Nitazoxanide 500 mg Tablet, Film Coated, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Antiprotozoal class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- 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...
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Supplement & herbal interactions
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💊 What it looks like
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🧪 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.
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UNII CQ3XH3DET6
D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII 36SFW2JZ0W
Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
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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.
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UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
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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.
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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.
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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.
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UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
12 inactive ingredients listed in the exact product block matched to this NDC.
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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
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💲 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 system | Per each | Per 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 |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 mgthis 31722-0100-30 | Camber | 30 tablets | — | AB | FDA listed | — |
| Nitazoxanide 500 mg 64980-0526-03 | Rising | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 31722-0100-30 You're viewing this | 1 BOTTLE in 1 CARTON (31722-100-30) / 30 TABLET, FILM COATED in 1 BOTTLE | — | — | 2025-04-15 | Active |
| 31722-0100-31 | 1 BOTTLE in 1 CARTON (31722-100-31) / 12 TABLET, FILM COATED in 1 BOTTLE | — | — | 2025-04-15 | Active |
| 31722-0100-32 | 1 BOTTLE in 1 CARTON (31722-100-32) / 6 TABLET, FILM COATED in 1 BOTTLE | $86.98 / ea | $521.86 | 2025-04-15 | Active |
Pack size FAQ
What quantity is in NDC 31722-0100-30?
What is the difference between NDC 31722-0100-30 and NDC 31722-0100-32?
What NDC number is used to bill for this package of Nitazoxanide 500 mg Tablet, Film Coated?
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
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| 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 | — Not published for this NDC No photo available yet for this listing. |
| 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. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
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 500 mg nitazoxanide tablet 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 500 mg nitazoxanide tablet taken orally every 12 hours with food 3 days
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Nitazoxanide tablets: 500 mg ( 3 ).
3.1Nitazoxanide Tablets (500 mg) Green colored, round biconvex film-coated tablets debossed with “V1” on one side and “1” on the other side. Each tablet contains 500 mg of nitazoxanide.
⛔ Contraindications ▾
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 ▾
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 Annora Pharma Private Limited at 1-866-495-1995 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 Alina 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 Alina 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 ▾
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 ▾
8 USE IN SPECIFIC POPULATIONS
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 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 )] .
8.5Geriatric Use Clinical studies of nitazoxanide tablets 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.
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 have not been studied for the treatment of diarrhea caused by G. lamblia in HIV-infected or immunodeficient patients. Nitazoxanide tablets have not been shown to be superior to placebo for the treatment of diarrhea caused by C. parvum in HIV-infected or immunodeficient patients [see Clinical Studies ( 14 )] .
🤰 Pregnancy ▾
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 ▾
8.4Pediatric Use 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 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of nitazoxanide tablets 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.
🆘 Overdosage ▾
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 ▾
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, 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 (mcg/mL) *T max (hr) AUC τ (mcg•hr/mL) C max (mcg/mL) *T max (hr) AUC τ (mcg•hr/mL) 12 to 7 years 9.1 (6.1) 4.0 (1 to 4) 39.5 (24.2) 7.3 (1.9) 4.0 (2 to 8) 46.5 (18.2) ≥18 years 10.6 (2.0) 3.0 (2 to 4) 41.9 (6.0) 10.5 (1.4) 4.5 (4 to 6) 63.0 (12.3) * 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: Alina 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 τ of tizoxanide and tizoxanide glucuronide in plasma is increased almost two-fold and the C max is increased by almost 50%.
Nitazoxanide tablets 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 to 17 years of age are provided above in Table 2. Mean (±SD) plasma pharmacokinetic parameters of tizoxanide and tizoxanide glcuronide following administration of a single dose of one 500 mg nitazoxanide tablet with food to subject ≥12 years of age. Drug Interaction Studies In vitro studies demonstrated that tizoxanide has no significant inhibitory effect on cytochrome P450 enzymes.
12.4Microbiology Mechanism of Action The antiprotozoal activity of nitazoxanide is believed to be due to interference with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction which is essential to anaerobic energy metabolism. Studies have shown that the PFOR enzyme from G. lamblia directly reduces nitazoxanide by transfer of electrons in the absence of ferredoxin. The DNA-derived PFOR protein sequence of C. parvum appears to be similar to that of G. lamblia .
Interference with the PFOR enzyme-dependent electron transfer reaction may not be the only pathway by which nitazoxanide exhibits antiprotozoal activity. Resistance A potential for development of resistance by C. parvum or G. lamblia to nitazoxanide has not been examined. Antimicrobial Activity Nitazoxanide and its metabolite, tizoxanide, are active in vitro in inhibiting the growth of (i) sporozoites and oocysts of C. parvum and (ii) trophozoites of G. lamblia.
Susceptibility Test Methods For protozoa such as C. parvum and G. lamblia , standardized tests for use in clinical microbiology laboratories are not available.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Nitazoxanide is an antiprotozoal [see Microbiology ( 12.4 )].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1Nitazoxanide Tablets (500 mg) Nitazoxanide tablets 500 mg are green colored, round biconvex film-coated tablets debossed with “V1” on one side and “1” on the other side. Each tablet contains 500 mg of nitazoxanide. The tablets are packaged in HDPE bottles of 6, 12 and 30 tablets.
Bottles of 12 tablets NDC 31722-100-31 Bottles of 30 tablets NDC 31722-100-30 Bottles of 6 tablets NDC 31722-100-32 Store the tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]
📋 Description ▾
11 DESCRIPTION Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is off-white to yellow powder. It is practically insoluble in ethanol, water and soluble in N, N-dimethylacetamide.
Chemically, nitazoxanide is 2-((5-Nitrothiazol-2-yl) carbamoyl) phenyl acetate. The molecular formula is C 12 H 9 N 3 O 5 S and the molecular weight is 307.28. The structural formula is: Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: corn starch, D&C yellow #10 aluminum lake, FD&C blue #2, FD&C yellow #6, hypromellose, lecithin (soya), magnesium stearate, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and xanthan gum. nitazoxanidetabletsstructure
💬 Information for Patients ▾
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: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Annora Pharma Pvt. Ltd. Sangareddy - 502313, Telangana, India. Revised: 05/2025 camberlogo