Nizatidine 150 mg Capsule, 36,000-count
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- 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
Where does this data come from?
🧪 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 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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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.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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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 XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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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 WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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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.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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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 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.
14 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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nizatidine 150 mgthis 00591-3137-00 | Actavis | 36000 capsules | — | — | FDA listed | — |
| Nizatidine 150 mg 42806-0299-30 | Epic | 30 capsules | — | AB | FDA listed | — |
| Nizatidine 150 mg 55111-0310-01 | Dr | 100 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00591-3137-60 | 60 CAPSULE in 1 BOTTLE, PLASTIC (0591-3137-60) | $0.8053 / ea | $48.32 | 2002-07-09 | Active |
| 00591-3137-00 You're viewing this | 36000 CAPSULE in 1 BAG (0591-3137-00) | — | — | — | Active |
| 00591-3137-77 | 17795 CAPSULE in 1 CONTAINER (0591-3137-77) | — | — | — | Active |
You're viewing the largest of 3 pack sizes for this product.
This pack shows little to no recent Medicaid volume — the 60 capsules pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 00591-3137-00?
What is the difference between NDC 00591-3137-00 and NDC 00591-3137-60?
What NDC number is used to bill for this package of Nizatidine 150 mg Capsule?
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
What "drug for further processing" means
FDA lists this package under the "drug for further processing" marketing category: Actavis Pharma, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.
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
Is this NDC FDA-approved?
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Where does this data come from?
📄 Full FDA label FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Nizatidine 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 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 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 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.
⏱️ 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.
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 C cr Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy C cr Dose 20-50 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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 5 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 nondrug factors to the side effect incidence rate in the population studied. Table 5.
Incidence of Treatment-Emergent Adverse Events in Placebo-Controlled Clinical Trials In The United States and Canada Percentage of Patients Reporting Event Body System/Adverse Event * Nizatidine (N=2,694) Placebo (N=1,729) Body as a Whole Headache 16.6
15.6Abdominal pain 7.5
12.5Pain 4.2
3.8Asthenia 3.1
2.9Back pain 2.4
2.6Chest pain 2.3
2.1Infection 1.7
1.1Fever 1.6
2.3Surgical procedure 1.4
1.5Injury, accident 1.2
0.9Digestive Diarrhea 7.2
6.9Nausea 5.4
7.4Flatulence 4.9
5.4Vomiting 3.6
5.6Dyspepsia 3.6
4.4Constipation 2.5
3.8Dry mouth 1.4
1.3Nausea and vomiting 1.2
1.9Anorexia 1.2
1.6Gastrointestinal disorder 1.1
1.2Tooth disorder 1.0
0.8Musculoskeletal Myalgia 1.7
1.5Nervous Dizziness 4.6
3.8Insomnia 2.7
3.4Abnormal dreams 1.9
1.9Somnolence 1.9
1.6Anxiety 1.6
1.4Nervousness 1.1
0.8Respiratory Rhinitis 9.8
9.6Pharyngitis 3.3
3.1Sinusitis 2.4
2.1Cough, increased 2.0
2.0Skin and Appendages Rash 1.9
2.1Pruritus 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 anti-androgenic 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-…
🆘 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.
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 Nizatidine is a competitive, reversible inhibitor of histamine at the histamine H2-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 : Nizatidine had no effect on basal serum gastrin.
No rebound of gastrin secretion was observed when food was ingested 12 hours after administration of nizatidine. 3. Other Pharmacologic Actions Hormones : Nizatidine was not shown to affect the serum concentrations of gonadotropins, prolactin, growth hormone, antidiuretic hormone, cortisol, triiodothyronine, thyroxin, testosterone, 5α-dihydrotestosterone, androstenedione, or estradiol.
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. A concentration of 1,000 mcg/L is equivalent to 3 mcmol/L; a dose of 300 mg is equivalent to 905 mcmoles. 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 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 oral 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…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Nizatidine capsules, USP are available as follows: 150 mg - Size #2, two-piece hard-gelatin buff opaque capsules imprinted “ 3137 ” on cap and “ WPI ” on body. Capsules are supplied in bottles of 60 (NDC 0591-3137-60). 300 mg - Size #0, two-piece hard-gelatin light brown opaque capsules imprinted with “ 3138 ” on cap and “ WPI ” on body.
Capsules are supplied in bottles of 30 (NDC 0591-3138-30). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 6/2022
📋 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 represented below: It is an off-white to buff crystalline solid that is soluble in water.
Nizatidine, USP has a bitter taste and mild sulfur-like odor. Nizatidine capsules USP, for oral administration, contain 150 mg or 300 mg nizatidine, USP and the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate and pregelatinized starch. The capsule shells contain: ammonium hydroxide, black iron oxide, gelatin, potassium hydroxide, propylene glycol, shellac, silicon dioxide, sodium lauryl sulfate and titanium dioxide.
The 150 mg capsule shell also contains D&C Yellow No. 10 and FD&C Yellow No. 6.
The 300 mg capsule shell also contains black iron oxide, red iron oxide and yellow iron oxide. Image