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Nizatidine 150 mg Capsule, 100-count — NDC 55111-0310-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nizatidine 150 mg Capsule, 100-count — NDC 55111-310-01 (Billing 55111-0310-01)

by Dr Reddy's Laboratories Limited · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Nizatidine 150 mg Capsule from Dr Reddy's Laboratories Limited, marketed since Sep 2005 and currently FDA-listed. It is the main listing for this product, which comes in 5 package sizes.

NDC 55111-0310-01
🏷️ FDA NDC (as labeled) 55111-310-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes5 compare ↓
Also priced by: Part D plans $1.17/unit — full pricing hub ↓
Main listing for product 55111-310 · Also comes in: 30 capsules 55111-310-30 60 capsules 55111-310-60 100 capsules 55111-310-78 500 capsules 55111-310-05
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55111-310-01
Product NDC 55111-310
11-digit billing NDC 55111031001
RxCUI 198041, 312025
UNII P41PML4GHR
Application # ANDA077314
SPL Set ID faaa7cc4-fda9-d5b8-de2a-71c8744ccb76
Established class (EPC) Histamine-2 Receptor Antagonist
Mechanism of action Histamine H2 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-09-15
Route ORAL
Dosage form CAPSULE
Substance NIZATIDINE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 011679
GCN 47710
HICL code 004522
Ingredient (HICL) Nizatidine
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2D
Therapeutic class — specific (HIC3) Histamine H2-Receptor Inhibitors
AHFS code 04:92.00.00
AHFS class Other Antihistamines
FDB label name NIZATIDINE 150 MG CAPSULE
FDB brand name Nizatidine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 011679
  • GCN: 47710
  • HICL (First Databank): 004522
  • AHFS class code: 04:92.00.00
  • RxCUI (RxNorm): 198041
Why two NDCs? The FDA registers this code as 55111-310-01 — 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 → 55111-0310-01. 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 Histamine-2 Receptor Antagonist class.

Pharmacologic class Histamine-2 Receptor Antagonist
Drug family (ATC) H2-receptor antagonists
How it works Histamine H2 Receptor Antagonists
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.

Clinical

Label name NIZATIDINE 150 MG CAPSULE Ingredient Nizatidine
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Nizatidine guide →
6
Nutrient depletion considerations

Nizatidine may be associated with lower levels of 6 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Nizatidine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

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 $1.17 $117.11 / 100 capsules
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55111-0310-01 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE 2005-09-15 — Active
55111-0310-05 55111-310-05 500 CAPSULE in 1 BOTTLE 2005-09-15 — Active
55111-0310-30 55111-310-30 30 CAPSULE in 1 BOTTLE 2005-09-15 — Active
55111-0310-60 55111-310-60 60 CAPSULE in 1 BOTTLE 2005-09-15 — Active
55111-0310-78 55111-310-78 10 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK 2005-09-15 — Active

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule in 1 bottle.
How does this package differ from NDC 55111-0310-30?
Both are Nizatidine 150 mg Capsule — the drug itself is identical. This page's package is the 100-count one, while NDC 55111-0310-30 is the 30 capsules package.
What NDC number is used to bill for this package of Nizatidine 150 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nizatidine 150 mg 00591-3137-60 Actavis 60 capsules $0.804 — Availability likely —
Nizatidine 150 mg 42806-0299-30 Epic 30 capsules — AB FDA listed —
Nizatidine 150 mgthis 55111-0310-01 Dr 100 capsules — 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

🏛️
2005
On the market since
Sep 2005
📍
2026
Currently FDA-listed
21 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.

What it looks like

Color Pink / Yellow / White
ShapeCapsule
ImprintRDY;311
Size19 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • 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.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

17 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 DailyMed — 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?
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.

Manufacturer & labeler

LabelerDr Reddy's Laboratories Limited
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA077314 (ANDA)
Labeler code55111
First marketedSep 2005
Product typeHuman Prescription Drug
Portfolio6 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 129 words ▾

INDICATIONS AND USAGE Nizatidine capsules are indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Nizatidine capsules are 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 capsules are 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 capsules are 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 220 words ▾

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.

⛔ Contraindications 47 words ▾

CONTRAINDICATION Nizatidine capsules are 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 ~3 min read ▾

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 Events reported by at least 1% of nizatidine-treated patients are included. 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

0.9A 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-tr… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 67 words ▾

Drug Interactions No interactions have been observed between nizatidine and theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin, and warfarin. Nizatidine does not inhibit the cytochrome P-450-linked drug-metabolizing enzyme system; therefore, drug interactions mediated by inhibition of hepatic metabolism are not expected to occur. In patients given very high doses (3,900 mg) of aspirin daily, increases in serum salicylate levels were seen when nizatidine, 150 mg b.i.d., was administered concurrently.

🤰 Pregnancy 106 words ▾

Pregnancy Teratogenic Effects Pregnancy category B Oral reproduction studies in pregnant rats at doses up to 1500 mg/kg/day (9000 mg/m 2 /day, 40.5 times the recommended human dose based on body surface area) and in pregnant rabbits at doses up to 275 mg/kg/day (3245 mg/m 2 /day, 14.6 times the recommended human dose based on body surface area) have revealed no evidence of impaired fertility or harm to the fetus due to nizatidine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 123 words ▾

Geriatric Use Of the 955 patients in clinical studies who were treated with nizatidine, 337 (35.3%) were 65 and older. No overall differences in safety or effectiveness were observed between these and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function ( see DOSAGE AND ADMINISTRATION ).

🆘 Overdosage 203 words ▾

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 ~3 min read ▾

CLINICAL PHARMACOLOGY 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) 20-50 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 a.

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. 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. A concentration of 1,000 mcg/L is equivalent to 3 µmol/L; a dose of 300 mg is equivalent to 905 µmoles.

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 affect pla… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling ~1 min read ▾

HOW SUPPLIED Nizatidine capsules, USP 150 mg are off white to buff colored granular powder filled in size '2' hard gelatin capsules with pink opaque cap and yellow opaque body, imprinted "RDY" on cap and "310" on body, with black ink and are supplied in bottles of 30's, 60's, 100's, 500's and unit dose package of 100 (10 × 10). Bottles of 30 NDC 55111-310-30 Bottles of 60 NDC 55111-310-60 Bottles of 100 NDC 55111-310-01 Bottles of 500 NDC 55111-310-05 Unit dose package of 100 (10 × 10 NDC 55111-310-78 Nizatidine capsules, USP 300 mg are off white to buff colored granular powder filled in size '1' hard gelatin capsules with opaque pink cap and white opaque body, imprinted "RDY" on cap and "311" on body, with black ink and are supplied in bottles of 30's, 60's, 100's, 500's and unit dose package of 100 (10 × 10).

Bottles of 30 NDC 55111-311-30 Bottles of 60 NDC 55111-311-60 Bottles of 100 NDC 55111-311-01 Bottles of 500 NDC 55111-311-05 Unit dose package of 100 (10 × 10) NDC 55111-311-78 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature] in a tightly closed light resistant container. The USP defines controlled room temperature as: A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.

📦 Storage and Handling 76 words ▾

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature] in a tightly closed light resistant container. The USP defines controlled room temperature as: A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.

📋 Description 192 words ▾

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 331.46.

It is an off white to buff crystalline solid that is soluble in water. Nizatidine has a bitter taste and mild sulfur-like odor. Each capsule contains for oral administration 150 mg (0.45 mmol) or 300 mg (0.91 mmol) of nizatidine and the following inactive ingredients: croscarmellose sodium, povidone, starch, dimethicone and talc.

The capsule shells contain D&C yellow no. 10, Titanium Dioxide, Gelatin, D&C red no. 28, FD&C blue no.

1, FD&C red no. 40 (for 150 mg) and Titanium Dioxide, Gelatin, D&C yellow no.10, FD&C blue no.1, FD&C red no. 40 (for 300 mg).

The imprinting ink contains Shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, FD&C blue no. 2, FD&C red no. 40, FD&C blue no.

1, D&C yellow no. 10, SDA 3A Alcohol (for 150 mg) and Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Strong Ammonia Solution, Black Iron Oxide, Potassium Hydroxide (for 300 mg). Structure

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Symptomatic response to nizatidine therapy does not preclude the presence of gastric malignancy. Because nizatidine is excreted primarily by the kidney, dosage should be reduced in patients with moderate to severe renal insufficiency ( see DOSAGE AND ADMINISTRATION ). Pharmacokinetic studies in patients with hepatorenal syndrome have not been done.

Part of the dose of nizatidine is metabolized in the liver. In patients with normal renal function and uncomplicated hepatic dysfunction, the disposition of nizatidine is similar to that in normal subjects. Laboratory Tests False-positive tests for urobilinogen with Multistix ® may occur during therapy with nizatidine.

Drug Interactions No interactions have been observed between nizatidine and theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin, and warfarin. Nizatidine does not inhibit the cytochrome P-450-linked drug-metabolizing enzyme system; therefore, drug interactions mediated by inhibition of hepatic metabolism are not expected to occur. In patients given very high doses (3,900 mg) of aspirin daily, increases in serum salicylate levels were seen when nizatidine, 150 mg b.i.d., was administered concurrently.

Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year oral carcinogenicity study in rats with doses as high as 500 mg/kg/day (about 80 times the recommended daily therapeutic dose) showed no evidence of a carcinogenic effect. There was a dose-related increase in the density of enterochromaffin-like (ECL) cells in the gastric oxyntic mucosa. In a 2-year study in mice, there was no evidence of a carcinogenic effect in male mice; although hyperplastic nodules of the liver were increased in the high-dose males as compared with placebo.

Female mice given the high dose of nizatidine (2,000 mg/kg/day, about 330 times the human dose) showed marginally statistically significant increases in hepatic carcinoma and hepatic nodular hyperplasia with no numerical increase seen in any of the other dose groups. The rate of hepatic carcinoma in the high-dose animals was within the historical control limits seen for the strain of mice used. The female mice were given a dose larger than the maximum tolerated dose, as indicated by excessive (30%) weight decrement as compared with concurrent controls and evidence of mild liver injury (transaminase elevations).

The occurrence of a marginal finding at high dose only in animals given an excessive and somewhat hepatotoxic dose, with no evidence of a carcinogenic effect in rats, male mice, and female mice (given up to 360 mg/kg/day, about 60 times the human dose), and a negative mutagenicity battery are not considered evidence of a carcinogenic potential for nizatidine. Nizatidine was not mutagenic in a battery of tests performed to evaluate its potential genetic toxicity, including bacterial mutation tests, unscheduled DNA synthesis, sister chromatid exchange, mouse lymphoma assay, chromosome aberration tests, and a micronucleus test.

In a 2-generation, perinatal and postnatal fertility study in rats, doses of nizatidine up to 650 mg/kg/day produced no adverse effects on the reproductive performance of parental animals or their progeny. Pregnancy Teratogenic Effects Pregnancy category B Oral reproduction studies in pregnant rats at doses up to 1500 mg/kg/day (9000 mg/m 2 /day, 40.5 times the recommended human dose based on body surface area) and in pregnant rabbits at doses up to 275 mg/kg/day (3245 mg/m 2 /day, 14.6 times the recommended human dose based on body surface area) have revealed no evidence of impaired fertility or harm to the fetus due to nizatidine.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Studies conducted in lactating women have shown that 0.1% of the administered oral dose of nizatidine is secr… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 66 words ▾

Nursing Mothers Studies conducted in lactating women have shown that 0.1% of the administered oral dose of nizatidine is secreted in human milk in proportion to plasma concentrations. Because of the growth depression in pups reared by lactating rats treated with nizatidine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics ~2 min read ▾

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 µmol/L; a dose of 300 mg is equivalent to 905 µmoles. 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 affect plasma protein binding of nizatidine in vitro.

🔬 Clinical Studies ~2 min read ▾

Clinical Trials 1. Active Duodenal Ulcer In multicenter, double-blind, placebo-controlled studies in the United States, endoscopically diagnosed duodenal ulcers healed more rapidly following administration of nizatidine, 300 mg h.s. or 150 mg b.i.d., than with placebo ( Table 2 ). Lower doses, such as 100 mg h.s., had slightly lower effectiveness.

Table 2.—Healing Response of Ulcers to Nizatidine Nizatidine Placebo 300 mg h.s. 150 mg b.i.d. Number Entered Healed/ Evaluable Number Entered Healed/ Evaluable Number Entered Healed/ Evaluable STUDY 1 Week 2 276 93/265 (35%) P <0.01 as compared with placebo.

279 55/260 (21%) Week 4 198/259 (76%) 95/243 (39%) STUDY 2 Week 2 108 24/103 (23%) 106 27/101 (27%) 101 9/93 (10%) Week 4 65/97 (67%) 66/97 (68%) 24/84 (29%) STUDY 3 Week 2 92 22/90 (24%) P <0.05 as compared with placebo. 98 13/92 (14%) Week 4 52/85 (61%) 29/88 (33%) Week 8 68/83 (82%) 39/79 (49%) 2. Maintenance of Healed Duodenal Ulcer Treatment with a reduced dose of nizatidine has been shown to be effective as maintenance therapy following healing of active duodenal ulcers.

In multicenter, double-blind, placebo-controlled studies conducted in the United States, 150 mg of nizatidine taken at bedtime resulted in a significantly lower incidence of duodenal ulcer recurrence in patients treated for up to 1 year ( Table 3 ). Table 3. Percentage of Ulcers Recurring by 3, 6, and 12 Months in Double-Blind Studies Conducted in the United States Month Nizatidine, 150 mg h.s.

Placebo 3 13% (28/208) P <0.001 as compared with placebo. 40% (82/204) 6 24% (45/188) 57% (106/187) 12 34% (57/166) 64% (112/175) 3. Gastroesophageal Reflux Disease (GERD) In 2 multicenter, double-blind, placebo-controlled clinical trials performed in the United States and Canada, nizatidine was more effective than placebo in improving endoscopically diagnosed esophagitis and in healing erosive and ulcerative esophagitis.

In patients with erosive or ulcerative esophagitis, 150 mg b.i.d. of nizatidine given to 88 patients compared with placebo in 98 patients in Study 1 yielded a higher healing rate at 3 weeks (16% vs 7%) and at 6 weeks (32% vs 16%, P <0.05). Of 99 patients on nizatidine and 94 patients on placebo, Study 2 at the same dosage yielded similar results at 6 weeks (21% vs 11%, P <0.05) and at 12 weeks (29% vs 13%, P <0.01). In addition, relief of associated heartburn was greater in patients treated with nizatidine.

Patients treated with nizatidine consumed fewer antacids than did patients treated with placebo. 4. Active Benign Gastric Ulcer In a multicenter, double-blind, placebo-controlled study conducted in the United States and Canada, endoscopically diagnosed benign gastric ulcers healed significantly more rapidly following administration of nizatidine than of placebo ( Table 4 ).

Table 4. Week Treatment Healing Rate vs. Placebo p-value P-values are one-sided, obtained by Chi-square test, and not adjusted for multiple comparisons.

4 Niz 300 mg h.s. 52/153 (34%) 0.342 Niz 150 mg b.i.d. 65/151 (43%) 0.022 Placebo 48/151 (32%) 8 Niz 300 mg h.s.

99/153 (65%) 0.011 Niz 150 mg b.i.d. 105/151 (70%) <0.001 Placebo 78/151 (52%) In a multicenter, double-blind, comparator-controlled study in Europe, healing rates for patients receiving nizatidine (300 mg h.s. or 150 mg b.i.d.) were equivalent to rates for patients receiving a comparator drug, and statistically superior to historical placebo control rates.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year oral carcinogenicity study in rats with doses as high as 500 mg/kg/day (about 80 times the recommended daily therapeutic dose) showed no evidence of a carcinogenic effect. There was a dose-related increase in the density of enterochromaffin-like (ECL) cells in the gastric oxyntic mucosa. In a 2-year study in mice, there was no evidence of a carcinogenic effect in male mice; although hyperplastic nodules of the liver were increased in the high-dose males as compared with placebo.

Female mice given the high dose of nizatidine (2,000 mg/kg/day, about 330 times the human dose) showed marginally statistically significant increases in hepatic carcinoma and hepatic nodular hyperplasia with no numerical increase seen in any of the other dose groups. The rate of hepatic carcinoma in the high-dose animals was within the historical control limits seen for the strain of mice used. The female mice were given a dose larger than the maximum tolerated dose, as indicated by excessive (30%) weight decrement as compared with concurrent controls and evidence of mild liver injury (transaminase elevations).

The occurrence of a marginal finding at high dose only in animals given an excessive and somewhat hepatotoxic dose, with no evidence of a carcinogenic effect in rats, male mice, and female mice (given up to 360 mg/kg/day, about 60 times the human dose), and a negative mutagenicity battery are not considered evidence of a carcinogenic potential for nizatidine. Nizatidine was not mutagenic in a battery of tests performed to evaluate its potential genetic toxicity, including bacterial mutation tests, unscheduled DNA synthesis, sister chromatid exchange, mouse lymphoma assay, chromosome aberration tests, and a micronucleus test.

In a 2-generation, perinatal and postnatal fertility study in rats, doses of nizatidine up to 650 mg/kg/day produced no adverse effects on the reproductive performance of parental animals or their progeny.

📄 Package Label / Principal Display Panel 14 words ▾

150 mg Labels Container labels

Carton labels

300 mg Labels Container labels

Carton labels

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

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

Medicare Part D (outpatient prescription) spending for Nizatidine — 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 Nizatidine. 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
$116.2K
Claims incl. refills
1.1K
Beneficiaries
816
Spend / beneficiary
$142.44
Spend / claim
$101.16
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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Dr Reddy's Laboratories Limited. 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 4 other package presentations of this same product, including 30 capsules (55111-0310-30), 60 capsules (55111-0310-60), 100 capsules (55111-0310-78). 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?
Dr Reddy's Laboratories Limited 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.
← 55111-0302-05 · Dr. 55111-0311-01 · Dr →
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.