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RILUZOLE 50 mg Tablet, Film Coated, 60-count — NDC 69076-0200-60 package photo

RILUZOLE 50 mg Tablet, Film Coated, 60-count

by Florida Pharmaceutical Products, LLC · 60 TABLET, FILM COATED in 1 BOTTLE (69076-200-60)
NDC 69076-0200-60
🏷️ FDA NDC (as labeled) 69076-200-60 billing pads the product segment with a zero
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 →

🆔 Identity & classification

FDA NDC (as labeled) 69076-200-60
Product NDC 69076-200
11-digit billing NDC 69076020060
NCPDP billing unit EA — each (per item)
RxCUI 199206
UNII 7LJ087RS6F
UPC 0369076200609
Application # ANDA206045
SPL Set ID ccead445-970c-46a1-9532-2848cc2aa3b6
Established class (EPC) Benzothiazole
Chemical class Benzothiazoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-01-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance RILUZOLE
GPI-14 74503070000320
GPI class Riluzole
GCN Seq No 024508
GCN 12120
HICL code 010247
Ingredient (HICL) Riluzole
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 H6I
Therapeutic class — specific (HIC3) Amyotrophic Lateral Sclerosis Agents
AHFS code 28:44.00.00
AHFS class Amyotrophic Lateral Sclerosis(Als) Agent
FDB label name RILUZOLE 50 MG TABLET
FDB brand name Riluzole
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 69076-200-60 — 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 → 69076-0200-60. 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 Benzothiazole class.

Pharmacologic class Benzothiazole
Drug family (ATC) Other nervous system drugs
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

LabelerFlorida Pharmaceutical Products, LLC
Application holderKENTON CHEMICALS AND PHARMACEUTICALS CORP
FDA applicationANDA206045 (ANDA)
Labeler code69076
First marketedJan 2020
Product typeHuman Prescription Drug
Portfolio42 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 RILUZOLE 50 MG TABLET Ingredient Riluzole
📖 What it is MedlinePlus · NLM

Riluzole is used to treat amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). Riluzole is in a class of medications called benzothiazoles. It works by changing the activity of certain natural substances in the body that affect nerves and muscles.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Riluzole doesn't cure ALS, and it won't reverse the damage already done. It's approved to treat the disease, but honestly, scientists still don't fully understand the exact way it...
  • What exactly does riluzole do for ALS — does it cure it?
  • Food — especially a high-fat meal — can cut the amount of riluzole your body absorbs quite significantly. To get the most from each dose, take it at least 1 hour before eating or 2...
  • Why do I have to take it on an empty stomach? Can I take it with a light snack?
📖 Read our full Riluzole 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.

🧪 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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

10 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 DailyMedingredient 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 $0.284 $17.03 / 60 tablets
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 $0.9007 $54.04 / 60 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Sep 2022 Jan 2026 Aug 2026 $0.538 $0.269
▼ Down 24% over the last 21 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
Riluzole 50 mgthis 69076-0200-60 Florida 60 tablets $0.284 AB Availability likely
Riluzole 50 mg 42291-0775-60 AvKARE 60 tablets AB FDA listed
Riluzole 50 mg 62756-0538-18 Sun 1000 tablets FDA listed
Riluzole 50 mg 67877-0286-05 Ascend 500 tablets AB FDA listed
riluzole 50 mg 68462-0381-10 Glenmark 1000 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

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 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.

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

Medicare Part D (outpatient prescription) spending for Riluzole — the program that covers self-administered drugs. 3 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 Riluzole. 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
$1.52M
Claims incl. refills
12.4K
Beneficiaries
6.7K
Spend / beneficiary
$227.59
Spend / claim
$122.52
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69076-0200-60 You're viewing this 60 TABLET, FILM COATED in 1 BOTTLE (69076-200-60) 2020-01-01 Active

📄 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 29 words

1 INDICATIONS AND USAGE Riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (ALS) (1)

⏱️ Dosage and Administration 80 words

2 DOSAGE AND ADMINISTRATION The recommended dosage for riluzole tablets is 50 mg taken orally twice daily. Riluzole tablets should be taken at least 1 hour before or 2 hours after a meal [see Clinical Pharmacology (12.3)]. Measure serum aminotransferases before and during treatment with riluzole tablets [see Warnings and Precautions (5.1)].

Recommended dosage: 50 mg twice daily, taken at least 1 hour before or 2 hours after a meal (2) Measure serum aminotransferases before and during treatment (2, 5.1)

💊 Dosage Forms and Strengths 27 words

3 DOSAGE FORMS AND STRENGTHS Tablets: 50mg white to off-white, film-coated, capsule-shaped and engraved with “795” on one side, plain on the other. Tablets: 50 mg (3)

Contraindications 48 words

4 CONTRAINDICATIONS Riluzole tablets is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see Adverse Reactions (6.1)]. Patients with a history of severe hypersensitivity reactions to riluzole tablets or to any of its components (4)

⚠️ Warnings and Cautions ~2 min read

5 WARNINGS AND PRECAUTIONS

5.1 Hepatic Injury

5.2 Neutropenia

5.3Interstitial Lung Disease Hepatic injury: Use of riluzole tablets is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times upper limit of normal; discontinue riluzole tablets if there is evidence of liver dysfunction (5.1) Neutropenia: Advise patients to report any febrile illness (5.2) Interstitial lung disease: Discontinue riluzole tablets if interstitial lung disease develops (5.3)

5.1Hepatic Injury Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking riluzole tablets. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon rechallenge with riluzole tablets. In clinical studies, the incidence of elevations in hepatic transaminases was greater in riluzole-treated patients than placebo-treated patients.

The incidence of elevations of ALT above 5 times the upper limit of normal (ULN) was 2% in riluzole -treated patients. Maximum increases in ALT occurred within 3 months after starting riluzole tablets. About 50% and 8% of riluzole-treated patients in pooled Studies 1 and 2, had at least one elevated ALT level above ULN and above 3 times ULN, respectively [see Clinical Studies (14)].

Monitor patients for signs and symptoms of hepatic injury, every month for the first 3 months of treatment, and periodically thereafter. The use of riluzole tablets is not recommended if patients develop hepatic transaminases levels greater than 5 times the ULN. Discontinue riluzole tablets if there is evidence of liver dysfunction (e.g., elevated bilirubin).

5.2Neutropenia Cases of severe neutropenia (absolute neutrophil count less than 500 per mm3) within the first 2 months of riluzole treatment have been reported. Advise patients to report febrile illnesses.

5.3Interstitial Lung Disease Interstitial lung disease, including hypersensitivity pneumonitis, has occurred in patients taking riluzole tablets. Discontinue riluzole tablets immediately if interstitial lung disease develops.

5.1Hepatic Injury Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking riluzole tablets. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon rechallenge with riluzole tablets. In clinical studies, the incidence of elevations in hepatic transaminases was greater in riluzole-treated patients than placebo-treated patients.

The incidence of elevations of ALT above 5 times the upper limit of normal (ULN) was 2% in riluzole -treated patients. Maximum increases in ALT occurred within 3 months after starting riluzole tablets. About 50% and 8% of riluzole-treated patients in pooled Studies 1 and 2, had at least one elevated ALT level above ULN and above 3 times ULN, respectively [see Clinical Studies (14)].

Monitor patients for signs and symptoms of hepatic injury, every month for the first 3 months of treatment, and periodically thereafter. The use of riluzole tablets is not recommended if patients develop hepatic transaminases levels greater than 5 times the ULN. Discontinue riluzole tablets if there is evidence of liver dysfunction (e.g., elevated bilirubin).

5.2Neutropenia Cases of severe neutropenia (absolute neutrophil count less than 500 per mm3) within the first 2 months of riluzole treatment have been reported. Advise patients to report febrile illnesses.

5.3Interstitial Lung Disease Interstitial lung disease, including hypersensitivity pneumonitis, has occurred in patients taking riluzole tablets. Discontinue riluzole tablets immediately if interstitial lung disease develops.

🤒 Adverse Reactions ~2 min read

6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in the labeling: Hepatic Injury [see Warnings and Precautions (5.1)] Neutropenia [see Warnings and Precautions (5.2)] Interstitial lung disease [see Warnings and Precautions (5.3)] Most common adverse reactions (incidence greater than or equal to 5% and greater than placebo) were asthenia, nausea, dizziness, decreased lung function, and abdominal pain (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Quinn Pharmaceuticals at 954-755-0502 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinial Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Controlled Clinical Trials In the placebo-controlled clinical trials in patients with ALS (Study 1 and 2), a total of 313 patients received riluzole tablets 50 mg twice daily [see Clinical Studies (14)]. The most common adverse reactions in the riluzole group (in at least 5% of patients and more frequently than in the placebo group) were asthenia, nausea, dizziness, decreased lung function, and abdominal pain.

The most common adverse reactions leading to discontinuation in the riluzole group were nausea, abdominal pain, constipation, and elevated ALT. There was no difference in rates of adverse reactions leading to discontinuation in females and males. However, the incidence of dizziness was higher in females (11%) than in males (4%).

The adverse reaction profile was similar in older and younger patients. There were insufficient data to determine if there were differences in the adverse reaction profile in different races. Table 1 lists adverse reactions that occurred in at least 2% of riluzole-treated patients (50 mg twice daily) in pooled Study 1 and 2, and at a higher rate than placebo.

Riluzole Tablets 50 mg twice Daily (N=313) Placebo (N=320) Asthenia 19% 12% Nausea 16% 11% Decreased lung function 10% 9% Hypertension 5% 4% Abdominal pain 5% 4% Vomiting 4% 2% Arthralgia 4% 3% Dizziness 4% 3% Dry mouth 4% 3% Insomnia 4% 3% Pruritus 4% 3% Tachycardia 3% 1% Flatulence 3% 2% Increased cough 3% 2% Peripheral edema 3% 2% Urinary Tract Infection 3% 2% Circumoral paresthesia 2% 0% Somnolence 2% 1% Vertigo 2% 1% Eczema 2% 1%

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of riluzole tablets. 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. Acute hepatitis and icteric toxic hepatitis [see Warnings and Precautions (5.1)] Renal tubular impairment Pancreatitis

🔄 Drug Interactions ~2 min read

7 DRUG INTERACTIONS

7.1 Agents that may Increase Riluzole Blood Concentrations

7.2 Agents that may Decrease Riluzole Plasma Concentrations

7.3Hepatotoxic Drugs Strong to moderate CYP1A2 inhibitors: Coadministration may increase riluzole -associated adverse reactions (7.1) Strong to moderate CYP1A2 inducers: Coadministration may result in decreased efficacy (7.2) Hepatotoxic drugs: Riluzole-treated patients that take other hepatotoxic drugs may be at increased risk for hepatotoxicity (7.3)

7.1Agents that may Increase Riluzole Blood Concentrations CYP1A2 inhibitors Co-administration of riluzole (a CYP1A substrate) with CYP1A2 inhibitors was not evaluated in a clinical trial; however, in vitro findings suggest an increase in riluzole exposure is likely. The concomitant use of strong or moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton) with riluzole may increase the risk of riluzole-associated adverse reactions [see Clinical Pharmacology (12.3)].

7.2Agents that may Decrease Riluzole Plasma Concentrations CYP1A2 inducers Co-administration of riluzole (a CYP1A substrate) with CYP1A2 inducers was not evaluated in a clinical trial; however, in vitro findings suggest a decrease in riluzole exposure is likely. Lower exposures may result in decreased efficacy [see Clinical Pharmacology (12.3)].

7.3Hepatotoxic Drugs Clinical trials in ALS patients excluded patients on concomitant medications which were potentially hepatotoxic (e.g., allopurinol, methyldopa, sulfasalazine). Riluzole-treated patients who take other hepatotoxic drugs may be at an increased risk for hepatotoxicity [see Warnings and Precautions (5.1)].

7.1Agents that may Increase Riluzole Blood Concentrations CYP1A2 inhibitors Co-administration of riluzole (a CYP1A substrate) with CYP1A2 inhibitors was not evaluated in a clinical trial; however, in vitro findings suggest an increase in riluzole exposure is likely. The concomitant use of strong or moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton) with riluzole may increase the risk of riluzole-associated adverse reactions [see Clinical Pharmacology (12.3)].

7.2Agents that may Decrease Riluzole Plasma Concentrations CYP1A2 inducers Co-administration of riluzole (a CYP1A substrate) with CYP1A2 inducers was not evaluated in a clinical trial; however, in vitro findings suggest a decrease in riluzole exposure is likely. Lower exposures may result in decreased efficacy [see Clinical Pharmacology (12.3)].

7.3Hepatotoxic Drugs Clinical trials in ALS patients excluded patients on concomitant medications which were potentially hepatotoxic (e.g., allopurinol, methyldopa, sulfasalazine). Riluzole-treated patients who take other hepatotoxic drugs may be at an increased risk for hepatotoxicity [see Warnings and Precautions (5.1)].

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

8.7Japanese Patients Pregnancy: Based on animal data, may cause fetal harm (8.1) See 17 for PATIENT COUNSELING INFORMATION.

8.1Pregnancy Risk Summary There are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. The background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

In studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see Data]. Based on these results, women should be advised of a possible risk to the fetus associated with use of riluzole during pregnancy. Data Animal Data Oral administration of riluzole (3, 9, or 27 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreases in fetal growth (body weight and length) at the high dose.

The mid dose, a no-effect dose for embryofetal developmental toxicity, is approximately equal to the recommended human daily dose (RHDD, 100 mg) on a mg/m² basis. When riluzole was administered orally (3, 10, or 60 mg/kg/day) to pregnant rabbits during the period of organogenesis, embryofetal mortality was increased at the high dose and fetal body weight was decreased and morphological variations increased at all but the lowest dose tested. The no-effect dose (3 mg/kg/day) for embryofetal developmental toxicity is less than the RHDD on a mg/m² basis.

Maternal toxicity was observed at the highest dose tested in rat and rabbit. When riluzole was orally administered (3, 8, or 15 mg/kg/day) to male and female rats prior to and during mating and to female rats throughout gestation and lactation, increased embryofetal mortality and decreased postnatal offspring viability, growth, and functional development were observed at the high dose. The mid dose, a no-effect dose for pre-and postnatal developmental toxicity, is approximately equal to the RHDD on a mg/m² basis.

8.2Lactation Risk Summary It is not known if riluzole is excreted in human milk. Riluzole or its metabolites have been detected in milk of lactating rat. Women should be advised that many drugs are excreted in human milk and that the potential for serious adverse reactions in nursing infants from riluzole is unknown.

8.3Females and Males of Reproductive Potential In rats, oral administration of riluzole resulted in decreased fertility indices and increases in embryolethality [see Nonclinical Toxicology (13.1)].

8.4Pediatric Use Safety and effectiveness of riluzole tablets in pediatric patients have not been established.

8.5Geriatric Use In clinical studies of riluzole tablets, 30% of patients were 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

8.6Hepatic Impairment Patients with mild [Child-Pugh's (CP) score A] or moderate (CP score B) hepatic impairment had increases in AUC compared to patients with normal hepatic function. Thus, patients with mild or moderate hepatic impairment may be at increased of adverse reactions. The impact of severe hepatic impairment on riluzole exposure is unknown.

Use of riluzole tablets is not recommended in patients with baseline elevation of elevations of serum aminotransferases greater than 5 times upper limit of normal or evidence of liver dysfunction (e.g., elevated bilirubin) [Clinical Pharmaco…

🆘 Overdosage 64 words

10 OVERDOSAGE Reported symptoms of overdose following ingestion of riluzole ranging from 1.5 to 3 grams (30 to 60 times the recommended dose) included acute toxic encephalopathy, coma, drowsiness, memory loss, and methemoglobinemia. No specific antidote for the treatment of riluzole overdose is available. For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.

🧬 Clinical Pharmacology ~3 min read

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.1Mechanism of Action The mechanism by which riluzole exerts its therapeutic effects in patients with ALS is unknown.

12.2Pharmacodynamics The clinical pharmacodynamics of riluzole has not been determined in humans.

12.3Pharmacokinetics Table 2 displays the pharmacokinetic parameters of riluzole. Table 2. Pharmacokinetic Parameters of Riluzole Absorption Bioavailability (oral) Approximately 60% Dose Proportionality Linear over a dose range of 25 mg to 100 mg every 12 hours (1/2 to 2 times the recommended dosage) Food effect AUC ↓ 20% and Cmax ↓ 45% (high fat meal) Distribution Plasma Protein Binding 96% (Mainly to albumin and lipoproteins) Elimination Elimination half-life 12 hours (CV=35%) The high interindividual variability in the clearance of riluzole is potentially attributable to variability of CYP1A2.

The clinical implications are not known. Accumulation Approximately 2-fold Metabolism Fraction metabolized (% dose) At least 88% Primary metabolic pathway(s) [in vitro] Oxidation: CYP1A2 Direct and sequential glucoronidation: UGT-HP4 Active Metabolites Some metabolites appear pharmacologically active in vitro, but the clinical implications are not known. Excretion Primary elimination pathways (% dose) Feces: 5% Urine: 90% (2% unchanged riluzole) Specific Populations Hepatic Impairment Compared with healthy volunteers, the AUC of riluzole was approximately 1.7-fold greater in patients with mild chronic hepatic impairment (CP score A) and approximately 3-fold greater in patients with moderate chronic hepatic impairment (CP score B).

The pharmacokinetics of riluzole have not been studied in patients with severe hepatic impairment (CP score C) [see Use in Specific Populations (8.6)]. Race The clearance of riluzole was 50% lower in male Japanese subjects than in Caucasian subjects, after normalizing for body weight [see Use in Specific Populations (8.7)]. Gender The mean AUC of riluzole was approximately 45% higher in female patients than male patients.

Smokers The clearance of riluzole in tobacco smokers was 20% greater than in nonsmokers. Geriatric Patients and Patients with Moderate to Severe Renal Impairment Age 65 years or older, and moderate to severe renal impairment do not have a meaningful effect on the pharmacokinetics of riluzole. The pharmacokinetics of riluzole in patients undergoing hemodialysis are unknown.

Drug Interaction Studies Drugs Highly Bound To Plasma Proteins Riluzole and warfarin are highly bound to plasma proteins. In vitro, riluzole did not show any displacement of warfarin from plasma proteins. Riluzole binding to plasma proteins was unaffected by warfarin, digoxin, imipramine and quinine at high therapeutic concentrations in vitro.

12.1Mechanism of Action The mechanism by which riluzole exerts its therapeutic effects in patients with ALS is unknown.

12.2Pharmacodynamics The clinical pharmacodynamics of riluzole has not been determined in humans.

12.3Pharmacokinetics Table 2 displays the pharmacokinetic parameters of riluzole. Table 2. Pharmacokinetic Parameters of Riluzole Absorption Bioavailability (oral) Approximately 60% Dose Proportionality Linear over a dose range of 25 mg to 100 mg every 12 hours (1/2 to 2 times the recommended dosage) Food effect AUC ↓ 20% and Cmax ↓ 45% (high fat meal) Distribution Plasma Protein Binding 96% (Mainly to albumin and lipoproteins) Elimination Elimination half-life 12 hours (CV=35%) The high interindividual variability in the clearance of riluzole is potentially attributable to variability of CYP1A2.

The clinical implications are not known. Accumulation Approximately 2-fold Metabolism Fraction metabolized (% dose) At least 88% Primary metabolic pathway(s) [in vitro] Oxidation: CYP1A2 Direct and sequential glucoronidation: UGT-HP4 Active Metabolites Some metabolites appear pharmacologically active in vitro, but the clinical implications are not known. Excreti…

📦 How Supplied / Storage and Handling 54 words

16 HOW SUPPLIED/STORAGE AND HANDLING Riluzole Tablets, USP 50 mg are white to off-white, film-coated, capsule-shaped and engraved with “795” on one side, plain on the other. Riluzole is supplied in bottles of 60 tablets, NDC 69076-200-60. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from bright light.

📋 Description 111 words

11 DESCRIPTION Riluzole is a member of the benzothiazole class. The chemical designation for riluzole is 2-amino-6-(trifluoromethoxy) benzothiazole. Its molecular formula is C8H5F3N2OS, and its molecular weight is 234.2. The chemical structure is: Riluzole is a white to slightly yellow powder that is very soluble in dimethylformamide, dimethylsulfoxide, and methanol; freely soluble in dichloromethane; sparingly soluble in

0.1 N HCl; and very slightly soluble in water and in

0.1N NaOH. Each film-coated tablet for oral use contains 50 mg of riluzole and the following inactive ingredients: dibasic calcium phosphate anhydrous, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, croscarmellose sodium, hypromellose, lactose monohydrate, titanium dioxide, triacetin, citric acid monohydrate. Chemical Structure

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