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Nitazoxanide 500 mg Tablet, Film Coated, 30-count — NDC 64980-0526-03 package photo

Nitazoxanide 500 mg Tablet, Film Coated, 30-count

by Rising Pharma Holdings, Inc. · 30 TABLET, FILM COATED in 1 BOTTLE (64980-526-03)
NDC 64980-0526-03
🏷️ FDA NDC (as labeled) 64980-526-03 billing pads the product segment with a zero
This package
Contains30-count Pack sizes4 compare ↓
Also priced by: Part D plans $99.55/unit — full pricing hub ↓
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) 64980-526-03
Product NDC 64980-526
11-digit billing NDC 64980052603
NCPDP billing unit EA — each (per item)
RxCUI 427163
UNII SOA12P041N
UPC 0364980526036
Application # ANDA213820
SPL Set ID c0dc0656-3c46-43f9-adea-5285c522cef8
Established class (EPC) Antiprotozoal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-11-27
Route ORAL
Dosage form TABLET, FILM COATED
Substance NITAZOXANIDE
GPI-14 16400060000330
GPI class Nitazoxanide
GCN Seq No 029984
GCN 42761
HICL code 013845
Ingredient (HICL) Nitazoxanide
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W4
Therapeutic class — intermediate (HIC2) Antiparasitics
HIC3 code W4M
Therapeutic class — specific (HIC3) Antiparasitics
AHFS code 08:30.20.00
AHFS class Antiprotozoals, Cryptosporidiosis
FDB label name NITAZOXANIDE 500 MG TABLET
FDB brand name Nitazoxanide
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 64980-526-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 64980-0526-03. 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 Antiprotozoal class.

Pharmacologic class Antiprotozoal
Drug family (ATC) Other agents against amoebiasis and other protozoal diseases
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

LabelerRising Pharma Holdings, Inc.
Application holderRISING PHARMA HOLDINGS INC
FDA applicationANDA213820 (ANDA)
Labeler code64980
First marketedNov 2020
Product typeHuman Prescription Drug
Portfolio525 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name NITAZOXANIDE 500 MG TABLET Ingredient Nitazoxanide
📖 What it is MedlinePlus · NLM

Nitazoxanide is used to treat diarrhea in adults and children older than 1 year of age caused by the protozoa Cryptosporidium or Giardia. Protozoa are suspected as the cause when diarrhea lasts more than 7 days. Nitazoxanide is in a class of medications called antiprotozoal agents. It works by stopping the growth of certain protozoa that cause diarrhea.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats diarrhea caused by two specific intestinal parasites — Giardia lamblia and Cryptosporidium parvum. It's not a general antibiotic for all kinds of diarrhea. If your diarrh...
  • Yes, taking it with food is genuinely important — not just a suggestion. Food significantly increases how much of the active drug your body actually absorbs, which is what makes it...
  • Do I really have to take this with food? What if I forget?
  • That's actually a known and documented side effect called chromaturia — urine discoloration. It's been seen in clinical trials and is generally not dangerous. It should go away whe...
📖 Read our full Nitazoxanide 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 Yellow
ShapeRound
ImprintSUVEN;500
Size13 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 288VBX44JC
    Hypromellose is a plant-based cellulose derivative that acts as a binder and film-coating agent in medications. It helps hold tablet ingredients together and creates a smooth, protective coating on pills.
  • 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 AG9B65PV6B
    A starch derivative made from corn that helps tablets and capsules break apart quickly when swallowed. It acts as a disintegrant, allowing the medicine to dissolve and be absorbed in your stomach and intestines.
  • 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.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

5 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 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 $99.55 $2,986.56 / 30 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nitazoxanide 500 mg 70954-0934-10 ANI 6 tablets $86.976 AB Availability likely
Nitazoxanide 500 mg 13517-0135-06 e5 6 tablets AB FDA listed
Nitazoxanide 500 mg 31722-0100-30 Camber 30 tablets AB FDA listed
Nitazoxanide 500 mgthis 64980-0526-03 Rising 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

🏛️
2020
On the market since
Nov 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.

💊 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.
6 tablets64980-0526-60 320 Rx · $378,836
12 tablets64980-0526-21 No Medicaid data
18 tablets64980-0526-81 No Medicaid data
Drug total (last 4 qtrs): 320 Rx · 4,312 units · $378,836 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 Nitazoxanide — the program that covers self-administered drugs. 2 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 Nitazoxanide. 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
$821.7K
Claims incl. refills
702
Beneficiaries
591
Spend / beneficiary
$1,390.41
Spend / claim
$1,170.56
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 Per unit Per pack Marketing startStatus
64980-0526-03 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (64980-526-03) 2020-11-27 Active
64980-0526-21 12 TABLET, FILM COATED in 1 BOTTLE (64980-526-21) 2020-11-27 Active
64980-0526-60 6 TABLET, FILM COATED in 1 BOTTLE (64980-526-60) $86.98 / ea $521.86 2020-11-27 Active
64980-0526-81 18 TABLET, FILM COATED in 1 BOTTLE (64980-526-81) $86.89 / ea $1,563.99 2020-11-27 Active

You're viewing the largest of 4 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 6 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 64980-0526-03?
NDC 64980-0526-03 is a 30-count package — 30 tablet, film coated in 1 bottle.
What is the difference between NDC 64980-0526-03 and NDC 64980-0526-60?
Both are Nitazoxanide 500 mg Tablet, Film Coated — the drug itself is identical. NDC 64980-0526-03 is the 30-count package, while NDC 64980-0526-60 is the 6 tablets package.
What NDC number is used to bill for this package of Nitazoxanide 500 mg Tablet, Film Coated?
Bill NDC 64980-0526-03 — the 11-digit billing format is 64980052603. 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.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 64980-526-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 64980-0526-03, written without dashes as 64980052603. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 64980-0526-03, the first segment (64980) is the labeler code FDA assigned to Rising Pharma Holdings, Inc.; the middle segment (0526) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Rising Pharma Holdings, Inc.. 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 3 other package presentations of this same product, including 6 tablets (64980-0526-60), 12 tablets (64980-0526-21), 18 tablets (64980-0526-81). 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?
Rising Pharma Holdings, Inc. 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.

📄 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 110 words

1 INDICATIONS AND USAGE Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2) ]. Nitazoxanide tablets are antiprotozoal indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum (1).

Limitations of Use: Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by C. parvum in HIV-infected or immunodeficient patients (1) .

⏱️ Dosage and Administration 135 words

2 DOSAGE AND ADMINISTRATION • Nitazoxanide tablets should not be administered to pediatric patient 11 years of age or younger (2.1). • Dosage for treatment of diarrhea caused by G. lamblia or C. parvum (2.1) : Age Dosage Duration 12 years and older One nitazoxanide tablet (500 mg nitazoxanide) every 12 hours with food 3 days

2.1Recommended Dosage and Important Administration Instructions Important Administration Instructions for Pediatric Patients 11 years of Age or Younger: Nitazoxanide tablets should not be administered to pediatric patients 11 years of age or younger because a single tablet contains a greater amount of nitazoxanide than the recommended dosing in this pediatric age group. Table 1. Recommended Dosage Age Dosage Duration 12 years and older One Nitazoxanide tablet (500 mg nitazoxanide) taken orally every 12 hours with food 3 days

💊 Dosage Forms and Strengths 41 words

3 DOSAGE FORMS AND STRENGTHS • Nitazoxanide tablets: 500 mg (3.1)

3.1Nitazoxanide Tablets (500 mg) Round, yellow colored film coated tablet, debossed with “SUVEN” on one side and “500” on the other side. Each tablet contains 500 mg of nitazoxanide.

Contraindications 25 words

4 CONTRAINDICATIONS Hypersensitivity (4.1)

4.1Hypersensitivity Nitazoxanide tablets are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.

🤒 Adverse Reactions ~1 min read

6 ADVERSE REACTIONS The most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia, and nausea (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical 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. The safety of nitazoxanide was evaluated in 2177 HIV-uninfected subjects 12 months of age and older who received nitazoxanide tablets or nitazoxanide for oral suspension at the recommended dose for at least three days. In pooled controlled clinical trials involving 536 HIV-uninfected subjects treated with nitazoxanide tablets or nitazoxanide for oral suspension, the most common adverse reactions were abdominal pain, headache, chromaturia and nausea (≥2%).

Safety data were analyzed separately for 280 HIV-uninfected subjects ≥12 years of age receiving nitazoxanide at the recommended dose for at least three days in 5 placebo-controlled clinical trials and for 256 HIV-uninfected subjects 1 through 11 years of age in 7 controlled clinical trials. There were no differences between the adverse reactions reported for nitazoxanide-treated subjects based upon age.

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of nitazoxanide. 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. The following is a list of adverse reactions spontaneously reported with nitazoxanide tablets which were not included in clinical trial listings: Gastrointestinal disorders: diarrhea, gastroesophageal reflux disease Nervous System disorders: dizziness Respiratory, thoracic and mediastinal disorders: dyspnea Skin and subcutaneous tissue disorders: rash, urticaria

🔄 Drug Interactions 78 words

7 DRUG INTERACTIONS Competition for binding sites may occur when administered concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices. Monitor for adverse reactions (7) .

7.1Highly Protein Bound Drugs with Narrow Therapeutic Indices Tizoxanide (the active metabolite of nitazoxanide) is highly bound to plasma protein (>99.9%). Therefore, monitor for adverse reactions when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g., warfarin).

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS Pediatric Patients: Safety and efficacy of ALINIA for Oral Suspension in pediatric patients less than one year of age has not been studied ( 8.4 ).

8.1Pregnancy Risk Summary There are no data with nitazoxanide in pregnant women to inform a drug-associated risk. No teratogenicity or fetotoxicity was observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposures 30 and 2 times, respectively, the exposure at the maximum recommended human dose of 500 mg twice daily based on body surface area (BSA). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data Nitazoxanide was administered orally to pregnant rats at doses of 0, 200, 800 or 3200 mg/kg/day on gestation days 6 to 15. Nitazoxanide produced no evidence of systemic maternal toxicity when administered once daily via oral gavage to pregnant female rats at levels up to 3200 mg/kg/day during the period of organogenesis. In rabbits, nitazoxanide was administered at doses of 0, 25, 50, or 100 mg/kg/day on gestation days 7 to 20.

Oral treatment of pregnant rabbits with nitazoxanide during organogenesis resulted in minimal maternal toxicity and no external fetal anomalies.

8.2Lactation Risk Summary No information regarding the presence of nitazoxanide in human milk, the effects on the breastfed infant, or the effects on milk production is available. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for nitazoxanide and any potential adverse effects on the breastfed infant from nitazoxanide or from the underlying maternal condition.

8.4Pediatric Use The safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 1 to 11 years of age has been established based on three (3) randomized, controlled studies with 104 pediatric subjects treated with ALINIA for Oral Suspension 100 mg/5 mL. Furthermore, the safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on two (2) randomized controlled studies with 44 pediatric subjects treated with ALINIA for Oral Suspension 100 mg/5 mL. [ see Clinical Studies (14.1) ] The safety and efficacy of nitazoxanide tablets for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on three (3) randomized controlled studies with 47 pediatric subjects treated with nitazoxanide tablets 500 mg.

A single nitazoxanide tablet contains a greater amount of nitazoxanide than is recommended for use in pediatric patients 11 years or younger. [see Dosage and Administration (2.1) ]. Safety and efficacy of ALINIA for Oral Suspension in pediatric patients less than one year of age has not been studied.

8.5Geriatric Use Clinical studies of nitazoxanide tablets and Alinia for oral suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing nitazoxanide tablets and Alinia for oral suspension.

8.6Renal and Hepatic Impairment The pharmacokinetics of nitazoxanide in patients with compromised renal or hepatic function has not been studied.

8.7HIV-Infected or Immunodeficient Patients Nitazoxanide tablets and Alinia for oral suspension have not been studied for the treatment of diarrhea caused by G. lamblia in HIV-infected or immunodeficient patients. Nitazoxanide tablets and Alinia for oral suspension have not been shown to be…

🤰 Pregnancy 187 words

8.1Pregnancy Risk Summary There are no data with nitazoxanide in pregnant women to inform a drug-associated risk. No teratogenicity or fetotoxicity was observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposures 30 and 2 times, respectively, the exposure at the maximum recommended human dose of 500 mg twice daily based on body surface area (BSA). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data Nitazoxanide was administered orally to pregnant rats at doses of 0, 200, 800 or 3200 mg/kg/day on gestation days 6 to 15. Nitazoxanide produced no evidence of systemic maternal toxicity when administered once daily via oral gavage to pregnant female rats at levels up to 3200 mg/kg/day during the period of organogenesis. In rabbits, nitazoxanide was administered at doses of 0, 25, 50, or 100 mg/kg/day on gestation days 7 to 20.

Oral treatment of pregnant rabbits with nitazoxanide during organogenesis resulted in minimal maternal toxicity and no external fetal anomalies.

🧒 Pediatric Use 213 words

8.4Pediatric Use The safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 1 to 11 years of age has been established based on three (3) randomized, controlled studies with 104 pediatric subjects treated with ALINIA for Oral Suspension 100 mg/5 mL. Furthermore, the safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on two (2) randomized controlled studies with 44 pediatric subjects treated with ALINIA for Oral Suspension 100 mg/5 mL. [ see Clinical Studies (14.1) ] The safety and efficacy of nitazoxanide tablets for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on three (3) randomized controlled studies with 47 pediatric subjects treated with nitazoxanide tablets 500 mg.

A single nitazoxanide tablet contains a greater amount of nitazoxanide than is recommended for use in pediatric patients 11 years or younger. [see Dosage and Administration (2.1) ]. Safety and efficacy of ALINIA for Oral Suspension in pediatric patients less than one year of age has not been studied.

🧓 Geriatric Use 68 words

8.5Geriatric Use Clinical studies of nitazoxanide tablets and Alinia for oral suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing nitazoxanide tablets and Alinia for oral suspension.

🆘 Overdosage 60 words

10 OVERDOSAGE Limited information on nitazoxanide overdosage is available. In the event of overdose, gastric lavage may be appropriate soon after oral administration. Patients should be observed and given symptomatic and supportive treatment. There is no specific antidote for overdose with nitazoxanide. Because tizoxanide is highly protein bound (>99.9%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.

🧬 Clinical Pharmacology ~3 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Nitazoxanide is an antiprotozoal [see Microbiology (12.4) ].

12.3Pharmacokinetics Absorption Single Dosing: Following oral administration of nitazoxanide tablets or oral suspension, the parent drug, nitazoxanide, is not detected in plasma. The pharmacokinetic parameters of the metabolites, tizoxanide and tizoxanide glucuronide are shown in Tables 2 and 3 below. Table 2.

Mean (+/- SD) plasma pharmacokinetic parameters of tizoxanide and tizoxanide glucuronide following administration of a single dose of one 500 mg nitazoxanide tablet with food to subjects ≥12 years of age Tizoxanide Tizoxanide Glucuronide Age C max (μg/mL) *T max (hr) AUC ԏ (μg•hr/mL) C max (μg/mL) *T max (hr) AUC ԏ (μg•hr/mL) 12-17 years ≥18 years 9.1 (6.1) 10.6 (2.0) 4.0 (1-4) 3.0 (2-4) 39.5 (24.2) 41.9 (6.0) 7.3 (1.9) 10.5 (1.4) 4.0 (2-8) 4.5 (4-6) 46.5 (18.2) 63.0 (12.3) * T max is given as a Mean (Range) Table 3.

Mean (+/- SD) plasma pharmacokinetic of tizoxanide and tizoxanide glucuronide parameter values following administration of a single dose of nitazoxanide for oral suspension with food to subjects ≥1 year of age Tizoxanide Tizoxanide Glucuronide Age Dose C max (μg/mL) *T max (hr) AUC inf (μg•hr/mL) C max (μg/mL) *T max (hr) AUC inf (μg•hr/mL) 1-3 years 100 mg 3.11 (2.0) 3.5 (2-4) 11.7 (4.46) 3.64 (1.16) 4.0 (3-4) 19.0 (5.03) 4-11 years 200 mg 3.00 (0.99) 2.0 (1-4) 13.5 (3.3) 2.84 (0.97) 4.0 (2-4) 16.9 (5.00) ≥18 years 500 mg 5.49 (2.06) 2.5 (1-5) 30.2 (12.3) 3.21 (1.05) 4.0 (2.5-6) 22.8 (6.49) * T max is given as a Mean (Range) Multiple dosing: Following oral administration of a single nitazoxanide tablet every 12 hours for 7 consecutive days, there was no significant accumulation of nitazoxanide metabolites tizoxanide or tizoxanide glucuronide detected in plasma.

Bioavailability: Nitazoxanide for oral suspension is not bioequivalent to nitazoxanide tablets. The relative bioavailability of the suspension compared to the tablet was 70%. When nitazoxanide tablets are administered with food, the AUC ԏ of tizoxanide and tizoxanide glucuronide in plasma is increased almost two-fold and the C max is increased by almost 50%.

When nitazoxanide for oral suspension was administered with food, the AUC ԏ of tizoxanide and tizoxanide glucuronide increased by about 45-50% and the C max increased by ≤10%. Nitazoxanide tablets and nitazoxanide for oral suspension were administered with food in clinical trials and hence they are recommended to be administered with food [ see Dosage and Administration (2.1) ]. Distribution In plasma, more than 99% of tizoxanide is bound to proteins.

Elimination Metabolism Following oral administration in humans, nitazoxanide is rapidly hydrolyzed to an active metabolite, tizoxanide (desacetyl-nitazoxanide). Tizoxanide then undergoes conjugation, primarily by glucuronidation. Excretion Tizoxanide is excreted in the urine, bile and feces, and tizoxanide glucuronide is excreted in urine and bile.

Approximately two-thirds of the oral dose of nitazoxanide is excreted in the feces and one-third in the urine. Specific Populations Pediatric Patients The pharmacokinetics of tizoxanide and tizoxanide glucuronide following administration of nitazoxanide tablets in pediatric patients 12-17 years of age are provided above in Table 2.Mean (±SD) plasma pharmacokinetic parameters of tizoxanide and tizoxanide glucuronide following administraton of a single dose of one 500 mg Nitazoxanide Tablet with food to subject ≥12 years of age.

The pharmacokinetics of tizoxanide and tizoxanide glucuronide following administration of nitazoxanide for oral suspension in pediatric patients 1-11 years of age are provided above in Table 3. Mean (±SD) plasma pharmacokinetic of tizoxanide and tizoxanide glucuronide parameter values following administration of a single dose of ALINIA for Oral suspension with food to subjects ≥1 year of age. Drug Interaction Studies In vitro studies demonstrated that tizoxanide has no sig…

🧬 Mechanism of Action 12 words

12.1Mechanism of Action Nitazoxanide is an antiprotozoal [see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling 100 words

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1Nitazoxanide Tablets (500 mg) Nitazoxanide tablets are round, yellow colored film coated tablet, debossed with “SUVEN” on one side and “500” on the other side. Each tablet contains 500 mg of nitazoxanide. The tablets are packaged in HDPE bottles of 6, 12, 18 and 30 tablets.

Bottles of 6 tablets NDC 64980-526-60 Bottles of 12 tablets NDC 64980-526-21 Bottles of 18 tablets NDC 64980-526-81 Bottles of 30 tablets NDC 64980-526-03 Store the tablets at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

📋 Description 116 words

11 DESCRIPTION Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a pale yellow to yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water.

Chemically, nitazoxanide is 2-acetyloxy- N -(5-nitro-2-thiazolyl) benzamide. The molecular formula is C 12 H 9 N 3 O 5 S and the molecular weight is 307.3. The structural formula is: Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, partially pregelatinized maize starch, sodium starch glycolate, hypromellose, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No.

6 Aluminum Lake and FD&C Blue No.2 Aluminum Lake. nitazoxanide-structure.jpg

💬 Information for Patients 72 words

17 PATIENT COUNSELING INFORMATION Advise patients and parents/caregivers of pediatric patients taking nitazoxanide tablets of the following information: Dosage and Administration: Nitazoxanide tablets should be taken with food. Drug-drug Interactions: Avoid concurrent warfarin use. Manufactured for: Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816 ALINIA for Oral Suspension is distributed by Lupin Pharmaceuticals, Inc. under license from Romark. ALINIA is a registered trademark of Romark Neutral code: 4323147/TS/DRUGS/2025 Revised : 09/2025 PIR52603-05

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.