0.2, 0.6) Global Impression of change, Mean (SE) b 1.9 (0.1) 2.2 (0.1) 2.2 (0.1) Difference between carisoprodol and Placebo, Mean (SE) b (95% CI) 0.2 (0.1, 0.4) 0.3 (0.1, 0.4) 2 Number of Patients n=278 n=269 Relief from Starting Backache, Mean (SE) b 1.1 (0.1) 1.8 (0.1) Difference between carisoprodol and Placebo, Mean (SE) b (95% CI) 0.7 (0.5, 0.9) Global Impression of change, Mean (SE) b 1.7 (0.1) 2.2 (0.1) Difference between carisoprodol and Placebo, Mean (SE) b (95% CI) 0.5 (0.4, 0.7) Patients treated with carisoprodol experienced improvement in function as measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3 and 7.

🔒 Drug Abuse and Dependence ~1 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Carisoprodol tablets, USP contains carisoprodol, USP a Schedule IV controlled substance. Carisoprodol has been subject to abuse, misuse, and criminal diversion for nontherapeutic use [ see Warnings and Precautions (5.2)] .

9.2Abuse Abuse of carisoprodol poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures and other disorders . [see Warnings and Precautions (5.2) and over dosage(10)]. Patients at high risk of carisoprodol abuse may include those with prolonged use of carisoprodol, with a history of drug abuse, or those who use carisoprodol in combination with other abused drugs. Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological effects.

Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. Drug abuse and drug addiction are separate and distinct from physical dependence and tolerance (for example, abuse or addiction may not be accompanied by tolerance or physical dependence) [ see Drug Abuse and Dependance(9.3)]

9.3Dependence Tolerance is when a patient’s reaction to a specific dosage and concentration is progressively reduced in the absence of disease progression, requiring an increase in the dosage to maintain the same. Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. Both tolerance and physical dependence have been reported with the prolonged use of carisoprodol.

Reported withdrawal symptoms with carisoprodol include insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, anxiety, ataxia, hallucinations, and psychosis. Instruct patients taking large doses of carisoprodol or those taking the drug for a prolonged time to not abruptly stop carisoprodol. [ see Warnings and Precautions (5.2)].

🔒 Controlled Substance 34 words ▾

9.1Controlled Substance Carisoprodol tablets, USP contains carisoprodol, USP a Schedule IV controlled substance. Carisoprodol has been subject to abuse, misuse, and criminal diversion for nontherapeutic use [ see Warnings and Precautions (5.2)] .

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol. Carisoprodol was not formally evaluated for genotoxicity. In published studies, carisoprodol was mutagenic in the in vitro mouse lymphoma cell assay in the absence of metabolizing enzymes, but was not mutagenic in the presence of metabolizing enzymes.

Carisoprodol was clastogenic in the in vitro chromosomal aberration assay using Chinese hamster ovary cells with or without the presence of metabolizing enzymes. Other types of genotoxic tests resulted in negative findings. Carisoprodol was not mutagenic in the Ames reverse mutation assay using S. typhimurium strains with or without metabolizing enzymes, and was not clastogenic in an in vivo mouse micronucleus assay of circulating blood cells.

Carisoprodol was not formally evaluated for effects on fertility. Published reproductive studies of carisoprodol in mice found no alteration in fertility although an alteration in reproductive cycles characterized by a greater time spent in estrus was observed at a carisoprodol dose of 1200 mg/kg/day. In a 13-week toxicology study that did not determine fertility, mouse testes weight and sperm motility were reduced at a dose of 1200 mg/kg/day.

In both studies, the no effect level was 750 mg/kg/day, corresponding to approximately 2.6 times the human equivalent dosage of 350 mg four times a day, based on a body surface area comparison The significance of these findings for human fertility is not known.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol. Carisoprodol was not formally evaluated for genotoxicity. In published studies, carisoprodol was mutagenic in the in vitro mouse lymphoma cell assay in the absence of metabolizing enzymes, but was not mutagenic in the presence of metabolizing enzymes.

Carisoprodol was clastogenic in the in vitro chromosomal aberration assay using Chinese hamster ovary cells with or without the presence of metabolizing enzymes. Other types of genotoxic tests resulted in negative findings. Carisoprodol was not mutagenic in the Ames reverse mutation assay using S. typhimurium strains with or without metabolizing enzymes, and was not clastogenic in an in vivo mouse micronucleus assay of circulating blood cells.

Carisoprodol was not formally evaluated for effects on fertility. Published reproductive studies of carisoprodol in mice found no alteration in fertility although an alteration in reproductive cycles characterized by a greater time spent in estrus was observed at a carisoprodol dose of 1200 mg/kg/day. In a 13-week toxicology study that did not determine fertility, mouse testes weight and sperm motility were reduced at a dose of 1200 mg/kg/day.

In both studies, the no effect level was 750 mg/kg/day, corresponding to approximately 2.6 times the human equivalent dosage of 350 mg four times a day, based on a body surface area comparison The significance of these findings for human fertility is not known.

📄 Package Label / Principal Display Panel 18 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL NDC 71205-339-90 Carisoprodol Tablets, USP CIV 350 mg 90 Tablets R X Only 71205-339-90

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 Carisoprodol — the program that covers self-administered drugs. 7 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 Carisoprodol. 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
$856.8K
Claims incl. refills
64.2K
Beneficiaries
36.6K
Spend / beneficiary
$23.39
Spend / claim
$13.35
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

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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) ✓ Available
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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.
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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 Proficient Rx LP. 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 (71205-0339-30), 90 tablets (71205-0339-90). 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?
Proficient Rx LP 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.
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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.