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Ranitidine 300 mg Tablet, 30-count — NDC 64980-0637-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ranitidine 300 mg Tablet, 30-count — NDC 64980-637-03 (Billing 64980-0637-03)

by Rising Pharma Holdings, Inc. · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Ranitidine 300 mg Tablet from Rising Pharma Holdings, Inc., marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.

NDC 64980-0637-03
🏷️ FDA NDC (as labeled) 64980-637-03 billing pads the product segment with a zero
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

NDC database record

One package, one record: these facts belong to NDC 64980-637-03 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
64980 labeler · 637 product · 03 package
Package marketed since
Dec 6, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
30 EA per package
Barcode (UPC)
0364980637039
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64980-637-03
Product NDC 64980-637
11-digit billing NDC 64980063703
NCPDP billing unit EA — each (per item)
RxCUI 198191, 198193
UNII BK76465IHM
UPC 0364980637039
Application # ANDA211289
SPL Set ID 0fba6615-37c2-4ba6-b6e5-09599369a5bc
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 2025-12-06
Route ORAL
Dosage form TABLET
Substance RANITIDINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 49200020100310
GCN Seq No 011674
GCN 10201
HICL code 004520
Ingredient (HICL) Ranitidine Hcl
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 56:28.12.00
AHFS class Histamine H2-Antagonists
FDB label name RANITIDINE 300 MG TABLET
FDB brand name Ranitidine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 011674
  • GCN: 10201
  • GPI-14 (Medi-Span): 49200020100310
  • HICL (First Databank): 004520
  • AHFS class code: 56:28.12.00
  • RxCUI (RxNorm): 198191
Why two NDCs? The FDA registers this code as 64980-637-03 — 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 → 64980-0637-03. 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 RANITIDINE 300 MG TABLET Ingredient Ranitidine Hcl
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • Ranitidine is used to reduce the amount of acid your stomach makes. Prescription versions treat ulcers in the stomach or small intestine, acid reflux disease (GERD), and acid damag...
  • No, food doesn't significantly affect how ranitidine works, so you can take it with or without a meal. For prescription forms, your doctor will tell you how often to take it — usua...
  • How should I take ranitidine — does it matter if I eat first?
  • Most people do fine on ranitidine. The most common complaints are headache, constipation, diarrhea, nausea, or an upset stomach. Dizziness or trouble sleeping can also happen. Thes...
📖 Read our full Ranitidine guide →
6
Nutrient depletion considerations

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

🧪 Full Ranitidine 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 $7.93 $238.01 / 30 tablets
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
64980-0637-03 You're viewing this Main listing 30 TABLET in 1 BOTTLE 2025-12-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ranitidine 300 mgthis 64980-0637-03 Rising 30 tablets — AB FDA listed —
Ranitidine 300 mg 53746-0254-01 Amneal 100 tablets — — FDA listed —
Ranitidine 300 mg 71993-0315-30 Atland 30 tablets — 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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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 orange / yellow
ShapeOval
ImprintV;03
Size16 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 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.
  • 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 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 I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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?
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

LabelerRising Pharma Holdings, Inc.
Application holderVKT PHARMA PRIVATE LTD
FDA applicationANDA211289 (ANDA)
Labeler code64980
First marketedDec 2025
Product typeHuman Prescription Drug
Portfolio525 products on file

More NDCs from Rising Pharma Holdings, Inc. labeler code 64980

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

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 ~3 min read ▾

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 22 words ▾

CONTRAINDICATIONS Ranitidine Tablets are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS ).

🤒 Adverse Reactions ~2 min read ▾

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 116 words ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 217 words ▾

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 ~1 min read ▾

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

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: Symptomatic response to therapy with Ranitidine Tablets does not preclude the presence of gastric malignancy. Since Ranitidine Tablets are excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function (see DOSAGE AND ADMINISTRATION ). Caution should be observed in patients with hepatic dysfunction since Ranitidine Tablets are metabolized in the liver.

Rare reports suggest that Ranitidine Tablets may precipitate acute porphyric attacks in patients with acute porphyria. Ranitidine Tablets should therefore be avoided in patients with a history of acute porphyria. This product contains FD&C Yellow No.

5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Laboratory Tests: False-positive tests for urine protein with MULTISTIX ® may occur during therapy with Ranitidine Tablets, and therefore testing with sulfosalicylic acid is recommended.

Drug Interactions: Ranitidine has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P 450 enzymes. Procainamide: Ranitidine, a substrate of the renal organic cation transport system, may affect the clearance of other drugs eliminated by this route. High doses of ranitidine (e.g., such as those used in the treatment of Zollinger-Ellison syndrome) have been shown to reduce the renal excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs.

Although this interaction is unlikely to be clinically relevant at usual ranitidine doses, it may prudent to monitor for procainamide toxicity when administered with oral ranitidine at a dose exceeding 300 mg per day. Warfarin: There have been reports of altered prothrombin time among patients on concomitant warfarin and ranitidine therapy. Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.

Ranitidine may alter the absorption of drugs in which gastric pH is an important determinant of bio-availability. This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in absorption (e.g., ketoconazole, Atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is recommended.

Atazanavir: Atazanavir absorption may be impaired based on known interactions with other agents that increase gastric pH. Use with caution. See atazanavir label for specific recommendations.

Delavirdine: Delavirdine absorption may be impaired based on known interactions with other agents that increase gastric pH. Chronic use of H 2 -receptor antagonists with delavirdine is not recommended. Gefitinib: Gefitinib exposure was reduced by 44% with the co-administration of ranitidine and sodium bicarbonate (dosed to maintain gastric pH above 5.0).

Use with caution. Glipizide: In diabetic patients, glipizide exposure was increased by 34% following a single 150 mg dose of oral ranitidine. Use appropriate clinical monitoring when initiating or discontinuing ranitidine.

Ketoconazole: Oral ketoconazole exposure was reduced by up to 95% when oral ranitidine was co-administered in a regimen to maintain a gastric pH of 6 or above. The degree of interaction with usual dose of ranitidine (150 mg twice daily) is unknown. Midazolam: Oral midazolam exposure in 5 healthy volunteers was increased by up to 65% when administered with oral ranitidine at a dose of 150 mg twice daily.

However, in another interaction trail in 8 volunteers receiving IV midazolam, a 300 mg oral dose of ranitidine increased midazolam exposure by about 9%. Monitor patients for excessive or prolo… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 29 words ▾

Rising ® PHARMACEUTICALS NDC 64980-636-03 Ranitidine Tablets USP, 150 mg 30 Tablets Rx only ranitidine-150mg-30ct

Rising® PHARMACEUTICALS NDC 64980-637-03 Ranitidine Tablets USP, 300 mg 30 Tablets Rx only ranitidine-300mg-30ct

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for RANITIDINE — the ingredient across all brands.

Top reported reactions

Breast Cancer29,413
Prostate Cancer26,446
Colorectal Cancer20,720
Bladder Cancer19,207
Renal Cancer19,035
Oesophageal Carcinoma11,066
Hepatic Cancer8,834

Age at onset

Neonate136
Infant97
Child265
Adolescent197
Adult7,430
Elderly3,424

Reporter sex

230,801 reports
Male · 48%
Female · 52%
Unknown · 0%

Serious outcomes

Death17,886
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 116,080 510
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Rising Pharma Holdings, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rising Pharma Holdings, Inc. 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.
← 64980-0636-03 · Rising 64980-0638-03 · Rising →
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.