RANITIDINE 150 mg Tablet, 30-count
🆔 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
Ranitidine is used to treat ulcers; gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the food pipe (esophagus); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome. Over-the-counter ranitidine is used to prevent and treat symptoms of heartburn associated with acid indigestion and sour stomach. Ranitidine is in a class of medications called H2 blockers. It decreases the amount of acid made in the stomach.
Read the full MedlinePlus article ↗- Ranitidine works by turning down your stomach's acid production. Less acid means conditions like ulcers, acid reflux (GERD), and an inflamed esophagus can heal — and it also helps...
- What exactly is ranitidine supposed to do for me?
- You can take ranitidine with or without food — eating doesn't significantly affect how well your body absorbs it. For prescription use, just follow the schedule your doctor gave yo...
- Can I take this with food, or does it have to be on an empty stomach?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ranitidine — tap one for details:
Ranitidine may be associated with lower levels of 6 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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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 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 EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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UNII 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 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII 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.
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
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $4.42 | $132.73 / 30 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ranitidine 150 mgthis 64980-0636-03 | Rising | 30 tablets | — | AB | FDA listed | — |
| Ranitidine 150 mg 62207-0773-36 | Granules | 50000 tablets | — | — | FDA listed | — |
| Ranitidine 150 mg 55111-0404-02 | Dr. | 200 tablets | — | — | FDA listed | — |
| Ranitidine 150 mg 53746-0253-01 | Amneal | 100 tablets | — | — | FDA listed | — |
| Ranitidine cool mint 150 mg 62207-0774-36 | Granules | 50000 tablets | — | — | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 64980-0636-03 You're viewing this | 30 TABLET in 1 BOTTLE (64980-636-03) | 2025-12-06 | 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 | ✓ 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. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ranitidine Tablets are indicated in: Short- term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of Ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo- controlled comparative studies have been carried out for periods of longer than 1 year. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
Short-term treatment of active, benign gastric ulcers. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. Treatment of GERD.
Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets USP, 150 mg twice daily. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets USP, 150 mg 4 times daily.
Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks. Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Active Duodenal Ulcer: The current recommended adult oral dosage of Ranitidine Tablets for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared with the other in a particular patient population have yet to be demonstrated (see Clinical Trials: Active Duodenal Ulcer ).
Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US studies, and several foreign trials have shown that 100 mg twice daily is as effective as the 150 mg dose. Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics ). Maintenance of Healing of Duodenal Ulcers: The current recommended adult oral dosage is 150 mg at bedtime.
Pathological Hypersecretory Conditions (such as Zollinger - Ellison syndrome): The current recommended adult oral dosage is 150 mg twice daily. In some patients it may be necessary to administer Ranitidine Tablets USP, 150 mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated.
Dosages up to 6 g/day have been employed in patients with severe disease. Benign Gastric Ulcer: The current recommended adult oral dosage is 150 mg twice daily. Maintenance of Healing of Gastric Ulcers: The current recommended adult oral dosage is 150 mg at bedtime.
GERD: The current recommended adult oral dosage is 150 mg twice daily. Erosive Esophagitis: The current recommended adult oral dosage is 150 mg 4 times daily. Maintenance of Healing of Erosive Esophagitis: The current recommended adult oral dosage is 150 mg twice daily.
Pediatric Use: The safety and effectiveness of Ranitidine Tablets have been established in the age group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of Ranitidine Tablets in neonatal patients (less than 1 month of age) to make dosing recommendations. The following 3 subsections provide dosing information for each of the pediatric indications.
Treatment of Duodenal and Gastric Ulcers: The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendations is derived from adult clinical studies and pharmacokinetic data in pediatric patients. Maintenance of Healing of Duodenal and Gastric Ulcers : The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is to 2 to 4 mg/kg once daily to a maximum of 150 mg/day.
This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients. Treatment of GERD and Erosive Esophagitis: Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg/day, usually given as 2 divided doses. Dosage Adjustment for Patients with Impaired Renal Function: On the basis of experience with a group of subjects with severely impaired renal function treated with Ranitidine Tablets, the recommended dosage in patients with a creatinine clearance < 50 mL/min is 150 mg every 24 hours.
Should the patient’s condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.
Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics and PRECAUTIONS : Geriatric Use ).
⛔ Contraindications ▾
CONTRAINDICATIONS Ranitidine Tablets are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS ).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following have been reported as events in clinical trials or in the routine management of patients treated with Ranitidine Tablets. The relationship to therapy with Ranitidine Tablets has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of Ranitidine Tablets.
Central Nervous System: Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported.
Rare reports of reversible involuntary motor disturbances have been received. Cardiovascular: As with other H 2 -blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats. Gastrointestinal: Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis.
Hepatic: There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, ranitidine should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred.
Rare cases of hepatic failure have also been reported. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intravenously 4 times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously 4 times daily for 5 days. Musculoskeletal: Rare reports of arthralgias and myalgias.
Hematologic: Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with narrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.
Endocrine: Controlled studies in animals and man have shown no stimulation of any pituitary hormone by Ranitidine Tablets and no antiadrenogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when Ranitidine Tablets has been substituted. However, occasional cases of impotence and loss of libido have been reported in male patients receiving Ranitidine Tablets, but the incidence did not differ from that in the general population. Rare cases of breast symptoms and conditions, including galactorrhea and gynecomastia, have been reported in both males and females.
Integumentary: Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis. Respiratory: A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H 2 RAs) compared with patients who had stopped H 2 RA treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07-2.48).
However, a causal relationship between use of H 2 RAs and pneumonia has not been established. Other: Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🆘 Overdosage ▾
OVERDOSAGE There has been limited experience with overdosage. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience (see ADVERSE REACTIONS ). In addition, abnormalities of gait and hypotension have been reported.
When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed. Studies in dogs receiving dosages of Ranitidine, in excess of 225 mg/kg/day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal.
Intravenous LD 50 , values in mice and rats were 77 and 83 mg/kg, respectively.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Ranitidine Tablets are a competitive, reversible inhibitor of the action of histamine at the histamine H 2 -receptors, including receptors on the gastric cells. Ranitidine Tablets do not lower serum Ca++ in hypercalcemic states. Ranitidine Tablets are not an anticholinergic agent.
Pharmacokinetics Absorption: Ranitidine Tablets are 50% absorbed after oral administration, compared to an intravenous (IV) injection with mean peak levels of 440 to 545 ng/mL occurring 2 to 3 hours after a 150 mg dose. Absorption is not significantly impaired by the administration of food or antacids. Propantheline slightly delays and increases peak blood levels of ranitidine, probably by delaying gastric emptying and transit time.
In one study, simultaneous administration of high-potency antacid (150 mmol) in fasting subjects has been reported to decrease the absorption of Ranitidine Tablets. Distribution: The volume of distribution is about
1.4L/kg. Serum protein binding averages 15%. Metabolism: In humans, the N-oxide is the principal metabolite in the urine; however, this amounts to < 4% of the dose.
Other metabolites are the S-oxide (1%) and the desmethyl ranitidine (1%). The remainder of the administered dose is found in the stool. Studies in patients with hepatic dysfunction (compensated cirrhosis) indicate that there are minor, but clinically insignificant, alterations in ranitidine half-life, distribution, clearance, and bioavailability.
Excretion: The principal route of excretion is the urine, with approximately 30% of the orally administered dose collected in the urine as unchanged drug in 24 hours. Renal clearance is about 410 mL/min, indicating active tubular excretion. The elimination half-life is 2.5 to 3 hours.
Four patients with clinically significant renal function impairment (creatinine clearance 25 to 35 mL/min) administered 50 mg of ranitidine intravenously had an average plasma half-life of 4.8 hours, a ranitidine clearance of 29 mL/min, and a volume of distribution of
1.76L/kg. In general, these parameters appear to be altered in proportion to creatinine clearance (see DOSAGE AND ADMINISTRATION ). Geriatrics: The plasma half-life is prolonged and total clearance is reduced in the elderly population due to a decrease in renal function.
The elimination half-life is 3 to 4 hours. Peak levels average 526 ng/mL following a 150-mg twice-daily dose and occur in about 3 hours (see PRECAUTIONS: Geriatric Use and DOSAGE AND ADMINISTRATION: Dosage Adjustment for Patients with Impaired Renal Function ). Pediatrics: There are no significant differences in the pharmacokinetic parameter values for ranitidine in pediatric patients (from one month up to 16 yrs of age) and healthy adults when correction is made for body weight.
The average bioavailability of Ranitidine is given orally to pediatric patients is 48%, which is comparable to the bioavailability of Ranitidine in the adult population. All other pharmacokinetic parameter values (t 1/2 , Vd, and CL) are similar to those observed with intravenous Ranitidine use in pediatric patients. Estimates of C max and T max are displayed in Table 1.
Plasma clearance measured in 2 neonatal patients (less than 1 month of age) was considerably lower (3 mL/min/kg) than children or adults and is likely due to reduced renal function observed in this population (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION: Pediatric Use ). Pharmacodynamics: Serum concentrations necessary to inhibit 50% of stimulated gastric acid secretion are estimated to be 36 to 94 ng/mL. Following a single oral dose of 150 mg, serum concentrations of Ranitidine are in this range up to 12 hours.
However, blood levels bear no consistent relationship to dose or degree of acid inhibition. Antisecretory Activity: 1. Effects on Acid Secretion: Ranitidine Tablets inhibits both daytime and nocturnal basal gastric acid secretions as well as gastric acid secretion stimulated by food, betazole, and pentagas…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ranitidine Tablets USP, 150 mg (Ranitidine HCl equivalent to 150 mg of ranitidine) are orange, round shaped tablets debossed with ‘V’ on one side and ‘37’ on the other side. They are available in following count Bottles of 30 tablets (NDC 64980-636-03) Ranitidine Tablets USP, 300 mg (Ranitidine HCl equivalent to 300 mg of ranitidine) are yellow, oval shaped tablets debossed with ‘V’ on one side and ‘03’ on the other side. They are available in following count Bottles of 30 tablets (NDC 64980-637-03) Contains color additives including FD&C Yellow No.5 (tartrazine) Storage: Store at 15ºC to 30ºC (59ºF to 86ºF) [see USP controlled room temperature] in a dry place.
Dispense in the original container. Note to the Pharmacist: Inform the patient after first opening, store the tablets in the original bottle for up to 3 months (90 days). If the tablets are not used within 3 months (90 days), discard unused tablets.
The discard after date should be noted on the bottle. Replace cap securely after each opening. Keep the bottle tightly closed.
Do not remove desiccant from bottle. Protect from light. *MULTISTIX is a registered trademark of Bayer Healthcare LLC. Distributed by: Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816 Manufactured by: VKT Pharma Private Limited Srikakulam District, India-532-409 Issued: 12/2025 800425 ranitidine-companylogo
📋 Description ▾
DESCRIPTION Ranitidine Tablets USP are available for oral administration containing 150 mg or 300 mg of ranitidine. The active ingredient in Ranitidine Tablets USP, 150 mg and 300 mg is Ranitidine hydrochloride (HCl), USP, a histamine H 2 -receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl] methyl]thio]ethyl]-N´-methyl-2-nitro-1,1-ethenediamine, HCl.
It has the following structure: The emperical formula is C 13 H 22 N 4 O 3 S•HCl, representing a molecular weight of 350.87. Ranitidine HCl is white to pale yellow, crystalline, practically odorless powder, sensitive to light and moisture. Melts at about 140°C with decomposition.
Ranitidine is available as 150 mg and 300 mg tablets for oral administration. Each Ranitidine Tablet USP, 150 mg contains 150 mg ranitidine (equivalent to 168 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry ® 200 Orange 203A530006 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 6 and iron oxide yellow), purified water. Each Ranitidine Tablet USP, 300 mg contains 300 mg ranitidine (equivalent to 336 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry ® 200 Yellow 203A520014 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 5 and FD&C Blue 1), purified water.
Contains color additives including FD&C Yellow No.5 (tartrazine) Meets FDA approved specifications for nitrosamine impurities. ranitidine-hcl-struc