NIZATIDINE 15 mg/mL Solution, 480 mL
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Histamine-2 Receptor Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Nizatidine is used to treat and prevent the recurrence of ulcers and to treat other conditions where the stomach makes too much acid. Nizatidine also is used to treat or prevent occasional heartburn, acid indigestion, or sour stomach. It decreases the amount of acid made in the stomach. Nizatidine is available with and without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗- Nizatidine is used to treat ulcers in the stomach and small intestine, and to manage acid reflux disease (GERD) — including when acid has caused actual damage or inflammation in th...
- Your stomach has special cells that release acid when a chemical called histamine tells them to. Nizatidine blocks the histamine 'switch' on those cells — called H2 receptors — so...
- You can take nizatidine with or without food — it doesn't make a big difference either way. One thing to avoid: if you're taking the capsule form, don't mix or dissolve it in apple...
- Can I take nizatidine with food, or does it have to be on an empty stomach?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Nizatidine — tap one for details:
Nizatidine may be associated with lower levels of 6 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 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 XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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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.
11 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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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 mL | 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nizatidine 15 mg/mLthis 60846-0301-15 | Amneal | 480 ml | — | — | 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)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 60846-0301-15 You're viewing this | 480 mL in 1 BOTTLE (60846-301-15) | 2016-08-12 | Active |
🧭 About this NDC listing & data coverage
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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| 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. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
Indications and Usage: Nizatidine oral solution is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Nizatidine oral solution is indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer.
The consequences of continuous therapy with nizatidine for longer than 1 year are not known. Nizatidine oral solution is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD. Nizatidine oral solution is indicated for up to 8 weeks for the treatment of active benign gastric ulcer.
Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration. In pediatric patients, nizatidine oral solution is indicated for ages 12 years and older. Nizatidine oral solution is indicated for up to 8 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.
⏱️ Dosage and Administration ▾
Dosage and Administration: Active Duodenal Ulcer —The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily. Maintenance of Healed Duodenal Ulcer —The recommended oral dosage for adults is 150 mg once daily at bedtime.
Gastroesophageal Reflux Disease —The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily. Active Benign Gastric Ulcer —The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.
Each mL of nizatidine oral solution contains 15 mg of nizatidine. In adults, nizatidine oral solution may be substituted for any of the above indications using equivalent doses of the oral solution. Pediatric Dosing— Each mL of oral solution contains 15 mg of nizatidine.
Nizatidine oral solution is indicated for pediatric patients 12 years of age or older. For pediatric patients 12 years of age and older, the dosage of nizatidine is 150 mg b.i.d. (2 tsp, b.i.d.) The following dosage recommendations are provided: Erosive Esophagitis —For pediatric patients 12 years or older, the dosage is 150 mg b.i.d.
(300 mg/d). The maximum daily dose for nizatidine PO is 300 mg/d. The dosing duration may be up to eight weeks.
Gastroesophageal Reflux Disease — For pediatric patients 12 years or older, the dosage is 150 mg b.i.d. (300 mg/d). The maximum daily dose for nizatidine PO is 300 mg/d.
The dosing duration may be up to eight weeks. Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency —The dose for patients with renal dysfunction should be reduced as follows: Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer Creatinine Clearance Dose 20 to 50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Creatinine Clearance Dose 20 to 50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly.
The clinical effects of this dosage reduction in patients with renal failure have not been evaluated. Based on the pharmacokinetic data in elderly patients with renal impairment, pediatric patients with creatinine clearances less than 50 mL/min, should have their dose of nizatidine reduced accordingly. The clinical effects of this dose reduction in pediatric patients with renal failure have not been evaluated.
⛔ Contraindications ▾
Contraindication: Nizatidine oral solution is contraindicated in patients with known hypersensitivity to the drug. Because cross-sensitivity in this class of compounds has been observed, H 2 -receptor antagonists, including nizatidine, should not be administered to patients with a history of hypersensitivity to other H 2 -receptor antagonists.
🤒 Adverse Reactions ▾
Adverse Reactions in Adults: Worldwide, controlled clinical trials of nizatidine included over 6,000 patients given nizatidine in studies of varying durations. Placebo-controlled trials in the United States and Canada included over 2,600 patients given nizatidine and over 1,700 given placebo. Among the adverse events in these placebo-controlled trials, anemia (0.2% vs 0%) and urticaria (0.5% vs 0.1%) were significantly more common in the nizatidine group.
Incidence in Placebo-Controlled Clinical Trials in the United States and Canada —Table 7 lists adverse events that occurred at a frequency of 1% or more among nizatidine-treated patients who participated in placebo-controlled trials. The cited figures provide some basis for estimating the relative contribution of drug and non-drug factors to the side-effect incidence rate in the population studied. Table 7.
Incidence of Treatment-Emergent Adverse Events in Placebo-Controlled Clinical Trials in the United States and Canada Percentage of Patients Reporting Event Percentage of Patients Reporting Event Body System/ Adverse Event* Nizatidine (N=2,694) Placebo (N=1,729) Body System/ Adverse Event* Nizatidine (N=2,694) Placebo (N=1,729) Body as a Whole Nervous Headache 16.6
15.6Dizziness 4.6
3.8Pain 4.2
3.8Insomnia 2.7
3.4Asthenia 3.1
2.9Abnormal dreams 1.9
1.9Chest pain 2.3
2.1Somnolence 1.9
1.6Infection 1.7
1.1Anxiety 1.8
1.4Injury, accident 1.2
0.9Nervousness 1.1
0.8Digestive Respiratory Diarrhea 7.2
6.9Rhinitis 9.8
9.6Dry mouth 1.4
1.3Pharyngitis 3.3
3.1Tooth disorder 1.0
0.8Sinusitis 2.4
2.1Musculoskeletal Cough, increased 2.0
2.0Myalgia 1.7
1.5Skin and Appendages Rash 1.9
2.1Pruritis 1.7
1.3Special Senses Amblyopia 1.0 0.9 *Events reported by at least 1% of nizatidine–treated patients are included. A variety of less common events were also reported; it was not possible to determine whether these were caused by nizatidine. Hepatic —Hepatocellular injury, evidenced by elevated liver enzyme tests (SGOT [AST], SGPT [ALT], or alkaline phosphatase), occurred in some patients and was possibly or probably related to nizatidine.
In some cases, there was marked elevation of SGOT, SGPT enzymes (greater than 500 IU/L) and, in a single instance, SGPT was greater than 2,000 IU/L. The overall rate of occurrences of elevated liver enzymes and elevations to 3 times the upper limit of normal, however, did not significantly differ from the rate of liver enzyme abnormalities in placebo-treated patients. All abnormalities were reversible after discontinuation of nizatidine.
Since market introduction, hepatitis and jaundice have been reported. Rare cases of cholestatic or mixed hepatocellular and cholestatic injury with jaundice have been reported with reversal of the abnormalities after discontinuation of nizatidine. Cardiovascular —In clinical pharmacology studies, short episodes of asymptomatic ventricular tachycardia occurred in 2 individuals administered nizatidine and in 3 untreated subjects.
CNS— Rare cases of reversible mental confusion have been reported. Endocrine —Clinical pharmacology studies and controlled clinical trials showed no evidence of antiandrogenic activity due to nizatidine. Impotence and decreased libido were reported with similar frequency by patients who received nizatidine and by those given placebo.
Rare reports of gynecomastia occurred. Hematologic —Anemia was reported significantly more frequently in nizatidine- than in placebo-treated patients. Fatal thrombocytopenia was reported in a patient who was treated with nizatidine and another H 2 -receptor antagonist.
On previous occasions, this patient had experienced thrombocytopenia while taking other drugs. Rare cases of thrombocytopenic purpura have been reported. Integumental —Sweating and urticaria were reported significantly more frequently in nizatidine- than in placebo-treated patients.
Rash and exfoliative dermatitis were also reported. Vasculitis has been reported rarely. Hypersensitivity —…
🆘 Overdosage ▾
Overdosage: Overdoses of nizatidine have been reported rarely. The following is provided to serve as a guide should such an overdose be encountered. Signs and Symptoms —There is little clinical experience with overdosage of nizatidine in humans.
Test animals that received large doses of nizatidine have exhibited cholinergic-type effects, including lacrimation, salivation, emesis, miosis, and diarrhea. Single oral doses of 800 mg/kg in dogs and of 1,200 mg/kg in monkeys were not lethal. Intravenous median lethal doses in the rat and mouse were 301 mg/kg and 232 mg/kg respectively.
In the two 8-week pediatric exposure trials of nizatidine in 256 pediatric patients, there were no cases of deliberate overdosage. In one study of nizatidine 10 mg/kg/day, drug compliance rates up to 7.5% above 100% compliance were not associated with clinically significant adverse events. Treatment—To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center.
Telephone numbers of certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. If overdosage occurs, use of activated charcoal, emesis, or lavage should be considered along with clinical monitoring and supportive therapy.
The ability of hemodialysis to remove nizatidine from the body has not been conclusively demonstrated; however, due to its large volume of distribution, nizatidine is not expected to be efficiently removed from the body by this method.
🧬 Clinical Pharmacology ▾
Clinical Pharmacology in Adults: Nizatidine is a competitive, reversible inhibitor of histamine at the histamine H 2 -receptors, particularly those in the gastric parietal cells. Antisecretory Activity —1. Effects on Acid Secretion : Nizatidine significantly inhibited nocturnal gastric acid secretion for up to 12 hours.
Nizatidine also significantly inhibited gastric acid secretion stimulated by food, caffeine, betazole, and pentagastrin (Table 1). Table 1. Effect of Oral Nizatidine on Gastric Acid Secretion Time After Dose (h) % Inhibition of Gastric Acid Output by Dose (mg) 20 to 50 75 100 150 300 Nocturnal Up to 10 57 - 73 - 90 Betazole Up to 3 - 93 - 100 99 Pentagastrin Up to 6 - 25 - 64 67 Meal Up to 4 41 64 - 98 97 Caffeine Up to 3 - 73 - 85 96 2.
Effects on Other Gastrointestinal Secretions — Pepsin : Oral administration of 75 to 300 mg of nizatidine did not affect pepsin activity in gastric secretions. Total pepsin output was reduced in proportion to the reduced volume of gastric secretions. Intrinsic Factor : Oral administration of 75 to 300 mg of nizatidine increased betazole-stimulated secretion of intrinsic factor.
Serum Gastrin Concentration : Nizatidine had no effect on basal serum gastrin concentration. No rebound of gastrin secretion was observed when food was ingested 12 hours after administration of nizatidine. 3.
Other Pharmacologic Actions — a. Hormones : Nizatidine was not shown to affect the serum concentrations of gonadotropins, prolactin, growth hormone, antidiuretic hormone, cortisol, triiodo-thyronine, thyroxin, testosterone, 5 α-dihydro-testosterone, androstenedione, or estradiol. b. Nizatidine had no demonstrable antiandrogenic action.
4. Pharmacokinetics —The absolute oral bioavailability of nizatidine exceeds 70%. Peak plasma concentrations (700 to 1,800 mcg/L for a 150 mg dose and 1,400 to 3,600 mcg/L for a 300 mg dose) occur from 0.5 to 3 hours following the dose.
Plasma concentrations 12 hours after administration are less than 10 mcg/L. The elimination half-life is 1 to 2 hours, plasma clearance is 40 to 60 L/h, and the volume of distribution is 0.8 to
1.5L/kg. Because of the short half-life and rapid clearance of nizatidine, accumulation of the drug would not be expected in individuals with normal renal function who take either 300 mg once daily at bedtime or 150 mg twice daily. Nizatidine exhibits dose proportionality over the recommended dose range.
The oral bioavailability of nizatidine is unaffected by concomitant ingestion of the anticholinergic propantheline. Antacids consisting of aluminum and magnesium hydroxides with simethicone decrease the absorption of nizatidine by about 10%. With food, the AUC and C max increase by approximately 10%.
In humans, less than 7% of an oral dose is metabolized as N2-monodesmethylnizatidine, an H 2 -receptor antagonist, which is the principal metabolite excreted in the urine. Other likely metabolites are the N2-oxide (less than 5% of the dose) and the S-oxide (less than 6% of the dose). More than 90% of an orally administered dose of nizatidine is excreted in the urine within 12 hours.
About 60% of an oral dose is excreted as unchanged drug. Renal clearance is about 500 mL/min, which indicates excretion by active tubular secretion. Less than 6% of an administered dose is eliminated in the feces.
Moderate to severe renal impairment significantly prolongs the half-life and decreases the clearance of nizatidine. In individuals who are functionally anephric, the half-life is 3.5 to 11 hours, and the plasma clearance is 7 to 14 L/h. To avoid accumulation of the drug in individuals with clinically significant renal impairment, the amount and/or frequency of doses of nizatidine should be reduced in proportion to the severity of dysfunction (see Dosage and Administration ).
Approximately 35% of nizatidine is bound to plasma protein, mainly to α 1 -acid glycoprotein. Warfarin, diazepam, acetaminophen, propantheline, phenobarbital, and propranolol did not affec…
📦 How Supplied / Storage and Handling ▾
How Supplied: Nizatidine Oral Solution 15 mg/mL is a clear, pale-yellow, peppermint flavored solution, available as Bottles of 480 mL – NDC 60846-301-15 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN Rx only Distributed by: Amneal Specialty, a division of Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev.
02-2021-01
📋 Description ▾
Description: Nizatidine (USP) is a histamine H 2 -receptor antagonist. Chemically, it is N-[2-[[[2-[(dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N ' -methyl-2-nitro-1,1-ethenediamine. The structural formula is as follows: Nizatidine has the empirical formula C 12 H 21 N 5 O 2 S 2 representing a molecular weight of 331.47.
It is an off-white to buff crystalline solid that is soluble in water. Nizatidine has a bitter taste and mild sulfur-like odor. Nizatidine oral solution is a clear, pale-yellow, peppermint flavored solution and each 1 mL contains 15 mg of nizatidine.
Nizatidine oral solution also contains the inactive ingredients anhydrous citric acid, glycerin, magnasweet, methylparaben, natural peppermint extract, povidone, propylparaben, purified water, saccharin sodium, sodium chloride, sodium citrate, sucrose and xanthan gum. nizatidine image