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Famotidine 40 mg/5mL For Suspension, 50 mL — NDC 43598-572-11 (Billing 43598-0572-11)

by DR. REDDY'S LABORATORIES INC · 50 mL in 1 BOTTLE

This is a package of 50 mL of Famotidine 40 mg/5mL For Suspension from DR. REDDY'S LABORATORIES INC, marketed since Mar 2024 and currently FDA-listed. It is this product's only package size.

NDC 43598-0572-11
🏷️ FDA NDC (as labeled) 43598-572-11 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

⚠️
Other active recalls for Famotidine (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0809-2026
Class I · Nov 6, 2025 — Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. (Fresenius Kabi USA, LLC) · FDA recall D-0182-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43598-572-11
Product NDC 43598-572
11-digit billing NDC 43598057211
RxCUI 310274
UNII 5QZO15J2Z8
UPC 0343598572116
Application # ANDA217605
SPL Set ID 88ac92eb-5684-46c8-8cd2-3d4aefee26cf
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 2024-03-15
Route ORAL
Dosage form FOR SUSPENSION
Substance FAMOTIDINE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 310274
Why two NDCs? The FDA registers this code as 43598-572-11 — 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 → 43598-0572-11. 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

📗 Our plain-language guide HelloPharmacist
  • It reduces stomach acid. Over-the-counter versions relieve and prevent heartburn from acid indigestion and sour stomach. Prescription versions treat ulcers, GERD and erosive esopha...
  • With the over-the-counter tablets, swallow one with water and do not chew it. To prevent heartburn, take it shortly before a food or drink that triggers it. Do not take more than 2...
  • Headache, dizziness, constipation and diarrhea are the most common, and they are usually mild. Call your doctor if you have confusion, hallucinations, seizures, a rash with swellin...
  • Not always. Famotidine can lower absorption of some drugs that need stomach acid and can raise tizanidine levels. Tell me or your doctor everything you take before you start.
📖 Read our full Famotidine guide →
6
Nutrient depletion considerations

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

🧪 Full Famotidine 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 mLPer 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 $0.6788 $33.94 / 50 ml
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
43598-0572-11 You're viewing this Main listing 50 mL in 1 BOTTLE 2024-03-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Famotidine 40 mg/5mL 72205-0233-84 Novadoz 55 ml $0.073 AB Availability likely —
Famotidine 40 mg/5mL 27241-0249-49 Ajanta 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 31722-0063-31 Camber 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 42571-0433-45 Micro 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 59651-0701-50 Aurobindo 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 60219-2090-04 Amneal 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 67877-0775-89 Ascend 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 68180-0150-01 Lupin 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 68382-0444-05 Zydus 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 69238-2090-04 Amneal 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 70377-0113-11 Biocon 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 70954-0316-10 ANI 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 72603-0171-01 NorthStar 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 80005-0119-16 Carnegie 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 81033-0023-50 Kesin 50 ml $0.130 AB Availability likely —
Famotidine 40 mg/5mL 00832-6045-10 Upsher-Smith 100 ml $0.494 AB Availability likely —
Famotidine 40 mg/5mL 00527-5190-80 Lannett 55 ml — AB FDA listed —
Famotidine 40 mg/5mL 43386-0500-11 Lupin 50 ml — AB FDA listed —
Famotidine 40 mg/5mLthis 43598-0572-11 DR. 50 ml — AB FDA listed —
Famotidine 40 mg/5mL 51407-0452-50 Golden 50 ml — AB FDA listed —
famotidine 40 mg/5mL 68475-0400-01 Navinta 50 ml — AB FDA listed —
Famotidine 40 mg/5mL 72162-2599-02 Bryant 50 ml — AB FDA listed —
Famotidine 40 mg/5mL 64980-0737-50 RISING 50 ml — 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

🏛️
2024
On the market since
Mar 2024
📍
2026
Currently FDA-listed
2 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 INC
Application holderUNICHEM LABORATORIES LTD
FDA applicationANDA217605 (ANDA)
Labeler code43598
First marketedMar 2024
Product typeHuman Prescription Drug
Portfolio69 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 207 words ▾

1 INDICATIONS AND USAGE Famotidine for oral suspension is indicated in adults for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence. Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of: peptic ulcer disease.

GERD with or without esophagitis and ulcerations. Famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of: GERD. Famotidine is a histamine-2 (H 2 ) receptor antagonist indicated ( 1 ): In adults for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of DU recurrence.

In pediatric patients 1 year of age and older for the treatment of: peptic ulcer GERD with or without esophagitis and ulcerations In pediatric patients from birth to less than 1 year of age for the treatment of: GERD

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended adult dosage by indication ( 2.1 ): Active DU 40 mg once daily; or 20 mg twice daily Active GU 40 mg once daily Symptomatic Nonerosive GERD 20 mg twice daily Erosive Esophagitis due to GERD 20 mg twice daily; or 40 mg twice daily Pathological Hypersecretory Conditions 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours Risk Reduction of DU Recurrence 20 mg once daily Recommended pediatric dosage by indication ( 2.2 ): Peptic Ulcer Disease 1 year to less than 17 years Starting dosage 0.5 mg/kg once daily; or 0.25 mg/kg twice daily; may increase to 1 mg/kg once daily at bedtime or 0.5 mg/kg twice daily; Maximum of 40 mg per day GERD Birth to less than 3 months Starting dosage 0.5 mg/kg once daily; may increase to 1 mg/kg once daily 3 months to less than 1 year Starting dosage 0.5 mg/kg twice daily; may increase to 1 mg/kg twice daily; Maximum of 40 mg per day GERD with or without esophagitis and ulcerations 1 year to less than 17 years 0.5 mg/kg twice daily Maximum of 40 mg twice daily See full prescribing information for complete dosing information in adults and pediatrics, recommended treatment duration by indication, and dosage adjustment for adult patients with renal impairment.

( 2.1 , 2.2 , 2.3 ) Administration ( 2.3 ): Take once daily before bedtime or twice daily in the morning and before bedtime with or without food.

2.1Recommended Dosage in Adults The recommended dosage and duration of famotidine for oral suspension in adults with normal renal function is shown in Table 1 . Table 1: Recommended Dosage and Duration of Famotidine for Oral Suspension* in Adults with Normal Renal Function Indication Recommended Dosage Recommended Duration * After preparation, the concentration of famotidine oral suspension is 8 mg/mL [See Dosage and Administration ( 2.3 )] † Both dosages demonstrated effectiveness in clinical trials [see Clinical Studies ( 14 )] . ‡ In clinical trials, the majority of patients healed within 4 weeks.

For patients who do not heal after 4 weeks, consider an additional 2 to 4 weeks of treatment [see Clinical Studies ( 14.1 )]. § Longer treatment durations have not been studied in clinical trials [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . Active DU 40 mg once daily; or 20 mg twice daily † Up to 8 weeks ‡§ Active GU 40 mg once daily Up to 8 weeks § Symptomatic nonerosive GERD 20 mg twice daily Up to 6 weeks § Erosive esophagitis due to GERD, diagnosed by endoscopy 20 mg twice daily; or 40 mg twice daily † Up to 12 weeks Pathological hypersecretory conditions Starting dosage: 20 mg every 6 hours; adjust dosage to individual patient needs Maximum dosage 160 mg every 6 hours As clinically indicated Reduction of the risk of DU recurrence 20 mg once daily 1 year ‡§ or as clinically indicated

2.2Recommended Dosage in Pediatric Patients The recommended dosage and duration of famotidine for oral suspension in pediatric patients with normal renal function is shown in Table 2 . Table 2: Recommended Dosage and Duration of Famotidine for Oral Suspension * in Pediatric Patients with Normal Renal Function * After preparation, the concentration of famotidine oral suspension is 8 mg/mL [See Dosage and Administration ( 2.3 )] † Treatment duration based on adult recommendations (see Table 1 ). Individualize the dose and duration based upon clinical response an/or pH determinations (gastric or esophageal) and endoscopy. ‡ Use conservative measures (e.g., thickened feedings) concurrently [see Use in Specific Populations ( 8.4 )] . § After 4 weeks of treatment re- evaluate the patient.

Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks. Indication Pediatric Age Range Recommended Dosage * Duration Peptic Ulcer Disease 1 year to less than 17 years Starting dosage 0.5 mg/kg once daily; or 0.25 mg/kg twice daily. May increase to 1 mg/kg once daily at bedtime or 0.5 mg/kg twice daily Maximum of 40 mg per day 8 weeks † GERD Birth… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 48 words ▾

3 DOSAGE FORMS AND STRENGTHS Famotidine for oral suspension USP is a white to off-white granular powder forming an white to off-white suspension on constitution, containing 40 mg of famotidine per 5 mL. The suspension is a cherry-mint flavored. For oral suspension: 40 mg/5 mL ( 3 )

⛔ Contraindications 45 words ▾

4 CONTRAINDICATIONS Famotidine for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H2) receptor antagonists. History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H 2 receptor antagonists. ( 4 )

⚠️ Warnings and Cautions 180 words ▾

5 WARNINGS AND PRECAUTIONS Central Nervous System (CNS) Adverse Reactions: Elderly patients and patients with renal impairment at increased risk; reduce the dosage. ( 2.2 , 5.1 , 8.5 , 8.6 ) GI Malignancy: Absence of GI symptoms does not preclude the presence of gastric malignancy; evaluate prior to initiating therapy. ( 5.2 )

5.1Central Nervous System Adverse Reactions Central nervous system (CNS) adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy, have been reported in elderly patients and patients with moderate and severe renal impairment treated with famotidine. Since famotidine blood levels are higher in patients with renal impairment than in patients with normal renal function, dosage adjustments are recommended in patients with renal impairment [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )].

5.2Concurrent Gastric Malignancy In adults, symptomatic response to therapy with famotidine for oral suspension does not preclude the presence of gastric malignancy. Consider evaluation for gastric malignancy in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with famotidine for oral suspension.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cerovene, Inc. at 1-833-304-9569 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of famotidine for oral suspension has been established based on adequate and well-controlled studies of another oral famotidine product [see Clinical Studies ( 14 )]. The following is a summary of the adverse reactions reported in those studies.

Oral famotidine was studied in 7 US and international placebo- and active-controlled trials in approximately 2,500 patients [see Clinical Studies ( 14 )] . A total of 1,442 patients were treated with famotidine, including 302 treated with 40 mg twice daily, 456 treated with 20 mg twice daily, 461 treated with 40 mg once daily, and 396 treated with 20 mg once daily. The population was 17 to 91 years old, fairly well distributed between sex and race; however, the predominant race was Caucasian.

The following adverse reactions occurred in greater than or equal to 1% of famotidine-treated patients: headache, dizziness and constipation. The following other adverse reactions were reported in less than 1% of patients in clinical trials: Body as a Whole: fever, asthenia, fatigue Cardiovascular: palpitations Gastrointestinal: elevated liver enzymes, vomiting, nausea, abdominal discomfort, anorexia, dry mouth Hematologic: thrombocytopenia Hypersensitivity: orbital edema, rash, conjunctival injection, bronchospasm Musculoskeletal: musculoskeletal pain, arthralgia Nervous System/Psychiatric: seizure, hallucinations, depression, anxiety, decreased libido, insomnia, somnolence Skin: pruritus, dry skin, flushing Special Senses: tinnitus, taste disorder Other: impotence Pediatric Patients Less Than One Year of Age In a clinical study in 35 pediatric patients less than 1 year of age with GERD symptoms, two patients discontinued due to adverse reactions.

Agitation observed in 5 patients resolved when famotidine was discontinued [see Use in Specific Populations ( 8.4 )] .

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of famotidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: arrhythmia, AV block, prolonged QT interval Gastrointestinal: cholestatic jaundice, hepatitis Hematologic: agranulocytosis, pancytopenia, leukopenia Hypersensitivity: anaphylaxis, angioedema, facial edema, urticaria Musculoskeletal: rhabdomyolysis, muscle cramps Nervous System/Psychiatric: confusion, agitation, paresthesia Respiratory: interstitial pneumonia Skin: toxic epidermal necrolysis/Stevens-Johnson syndrome

🔄 Drug Interactions 197 words ▾

7 DRUG INTERACTIONS Drugs Dependent on Gastric pHfor Absorption : Systemic exposure of the concomitant drug may be significantly reduced leading to loss of efficacy. See full prescribing information for a list of interacting drugs. ( 7.1 ) Tizanidine (CYP1A2) Substrate: Potential for substantial increases in blood concentrations of tizanidine resulting in hypotension, bradycardia or excessive drowsiness; avoid concomitant use, if possible. ( 7.2 )

7.1Drugs Dependent on Gastric pH for Absorption Famotidine can reduce the absorption of other drugs, due to its effect on reducing intragastric acidity, leading to loss of efficacy of the concomitant drug. Concomitant administration of famotidine for oral suspension with dasatinib, delavirdine mesylate, cefditoren, and fosamprenavir is not recommended. See the prescribing information for other drugs dependent on gastric pH for absorption for administration instructions, including atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, and rilpivirine.

7.2Tizanidine (CYP1A2 Substrate) Although not studied clinically, famotidine is considered a weak CYP1A2 inhibitor and may lead to substantial increases in blood concentrations of tizanidine, a CYP1A2 substrate. Avoid concomitant use with famotidine for oral suspension. If concomitant use is necessary, monitor for hypotension, bradycardia or excessive drowsiness. Refer to the full prescribing information for tizanidine.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Geriatric Use: Use the lowest effective dose for an elderly patient and monitor renal function. ( 2.2 , 5.1 , 8.5 ) Renal Impairment: Risk of CNS adverse reactions and QT prolongation in patients with moderate and severe renal impairment; reduce the dosage in adults. ( 2.2 , 8.6 )

8.1Pregnancy Risk Summary Available data with H2-receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see Data ) . The estimated background risk for major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Reproductive studies have been performed in rats and rabbits at oral doses of up to 2,000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine.

While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

8.2Lactation Risk Summary There are limited data available on the presence of famotidine in human breast milk. There were no effects on the breastfed infant. There are no data on famotidine effects on milk production.

Famotidine is present in the milk of lactating rats (see Data ) . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for famotidine and any potential adverse effects on the breastfed child from famotidine for oral suspension or from the underlying maternal condition. Data Animal Data Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of famotidine at least 600 times the usual human dose.

8.4Pediatric Use Peptic Ulcer Disease and GERD With or Without Esophagitis and Ulcerations Pediatric Patients One Year to Less than 17 Years of Age The safety and effectiveness of famotidine for oral suspension have been established in pediatric patients 1 year to less than 17 years of age for the treatment of peptic ulcer disease and GERD with or without esophagitis and ulcerations. Use of famotidine in this age group is supported by evidence from adequate and well-controlled studies of famotidine in adults with additional pharmacokinetic and pharmacodynamic data in pediatric patients 1 year to less than 17 years of age [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.2 , 12.3 )] .

The safety and effectiveness of famotidine for oral suspension for the treatment of peptic ulcer disease in pediatric patients less than one year of age have not been established. GERD Pediatric Patients Less Than One Year of Age The safety and effectiveness of famotidine for oral suspension have been established in pediatric patients from birth to less than 1 year of age for the treatment of GERD. The use of famotidine this is age group is supported by evidence from adequate and well-controlled studies of famotidine in adult… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Available data with H2-receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see Data ) . The estimated background risk for major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Reproductive studies have been performed in rats and rabbits at oral doses of up to 2,000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine.

While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Peptic Ulcer Disease and GERD With or Without Esophagitis and Ulcerations Pediatric Patients One Year to Less than 17 Years of Age The safety and effectiveness of famotidine for oral suspension have been established in pediatric patients 1 year to less than 17 years of age for the treatment of peptic ulcer disease and GERD with or without esophagitis and ulcerations. Use of famotidine in this age group is supported by evidence from adequate and well-controlled studies of famotidine in adults with additional pharmacokinetic and pharmacodynamic data in pediatric patients 1 year to less than 17 years of age [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.2 , 12.3 )] .

The safety and effectiveness of famotidine for oral suspension for the treatment of peptic ulcer disease in pediatric patients less than one year of age have not been established. GERD Pediatric Patients Less Than One Year of Age The safety and effectiveness of famotidine for oral suspension have been established in pediatric patients from birth to less than 1 year of age for the treatment of GERD. The use of famotidine this is age group is supported by evidence from adequate and well-controlled studies of famotidine in adults and with supportive data in pediatric patients from birth to less than 1 year of age [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.2 , 12.3 ), Clinical Studies ( 14.7 )] .

Other Conditions The safety and effectiveness for the treatment of pathological hypersecretory conditions and reduction of risk of duodenal ulcer recurrence have not been established in pediatric patients. A safe and effective dosage has not been established in pediatric patients with renal impairment.

🧓 Geriatric Use 130 words ▾

8.5Geriatric Use Of the 1,442 famotidine-treated patients in clinical studies, approximately 10% were 65 and older. In these studies, no overall differences in safety or effectiveness were observed between elderly and younger patients. In postmarketing experience, CNS adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine [see Warnings and Precautions ( 5.1 )] .

Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine for oral suspension may be greater in elderly patients, particularly those with impaired renal function [see Use in Specific Populations ( 8.6 )] . In general, use the lowest effective dose of famotidine for oral suspension for an elderly patient and monitor renal function [see Dosage and Administration ( 2.2 )].

🆘 Overdosage 88 words ▾

10 OVERDOSAGE The types of adverse reactions in overdosage of famotidine are similar to the adverse reactions encountered with use of recommended dosages [see Adverse Reactions ( 6.1 )] . In the event of overdosage, treatment should be symptomatic and supportive. Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed.

Due to low binding to plasma proteins, famotidine is eliminated by hemodialysis. There is limited experience on the usefulness of hemodialysis as a treatment for famotidine overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Famotidine is a competitive inhibitor of histamine-2 (H2) receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output.

12.2Pharmacodynamics Adults Famotidine inhibited both basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After oral administration of famotidine, the onset of the antisecretory effect occurred within one hour; the maximum effect was dose-dependent, occurring within one to three hours. Duration of inhibition of secretion by doses of 20 mg and 40 mg was 10 to 12 hours.

Single evening oral doses of 20 mg and 40 mg inhibited basal and nocturnal acid secretion in all subjects; mean nocturnal gastric acid secretion was inhibited by 86% and 94%, respectively, for a period of at least 10 hours. The same doses given in the morning suppressed food-stimulated acid secretion in all subjects. The mean suppression was 76% and 84%, respectively, 3 to 5 hours after administration, and 25% and 30%, respectively, 8 to 10 hours after administration.

In some subjects who received the 20 mg dose, however, the antisecretory effect was dissipated within 6 to 8 hours. There was no cumulative effect with repeated doses. The nocturnal intragastric pH was raised by evening doses of 20 mg and 40 mg of famotidine to mean values of 5 and 6.4, respectively.

When famotidine was given after breakfast, the basal daytime interdigestive pH at 3 and 8 hours after 20 mg or 40 mg of famotidine was raised to about 5. Famotidine had little or no effect on fasting or postprandial serum gastrin levels. Gastric emptying and exocrine pancreatic function were not affected by famotidine.

In clinical pharmacology studies, systemic effects of famotidine in the CNS, cardiovascular, respiratory or endocrine systems were not noted. Also, no anti-androgenic effects were noted. Serum hormone levels, including prolactin, cortisol, thyroxine (T4), and testosterone, were not altered after treatment with famotidine.

Pediatric Patients Pharmacodynamics of famotidine, assessed by gastric pH, were evaluated in 5 pediatric patients 2 years to 13 years of age using the sigmoid E max model. These data suggest that the relationship between serum concentration of famotidine and gastric acid suppression is similar to that observed in adults (see Table 4 ). Table 4: Serum Concentrations of Famotidine Associated with Gastric Acid Reduction in Famotidine-Treated Pediatric and Adult Patients* * Using the Sigmoid E max model, serum concentrations of famotidine associated with 50% maximum gastric acid reduction are presented as means ± SD.

EC 50 (ng/mL) * Pediatric Patients 26 ± 13 Adults Healthy adult subjects 26.5 ±

10.3Adult patients with upper GI bleeding 18.7 ±

10.8In a study examining the effect of famotidine on gastric pH and duration of acid suppression in pediatric patients, four pediatric patients ages 11 to 15 years of age using the oral formulation at a dose of 0.5 mg/kg, maintained a gastric pH above 5 for 13.5 ± 1.8 hours.

12.3Pharmacokinetics Absorption Famotidine is incompletely absorbed. The bioavailability of oral doses is 40 to 45%. Bioavailability may be slightly increased by food, or slightly decreased by antacids; however, these effects are of no clinical consequence.

Peak famotidine plasma levels occur in 1 to 3 hours. Plasma levels after multiple dosages are similar to those after single doses. Distribution Fifteen to 20% of famotidine in plasma is protein bound.

Elimination Metabolism Famotidine undergoes minimal first-pass metabolism. Twenty-five to 30% of an oral dose was recovered in the urine as unchanged compound. The only metabolite identified in humans is the S-oxide.

Excretion Famotidine has an elimination half-life of 2.5 to 3.5 hours. Fam… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 49 words ▾

12.1Mechanism of Action Famotidine is a competitive inhibitor of histamine-2 (H2) receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output.

📦 How Supplied / Storage and Handling 108 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Famotidine for oral suspension is supplied as follows: NDC Strength Quantity Description 43598-572-11 40 mg Bottle Famotidine for oral suspension USP is a white to off-white granular powder forming an white to off-white suspension on constitution, containing 40 mg of famotidine per 5 mL. The suspension is a cherry-mint flavored. Prior to dispensing, constitute famotidine for oral suspension [see Dosage and Administration ( 2.3 )] Storage: Store famotidine for oral suspension dry powder and constituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect from freezing. Discard unused constituted suspension after 30 days.

📋 Description 127 words ▾

11 DESCRIPTION The active ingredient in famotidine for oral suspension is a histamine-2 (H2) receptor antagonist. Famotidine is N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4- thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.43.

Its structural formula is: Each 5 mL of famotidine for oral suspension when prepared as directed contains 40 mg of famotidine and the following inactive ingredients: anhydrous citric acid, corn starch, flavors (cherry and mint), maltodextrin, sucrose, and xanthan gum. Added as preservatives are methylparaben sodium, propylparaben sodium and sodium benzoate. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.

Structural Formula

💬 Information for Patients 170 words ▾

17 PATIENT COUNSELING INFORMATION Central Nervous System (CNS) Adverse Reactions Advise elderly patients and those with moderate and severe renal impairment of the risk of CNS adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy [see Warnings and Precautions ( 5.1 )] . Report symptoms immediately to a healthcare provider. QT Prolongation Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation [see Use in Specific Populations ( 8.6 )] .

Report new cardiac symptoms, such as palpitations, fainting and dizziness or lightheadedness immediately to a healthcare provider. Administration Advise patients to take and caregivers to administer: Famotidine for oral suspension once daily before bedtime or twice daily in the morning and before bedtime, as recommended. Advise patients and caregivers: Famotidine for oral suspension may be taken with or without food.

Famotidine for oral suspension may be given with antacids. Rx Only Manufactured by: Cerovene, Inc. Valley Cottage, NY 10989 Manufactured For: Dr.

Reddy's Laboratories Inc. Princeton, NJ 08540 USA Cerovene Issued: 01/2024

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Famotidine is incompletely absorbed. The bioavailability of oral doses is 40 to 45%. Bioavailability may be slightly increased by food, or slightly decreased by antacids; however, these effects are of no clinical consequence.

Peak famotidine plasma levels occur in 1 to 3 hours. Plasma levels after multiple dosages are similar to those after single doses. Distribution Fifteen to 20% of famotidine in plasma is protein bound.

Elimination Metabolism Famotidine undergoes minimal first-pass metabolism. Twenty-five to 30% of an oral dose was recovered in the urine as unchanged compound. The only metabolite identified in humans is the S-oxide.

Excretion Famotidine has an elimination half-life of 2.5 to 3.5 hours. Famotidine is eliminated by renal (65 to 70%) and metabolic (30 to 35%) routes. Renal clearance is 250 to 450 mL/minute, indicating some tubular excretion.

Specific Populations Pediatric Patients Infants from birth to 12 Months After a single oral dose administration of 0.5 mg/kg orally in patients from birth to 12 months, the bioavailability is approximately 42%. The AUC increased 1.4-fold after single oral dose of 1 mg/kg compared to 0.5 mg/kg and 2.7-fold after multiple oral doses of 1 mg/kg compared to 0.5 mg/kg. Plasma clearance is reduced and elimination half-life is prolonged in pediatric patients from birth to 3 months of age compared to older pediatric patients.

Following intravenous administration of 0.5 mg/kg, CLTotal was 0.13 ±0.06 L/hr/kg, 0.21 ±

0.06L/hr/kg, and 0.49 ±

0.17L/hr/kg in pediatric patients <1 month of age, <3 months of age, and >3 to 12 months of age, respectively. Elimination half-life was 10.5 hours, 8.1 hours, and 4.5 hours in pediatric patients <1 month of age, <3 months of age, and >3 to 12 months of age, respectively. Patients 11 Years to 15 Years The mean bioavailability in 8 pediatric patients was 50% compared to adult values of 42% to 49%.

Pharmacokinetic parameters in pediatrics 11 years to 15 years is compared to infants from birth to 12 months in Table 5 . Table 5: Mean Pharmacokinetic Parameters Following a Single Oral Dose of 0.5 mg/kg in Infants and Pediatric Patients * arithmetic mean ± S.D. † median ‡ observed minimum and maximum values § reported minimum and maximum values Infants from Birth to 12 Months (N=5) Pediatric Patients 11 Years to 15 Years (N=8) AUC 0-∞ (ng*hr/mL) * 645 ± 249 580 ± 60 C max (ng/mL) 79.2

97.3T max (hr) † 2.0 (1.0, 4.1) ‡ 2.3 (2.1, 2.9) § T 1/2 (hr) 5.82

2.13Patients with Renal Impairment In adult patients with severe renal impairment (creatinine clearance less than 30 mL/minute), the systemic exposure (AUC) of famotidine increased at least 5-fold. In adult patients with moderate renal impairment (creatinine clearance between 30 to 60 mL/minute), the AUC of famotidine increased at least 2-fold [see Dosage and Administration ( 2.3 ), Use in Specific Populations ( 8.6 )] . Drug Interaction Studies Human Organic Anion Transporter (OAT) 1 and 3: In vitro studies indicate that famotidine is a substrate for OAT1 and OAT3.

Following coadministration of probenecid (1,500 mg), an inhibitor of OAT1 and OAT3, with a single oral 20 mg dose of famotidine in 8 healthy subjects, the serum AUC 0-10h of famotidine increased from 424 to 768 ng□hr/mL and the maximum serum concentration (C max ) increased from 73 to 113 ng/mL. Renal clearance, urinary excretion rate and amount of famotidine excreted unchanged in urine were decreased. The clinical relevance of this interaction is unknown.

Multidrug and Toxin Extrusion Protein 1 (MATE-1): An in vitro study showed that famotidine is an inhibitor of MATE-1. However, no clinically significant interaction with metformin, a substrate for MATE-1, was observed. CYP1A2: Famotidine is a weak CYP1A2 inhibitor.

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Adults Famotidine inhibited both basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After oral administration of famotidine, the onset of the antisecretory effect occurred within one hour; the maximum effect was dose-dependent, occurring within one to three hours. Duration of inhibition of secretion by doses of 20 mg and 40 mg was 10 to 12 hours.

Single evening oral doses of 20 mg and 40 mg inhibited basal and nocturnal acid secretion in all subjects; mean nocturnal gastric acid secretion was inhibited by 86% and 94%, respectively, for a period of at least 10 hours. The same doses given in the morning suppressed food-stimulated acid secretion in all subjects. The mean suppression was 76% and 84%, respectively, 3 to 5 hours after administration, and 25% and 30%, respectively, 8 to 10 hours after administration.

In some subjects who received the 20 mg dose, however, the antisecretory effect was dissipated within 6 to 8 hours. There was no cumulative effect with repeated doses. The nocturnal intragastric pH was raised by evening doses of 20 mg and 40 mg of famotidine to mean values of 5 and 6.4, respectively.

When famotidine was given after breakfast, the basal daytime interdigestive pH at 3 and 8 hours after 20 mg or 40 mg of famotidine was raised to about 5. Famotidine had little or no effect on fasting or postprandial serum gastrin levels. Gastric emptying and exocrine pancreatic function were not affected by famotidine.

In clinical pharmacology studies, systemic effects of famotidine in the CNS, cardiovascular, respiratory or endocrine systems were not noted. Also, no anti-androgenic effects were noted. Serum hormone levels, including prolactin, cortisol, thyroxine (T4), and testosterone, were not altered after treatment with famotidine.

Pediatric Patients Pharmacodynamics of famotidine, assessed by gastric pH, were evaluated in 5 pediatric patients 2 years to 13 years of age using the sigmoid E max model. These data suggest that the relationship between serum concentration of famotidine and gastric acid suppression is similar to that observed in adults (see Table 4 ). Table 4: Serum Concentrations of Famotidine Associated with Gastric Acid Reduction in Famotidine-Treated Pediatric and Adult Patients* * Using the Sigmoid E max model, serum concentrations of famotidine associated with 50% maximum gastric acid reduction are presented as means ± SD.

EC 50 (ng/mL) * Pediatric Patients 26 ± 13 Adults Healthy adult subjects 26.5 ±

10.3Adult patients with upper GI bleeding 18.7 ±

10.8In a study examining the effect of famotidine on gastric pH and duration of acid suppression in pediatric patients, four pediatric patients ages 11 to 15 years of age using the oral formulation at a dose of 0.5 mg/kg, maintained a gastric pH above 5 for 13.5 ± 1.8 hours.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The safety and effectiveness of famotidine for oral suspension have been established based on adequate and well-controlled studies of another oral famotidine product. The following is a summary of the efficacy results reported in those studies.

14.1Active Duodenal Ulcer In a U.S. multicenter, double-blind trial in adult outpatients with endoscopically confirmed duodenal ulcer (DU), orally administered famotidine was compared to placebo. As shown in Table 6 , 70% of patients treated with famotidine 40 mg at bedtime were healed by Week 4. Most patients' DU healed within 4 weeks.

Patients not healed by Week 4 were continued in the trial. By Week 8, 83% of patients treated with famotidine had healed DU, compared to 45% of patients treated with placebo. The incidence of DU healing with famotidine was greater than with placebo at each time point based on proportion of endoscopically confirmed healed DUs.

Trials have not assessed the safety of famotidine in uncomplicated active DU for periods of more than 8 weeks. Table 6: Patients with Endoscopically Confirmed Healed Duodenal Ulcers * p<0.001 vs. placebo Famotidine 40 mg at bedtime (N=89) Famotidine 20 mg twice daily (N=84) Placebo at bedtime (N=97) Week 2 32% * 38% * 17% Week 4 70% * 67% * 31% In this study, time to relief of daytime and nocturnal pain was shorter for patients receiving famotidine than for patients receiving placebo; patients receiving famotidine also took less antacid than patients receiving placebo.

14.2Active Gastric Ulcer In both a U.S. and an international multicenter, double-blind trials in patients with endoscopically confirmed active gastric ulcer (GU), orally administered famotidine 40 mg at bedtime was compared to placebo. Antacids were permitted during the trials, but consumption was not significantly different between the famotidine and placebo groups. As shown in Table 7 , the incidence of GU healing confirmed by endoscopy (dropouts counted as unhealed) with famotidine was greater than placebo at Weeks 6 and 8 in the U.S. trial, and at Weeks 4, 6 and 8 in the international trial.

In these trials, most famotidine-treated patients healed within 6 weeks. Trials have not assessed the safety of famotidine in uncomplicated active GU for periods of more than 8 weeks. Table 7: Patients with Endoscopically Confirmed Healed Gastric Ulcers * p≤0.01 vs. placebo † p≤0.05 vs. placebo U.S.

Study (N=149) International Study (N=294) Famotidine 40 mg at bedtime Placebo Famotidine Placebo (N=74) at bedtime 40 mg at at bedtime (N=75) bedtime (N=145) (N=149) Week 4 45% 39% 47% * 31% Week 6 66% * 44% 65% * 46% Week 8 78% † 64% 80% * 54% Time to complete relief of daytime and nighttime pain was statistically significantly shorter for patients receiving famotidine than for patients receiving placebo; however, neither trial demonstrated a statistically significant difference in the proportion of patients whose pain was relieved by the end of the trial (Week 8).

14.3Symptomatic Gastroesophageal Reflux Disease (GERD) Orally administered famotidine was compared to placebo in a U.S. trial that enrolled patients with symptoms of GERD and without endoscopic evidence of esophageal erosion or ulceration. As shown in Table 8 , patients treated with famotidine 20 mg twice daily had greater improvement in symptomatic GERD than patients treated with 40 mg at bedtime or placebo. Table 8: Patients with Improvement of Symptomatic GERD (N=376) * p≤0.01 vs. placebo Famotidine 20 mg twice daily (N=154) Famotidine 40 mg at bedtime (N=149) Placebo at bedtime (N=73) Week 6 82% * 69% 62%

14.4Erosive Esophagitis due to GERD Healing of endoscopically verified erosion and symptomatic improvement were studied in a U.S. and an international double-blind trials. Healing was defined as complete resolution of all erosions visible with endoscopy. The U.S. trial comparing orally administered famotidine 40 mg twice daily to placebo and orally administered famotidine 20 mg twice daily s… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 174 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenic potential of famotidine was assessed in a 106-week oral carcinogenicity study in rats and a 92-week oral carcinogenicity study in mice. In the 106-week study in rats and the 92-week study in mice at oral doses of up to 2,000 mg/kg/day (approximately 243 and 122 times, respectively, based on body surface area, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis), there was no evidence of carcinogenic potential for famotidine.

Famotidine was negative in the microbial mutagen test (Ames test) using Salmonella typhimurium and Escherichia coli with or without rat liver enzyme activation at concentrations up to 10,000 mcg/plate. In in vivo studies in mice, with a micronucleus test and a chromosomal aberration test, no evidence of a mutagenic effect was observed. In studies with rats given oral doses of up to 2,000 mg/kg/day (approximately 243 times, based on body surface area, the recommended human dose of 80 mg per day) fertility and reproductive performance were not affected.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 171 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenic potential of famotidine was assessed in a 106-week oral carcinogenicity study in rats and a 92-week oral carcinogenicity study in mice. In the 106-week study in rats and the 92-week study in mice at oral doses of up to 2,000 mg/kg/day (approximately 243 and 122 times, respectively, based on body surface area, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis), there was no evidence of carcinogenic potential for famotidine.

Famotidine was negative in the microbial mutagen test (Ames test) using Salmonella typhimurium and Escherichia coli with or without rat liver enzyme activation at concentrations up to 10,000 mcg/plate. In in vivo studies in mice, with a micronucleus test and a chromosomal aberration test, no evidence of a mutagenic effect was observed. In studies with rats given oral doses of up to 2,000 mg/kg/day (approximately 243 times, based on body surface area, the recommended human dose of 80 mg per day) fertility and reproductive performance were not affected.

📄 Package Label / Principal Display Panel 61 words ▾

Principal Display Panel – 50 mL Bottle Label NDC 43598- 572 -11 Famotidine for Oral Suspension, USP 40 mg/5 mL 400 mg of famotidine Constituted to 50 mL, each 5 mL contains 40 mg of famotidine FOR ORAL USE ONLY SHAKE WELL BEFORE EACH USE 50 mL (when reconstituted) Rx Only Dr. Reddy's Principal Display Panel – 50 mL Bottle Label

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 Famotidine — the program that covers self-administered drugs. 29 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 Famotidine. 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
$40.22M
Claims incl. refills
3.8M
Beneficiaries
2.6M
Spend / beneficiary
$15.35
Spend / claim
$10.62
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

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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 — Not published for this NDC No photo available yet for this listing.
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Orange Book / therapeutic-equivalence data ✓ Available
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“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 INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DR. REDDY'S LABORATORIES 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.
← 43598-0566-01 · Dr.Reddy's 43598-0573-30 · Dr.Reddys →
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.