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FAMOTIDINE 40 mg/5mL Powder, For Suspension, 50 mL — NDC 42571-0433-45 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

FAMOTIDINE 40 mg/5mL Powder, For Suspension, 50 mL — NDC 42571-433-45 (Billing 42571-0433-45)

by Micro Labs Limited · 50 mL in 1 BOTTLE

This is a package of 50 mL of FAMOTIDINE 40 mg/5mL Powder, For Suspension from Micro Labs Limited, marketed since Dec 2023 and currently FDA-listed; retail pharmacies pay about $0.1305 per mL (NADAC). It is this product's only package size.

NDC 42571-0433-45
🏷️ FDA NDC (as labeled) 42571-433-45 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) 42571-433-45
Product NDC 42571-433
11-digit billing NDC 42571043345
NCPDP billing unit ML — per mL (volume)
RxCUI 310274
UNII 5QZO15J2Z8
UPC 0342571433451
Application # ANDA217842
SPL Set ID 1756ab7d-05c4-4726-8f72-4e8363440968
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 2023-12-01
Route ORAL
Dosage form POWDER, FOR SUSPENSION
Substance FAMOTIDINE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 49200030001920
GCN Seq No 011676
GCN 45960
HICL code 004521
Ingredient (HICL) Famotidine
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2D
Therapeutic class — specific (HIC3) Histamine H2-Receptor Inhibitors
AHFS code 04:92.00.00
AHFS class Other Antihistamines
FDB label name FAMOTIDINE 40 MG/5 ML SUSP
FDB brand name Famotidine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 011676
  • GCN: 45960
  • GPI-14 (Medi-Span): 49200030001920
  • HICL (First Databank): 004521
  • AHFS class code: 04:92.00.00
  • RxCUI (RxNorm): 310274
Why two NDCs? The FDA registers this code as 42571-433-45 — 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 → 42571-0433-45. 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 FAMOTIDINE 40 MG/5 ML SUSP Ingredient Famotidine
📖 What it is MedlinePlus · NLM

Famotidine injection is used in people who are hospitalized to treat certain conditions in which the stomach produces too much acid or to treat ulcers (sores in the lining of the stomach or intestine) that were not successfully treated with other medications. Famotidine injection is also used on a short-term basis in people who cannot take oral medication to treat ulcers, to prevent ulcers from returning after they have healed, to treat gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube betwe...

Read the full MedlinePlus article ↗
📗 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 $0.131 $6.53 / 50 ml
Medicaid paysCMS SDUD · 12 mo $0.3738 $18.69 / 50 ml
Medicare drug plans payPart D · Q2 2026 $0.6788 $33.94 / 50 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.214 $0.131
▼ Down 39% over the last 10 months.
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
42571-0433-45 You're viewing this Main listing 50 mL in 1 BOTTLE 2023-12-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Famotidine 40 mg/5mL 72205-0233-84 Novadoz 55 ml $0.073 AB Availability likely save 44%
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/5mLthis 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 +279%
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/5mL 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
FlavorStrawberry
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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII CR6K9C2NHK
    A synthetic preservative derived from methylparaben. It prevents bacterial and fungal growth in medicines, extending shelf life and maintaining product safety during storage.
  • UNII SMD1X3XO9M
    Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.
  • UNII 625NNB0G9N
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps keep the product safe and stable throughout its shelf life.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

7 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

LabelerMicro Labs Limited
Application holderMICRO LABS LTD
FDA applicationANDA217842 (ANDA)
Labeler code42571
First marketedDec 2023
Product typeHuman Prescription Drug
Portfolio190 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 209 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 DU 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 for oral suspension 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 ( 2.4 ): 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. After preparation, the concentration of famotidine for oral suspension is 8 mg/mL [see Dosage and Administration ( 2.3 )] . Table 1: Recommended Dosage and Duration of Famotidine for Oral Suspension in Adults with Normal Renal Function Indication Recommended Dosage Recommended Duration Active DU 40 mg once daily; or 20 mg twice daily a Up to 8 weeks b, c Active GU 40 mg once daily Up to 8 weeks c Symptomatic nonerosive GERD 20 mg twice daily Up to 6 weeks c Erosive esophagitis due to GERD, diagnosed by endoscopy 20 mg twice daily; or 40 mg twice daily a 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 b,c or as clinically indicated a Both dosages demonstrated effectiveness in clinical trials [see Clinical Studies ( 14 )] . b 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 )]. c Longer treatment durations have not been studied in clinical trials [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] .

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. After preparation, the concentration of famotidine for oral suspension is 8 mg/mL [see Dosage and Administration ( 2.3 )] . Table 2: Recommended Dosage and Duration of Famotidine for Oral Suspension in Pediatric Patients with Normal Renal Function 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 a GERD Birth to less than 3 months Starting dosage 0.5 mg/kg once daily.

May increase to 1 mg/kg once daily a Up to 8 weeks a,b,c 3 months to less than 1 year Starting dosage 0.5 mg/kg twice daily. May increase to 1 mg/kg twice daily b 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 6 to 12 weeks a a Treatment duration based on adult recommendations (see Ta… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 55 words ▾

3 DOSAGE FORMS AND STRENGTHS For Oral Suspension: 400 mg as a white to off-white powder. When constituted as directed, famotidine suspension is a white to off-white, homogeneous suspension with a strawberry-orange flavor, containing 40 mg of famotidine, USP per 5 mL. For oral suspension: 50 mL after reconstitution (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 H 2 -receptor antagonists. History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H 2 -receptor antagonists. ( 4 )

⚠️ Warnings and Cautions 184 words ▾

5 WARNINGS AND PRECAUTIONS • Central Nervous System (CNS) Adverse Reactions : Elderly patients and patients with renal impairment at increased risk; reduce the dosage. ( 2.1 , 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 Micro Labs USA Inc. at 1-855-839-8195 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 U.S. and international placebo- and active-controlled trials in approximately 2500 patients [see Clinical Studies ( 14 )] . A total of 1442 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 White.

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 1 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 191 words ▾

7 DRUG INTERACTIONS • Drugs Dependent on Gastric pH for Absorption : Systemic exposure of the concomitant drug may be significantly reduced leading to loss of efficacy. ( 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. ( 2.1 , 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. ( 2.3 , 8.6 )

8.1Pregnancy Risk Summary Available data with H 2 -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/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 2000 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/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 1 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 for oral suspension 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 ( 2.2 ), 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 1 year of age have not been established. GERD Pediatric Patients Less Than 1 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 for oral suspension in this age group is supported by evidence from adequate and well-controlled stu… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Available data with H 2 -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/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 2000 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/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 1 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 for oral suspension 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 ( 2.2 ), 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 1 year of age have not been established. GERD Pediatric Patients Less Than 1 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 for oral suspension in this 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 ( 2.2 ), 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 DU 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 1442 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 H 2 -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 1 hour; the maximum effect was dose-dependent, occurring within 1 to 3 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 5.0 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 a pH level of 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 (T 4 ), 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 a EC 50 (ng/mL) a Pediatric Patients 26 ± 13 Adults Healthy adult subjects 26.5 ±

10.3Adult patients with upper GI bleeding 18.7 ± 10.8 a Using the sigmoid E max model, serum concentrations of famotidine associated with 50% maximum gastric acid reduction are presented as mean ± SD. In 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. Famoti… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 49 words ▾

12.1Mechanism of Action Famotidine is a competitive inhibitor of H 2 -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 107 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Famotidine for oral suspension, USP is supplied as follows: NDC Strength Quantity Description NDC 42571-433-45 40 mg Bottle with child-resistant cap white to off-white powder. When constituted as directed, famotidine oral suspension is a white to off-white, homogeneous suspension with a strawberry-orange flavor, containing 40 mg of famotidine, USP per 5 mL. Prior to dispensing, constitute famotidine for oral suspension, USP [see Dosage and Administration ( 2.4 )] .

Storage Store famotidine for oral suspension, USP dry powder at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a USP tight, light-resistant container.

📋 Description 139 words ▾

11 DESCRIPTION The active ingredient in famotidine for oral suspension, USP is a H 2 -receptor antagonist. Famotidine is N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.45.

Its structural formula is: Famotidine, USP is a white to pale yellowish white crystalline powder that is freely soluble in glacial acetic acid and dimethylformamide, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate. Each 5 mL of famotidine for oral suspension when prepared as directed contains 40 mg of famotidine, USP and the following inactive ingredients: citric acid monohydrate, flavors (strawberry, orange), powdered cellulose, sucrose and xanthan gum.

Added as preservatives are sodium benzoate, sodium methylparaben and sodium propylparaben. famotidine-str.jpg

💬 Information for Patients 193 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 Interval 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 using an oral dosing syringe to correctly measure the prescribed amount of medication. Oral dosing syringes may be obtained from the pharmacy.

Shake the bottle of reconstituted famotidione for oral suspension vigorously for 5 to 10 seconds prior to each use. Take once daily before bedtime or twice daily in the morning and before bedtime, as recommended, with or without food. May be given with antacids.

Manufactured by: Micro Labs Limited Goa-403722. INDIA. Manufactured for: Micro Labs USA, Inc.

Somerset, NJ 08873 Rev. 07/2025

🧬 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/min, 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, CL Total was 0.13 ±

0.06L/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 pediatric patients 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 Infants from Birth to 12 Months (N=5) Pediatric Patients 11 Years to 15 Years (N=8) AUC 0 to ∞ (ng*hr/mL) a 645 ± 249 580 ± 60 C max (ng/mL) 79.2

97.3T max (hr) b 2.0 (1.0, 4.1) c 2.3 (2.1, 2.9) d T 1/2 (hr) 5.82 2.13 a arithmetic mean ± S.D. b median c observed minimum and maximum values d reported minimum and maximum values Patients with Renal Impairment In adult patients with severe renal impairment (creatinine clearance less than 30 mL/min), 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/min), 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 co-administration of probenecid (1500 mg), an inhibitor of OAT1 and OAT3, with a single oral 20 mg dose of famotidine in 8 healthy subjects, the serum AUC 0 to 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 1 hour; the maximum effect was dose-dependent, occurring within 1 to 3 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 5.0 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 a pH level of 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 (T 4 ), 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 a EC 50 (ng/mL) a Pediatric Patients 26 ± 13 Adults Healthy adult subjects 26.5 ±

10.3Adult patients with upper GI bleeding 18.7 ± 10.8 a Using the sigmoid E max model, serum concentrations of famotidine associated with 50% maximum gastric acid reduction are presented as mean ± SD. In 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 (DU) 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 Famotidine 40 mg at bedtime (N=89) Famotidine 20 mg twice daily (N=84) Placebo at bedtime (N=97) Week 2 32% a 38% a 17% Week 4 70% a 67% a 31% a p<0.001 vs. placebo 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 (GU) In both a U.S. and an international multicenter, double-blind trials in patients with endoscopically confirmed active 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 U.S.

Study (N=149) International Study (N=294) Famotidine 40 mg at bedtime (N=74) Placebo at bedtime (N=75) Famotidine 40 mg at bedtime (N=149) Placebo at bedtime (N=145) Week 4 45% 39% 47% a 31% Week 6 66% a 44% 65% a 46% Week 8 78% b 64% 80% a 54% a p≤0.01 vs. placebo b p≤0.05 vs. placebo 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) Famotidine 20 mg twice daily (N=154) Famotidine 40 mg at bedtime (N=149) Placebo at bedtime (N=73) Week 6 82% a 69% 62% a p≤0.01 vs. placebo

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 trial. 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 showed a s… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 170 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 2000 mg/kg/day (approximately 243 and 122 times, respectively, based on body surface area, the recommended human dose of 80 mg/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 2000 mg/kg/day (approximately 243 times, based on body surface area, the recommended human dose of 80 mg/day) fertility and reproductive performance were not affected.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 167 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 2000 mg/kg/day (approximately 243 and 122 times, respectively, based on body surface area, the recommended human dose of 80 mg/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 2000 mg/kg/day (approximately 243 times, based on body surface area, the recommended human dose of 80 mg/day) fertility and reproductive performance were not affected.

📄 Package Label / Principal Display Panel 36 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 42571-433-45 Famotidine for Oral Suspension, USP 40 mg/5 mL 400 mg of famotidine When reconstitued as directed, each teaspoonful (5 mL) contains famotidine USP 40 mg. 50 mL (After reconstituted) famotidine-50ml.jpg

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
38.3K
Units reimbursed last 4 qtrs
2.6M
Gross reimbursed last 4 qtrs
$982.8K
Avg / prescription
$25.64
Avg / unit
$0.3738
Latest quarter Q1 2026
11.3KRx
Medicaid pays / mL
$0.3738
gross reimbursed
vs
NADAC / mL
$0.1305
acquisition cost
=
Spread
+$0.2433
+186% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
52% FFS 48% MCO
Fee-for-service · 19,885 Rx Managed care · 18,446 Rx
State Medicaid map
Alaska: no data reported AK Maine: 46,750 units · 3,351 per 100k residents ME Washington: 13,500 units · 173 per 100k residents WA Idaho: 19,480 units · 992 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 33,775 units · 589 per 100k residents MN Wisconsin: 34,625 units · 586 per 100k residents WI Michigan: 26,550 units · 265 per 100k residents MI New York: 230,778 units · 1,179 per 100k residents NY Vermont: 32,400 units · 5,008 per 100k residents VT New Hampshire: no data reported NH Oregon: 6,250 units · 148 per 100k residents OR Nevada: 15,950 units · 499 per 100k residents NV Wyoming: 12,100 units · 2,072 per 100k residents WY South Dakota: 2,900 units · 316 per 100k residents SD Iowa: 12,415 units · 387 per 100k residents IA Illinois: 113,709 units · 906 per 100k residents IL Indiana: 3,400 units · 49.5 per 100k residents IN Ohio: 23,935 units · 203 per 100k residents OH Pennsylvania: 26,331 units · 203 per 100k residents PA New Jersey: 40,008 units · 431 per 100k residents NJ Massachusetts: 27,900 units · 399 per 100k residents MA California: 427,505 units · 1,097 per 100k residents CA Utah: 39,650 units · 1,160 per 100k residents UT Colorado: 150,150 units · 2,554 per 100k residents CO Nebraska: 38,436 units · 1,943 per 100k residents NE Missouri: 20,750 units · 335 per 100k residents MO Kentucky: 111,410 units · 2,462 per 100k residents KY West Virginia: 72,750 units · 4,110 per 100k residents WV Virginia: 17,850 units · 205 per 100k residents VA Maryland: 31,300 units · 506 per 100k residents MD Connecticut: 27,527 units · 761 per 100k residents CT Rhode Island: 6,120 units · 559 per 100k residents RI Arizona: 117,700 units · 1,584 per 100k residents AZ New Mexico: 70,850 units · 3,351 per 100k residents NM Kansas: 16,690 units · 568 per 100k residents KS Arkansas: 13,900 units · 453 per 100k residents AR Tennessee: 148,580 units · 2,085 per 100k residents TN North Carolina: 90,619 units · 836 per 100k residents NC South Carolina: 21,480 units · 400 per 100k residents SC Delaware: no data reported DE Oklahoma: 19,350 units · 477 per 100k residents OK Louisiana: 68,850 units · 1,505 per 100k residents LA Mississippi: 45,201 units · 1,537 per 100k residents MS Alabama: 35,200 units · 689 per 100k residents AL Georgia: 3,050 units · 27.7 per 100k residents GA D.C.: no data reported DC Hawaii: 2,350 units · 164 per 100k residents HI Texas: 31,200 units · 102 per 100k residents TX Florida: 253,680 units · 1,122 per 100k residents FL
Units reimbursed · per 100k residents
27.75,008
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Vermont 5,008 /100k
2 West Virginia 4,110 /100k
3 New Mexico 3,351 /100k
4 Maine 3,351 /100k
5 Colorado 2,554 /100k
6 Kentucky 2,462 /100k
7 Tennessee 2,085 /100k
8 Wyoming 2,072 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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.
← 42571-0432-79 · Micro 42571-0435-72 · Micro →
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.