Famotidine 4 mg/mL Injection, Solution — NDC 25021-756-10 (Billing 25021-0756-10)
This is a package of Famotidine 4 mg/mL Injection, Solution from Sagent Pharmaceuticals, marketed since Oct 2025 and currently FDA-listed, this package's marketing is listed to end Mar 2027. It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 25021-756-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 25021 labeler · 756 product · 10 package
- Package marketed since
- Oct 15, 2025
- Package marketing ended
- Mar 31, 2027
- Sample package
- No — commercial package
- Barcode (UPC-A, from the NDC)
- 3 2502175610 2
- FDA record last changed
- Jul 24, 2026
Other active recalls for Famotidine (different manufacturers) — 2 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 088013
- GCN: 58087
- HICL (First Databank): 004521
- AHFS class code: 04:92.00.00
- RxCUI (RxNorm): 2727402
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Histamine-2 Receptor Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗- It lowers stomach acid. It's used in the hospital for ulcers, GERD, or excess-acid conditions, especially when you can't take pills. It's typically used until you can switch to ora...
- Why am I getting famotidine through an IV?
- For adults it is generally given about every 12 hours through a vein. Your care team will set the exact dose and timing, which may be adjusted if your kidneys aren't working well.
- The common ones are headache, dizziness, constipation, and diarrhea. You may also notice brief irritation where the IV goes in. Tell your nurse about any of these.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Famotidine — tap one for details:
Famotidine may be associated with lower levels of 6 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 25021-0756-10 You're viewing this Main listing | 10 VIAL in 1 CARTON / 10 mL in 1 VIAL | 2025-10-15 | Mar 31, 2027 | Active |
| 25021-0756-50 25021-756-50 | 1 VIAL in 1 CARTON / 50 mL in 1 VIAL | 2025-10-15 | Feb 28, 2027 | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Famotidine 4 mg/mL Injection, Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Famotidine 4 mg/mLthis 25021-0756-10 | Sagent | 10 vials | — | — | FDA listed | — |
| Famotidine 4 mg/mL 25021-0755-05 | Sagent | 25 vials | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Famotidine Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 30KYC7MIAI
Aspartic acid is an amino acid used in pharmaceutical formulations as a pH buffer and to help stabilize active ingredients. It works to maintain the proper acidity level in the medicine.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Sagent Pharmaceuticals labeler code 25021
- Ketorolac Tromethamine 30 mg/mL Injection, Solution NDC 25021-701-01
- Acetaminophen 10 mg/mL Injection, Solution NDC 25021-705-82
- Pantoprazole Sodium 40 mg/10mL Injection, Powder, Lyophilized, For Solution NDC 25021-751-10
- Famotidine 10 mg/mL Injection, Solution NDC 25021-753-02
- Famotidine 10 mg/mL Injection, Solution NDC 25021-754-04
- Famotidine 4 mg/mL Injection, Solution NDC 25021-755-05
- ondansetron 2 mg/mL Injection, Solution NDC 25021-777-02
- Levetiracetam 500 mg/5mL Injection, Solution, Concentrate NDC 25021-780-05
- palonosetron hydrochloride .05 mg/mL Injection, Solution NDC 25021-783-05
- PROCHLORPERAZINE EDISYLATE 5 mg/mL Injection NDC 25021-790-02
- LACOSAMIDE 10 mg/mL Injection, Solution NDC 25021-791-20
- levetiracetam 5 mg/mL Injection, Solution NDC 25021-793-82
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Famotidine Injection is indicated for use in hospitalized adults, or as an alternative to oral famotidine 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 endoscopy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence. FAMOTIDINE Injection is a histamine-2 (H 2 ) receptor antagonist indicated: In hospitalized adults, or as an alternative to oral famotidine 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 endoscopy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of DU recurrence.
In hospitalized pediatric patients 1 year of age and older, or as an alternative to oral famotidine in pediatric patients 1 year of age and older, for the treatment of: peptic ulcer disease. Pediatric Patients 1 Year of Age and Older Famotidine Injection is indicated in hospitalized pediatric patients 1 year of age and older, or as an alternative to oral famotidine in pediatric patients 1 year of age and older, for the treatment of peptic ulcer disease.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administration Information ( 2.1 ) Famotidine Injection is intended for use in adult and pediatric hospitalized patients, or as an alternative to oral famotidine. Discontinue as soon as the patient is able to tolerate oral treatment and switch to an appropriate oral medication. Recommended Dosage ( 2.2 ) Adults: 20 mg every 12 hours.
For pathological hypersecretory conditions titrate the dosage to individual patient needs. Pediatric Patients 1 year of age and older: 0.25 mg/kg every 12 hours; titrate to a maximum of 0.5 mg/kg every 12 hours (up to maximum of 20 mg every 12 hours) based on clinical response and/or gastric pH determination and endoscopy. Administer as an intravenous injection over at least 2 minutes or an intravenous infusion over 15 minutes to 30 minutes.
Refer to the prescribing information for oral famotidine products for the recommended duration of famotidine treatment. Renal Impairment ( 2.3 ) See the full prescribing information for the recommended dosage for adult patients with moderate or severe renal impairment.
2.1Important Administration Information Famotidine Injection is intended for use in adult and pediatric hospitalized patients, or as an alternative to oral famotidine. Discontinue Famotidine Injection as soon as the patient is able to tolerate oral treatment and switch to an appropriate oral medication.
2.2Recommended Dosage in Adults and Pediatric Patients 1 Year of Age and Older The recommended dosage of Famotidine Injection in adults and pediatric patients 1 year of age and older is shown in Tables 1 and 2 , respectively. Administer Famotidine Injection as an intravenous injection over at least 2 minutes or as an intravenous infusion over 15 minutes to 30 minutes [see Dosage and Administration ( 2.4 )]. Refer to the prescribing information for oral famotidine products for the recommended duration of famotidine treatment.
Table 1. Recommended Dosage 1 of Famotidine Injection in Adults 1 Refer to the prescribing information for oral famotidine products for the recommended duration of famotidine treatment. Indication Recommended Dosage Active Duodenal Ulcer 20 mg every 12 hours Active Gastric Ulcer Symptomatic Nonerosive GERD Erosive Esophagitis Diagnosed by Endoscopy Reduction of the Risk of Duodenal Ulcer Recurrence Pathological Hypersecretory Conditions Starting dosage is 20 mg every 12 hours; titrate the dosage to individual patient needs Table 2.
Recommended Dosage 1 of Famotidine Injection in Pediatric Patients 1 Year of Age and Older 1 Refer to the prescribing information for oral famotidine products for the recommended duration of famotidine treatment. Indication Recommended Dosage Peptic Ulcer Disease 0.25 mg/kg every 12 hours (maximum 20 mg every 12 hours) Titrate to a maximum dosage of 0.5 mg/kg every 12 hours (maximum of 20 mg every 12 hours) based on clinical response and/or gastric pH determination and endoscopy.
2.3Recommended Dosage in Patients with Renal Impairment Adults The recommended dosage for adult patients with moderate to severe renal impairment is shown in Table 3 . Administer Famotidine Injection as an intravenous injection over at least 2 minutes or as an intravenous infusion over 15 minutes to 30 minutes [see Dosage and Administration ( 2.4 )]. Table 3.
Recommended Dosage 1 of Famotidine Injection in Adults with Renal Impairment 1 Refer to the prescribing information for oral famotidine products for the recommended duration of famotidine treatment. 2 The dosage required to treat pathological hypersecretory conditions may exceed the maximum doses evaluated in patients with impaired renal function. The risk for increased adverse reactions in renally impaired patients treated with Famotidine Injection for pathological hypersecretory conditions is unknown.
Indication Recommended Dosage Creatinine Clearance 30 to 60 mL/minute Creatinine Clearance less than 30 mL/minute Active Duodenal Ulcer 20 mg once daily 10 mg once daily Active Gastric Ul… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: a clear, colorless, solution supplied ready-to-use as: 20 mg/5 mL (4 mg/mL) single-dose vial 40 mg/10 mL (4 mg/mL) multi-dose vial 200 mg/50 mL (4 mg/mL) multi-dose vial Injection: 20 mg/5 mL (4 mg/mL) single-dose vial 40 mg/10 mL (4 mg/mL) multi-dose vial 200 mg/50 mL (4 mg/mL) multi-dose vial
⛔ Contraindications ▾
4 CONTRAINDICATIONS Famotidine Injection 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 ▾
5 WARNINGS AND PRECAUTIONS Central Nervous System (CNS) Adverse Reactions : Reported in elderly patients and patients with moderate and severe renal impairment; monitor elderly patients for CNS adverse reactions. ( 5.1 , 8.5 , 8.6 ) Concurrent GI Malignancy : Absence of GI symptoms does not preclude the presence of gastric malignancy; evaluate prior to initiating therapy. ( 5.2 ) Risk of Benzyl Alcohol Toxicity in Neonates : Famotidine Injection is not approved in neonates.
Serious and fatal adverse reactions have been reported in low-birth weight and preterm neonates who received benzyl-alcohol-containing drugs intravenously. The minimum amount of benzyl alcohol at which these serious adverse reactions may occur is not known. ( 5.3 )
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. Monitor elderly patients for CNS adverse reactions [see Use in Specific Populations ( 8.5 )] . Dosage adjustments are recommended in adult patients with moderate and severe renal impairment due to higher famotidine systemic exposure compared to patients with normal renal function [see Dosage and Administration ( 2.3 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 )].
5.2Concurrent Gastric Malignancy In adults, symptomatic response to therapy with Famotidine Injection 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 Injection.
5.3Risk of Benzyl Alcohol Toxicity in Neonates Famotidine Injection is not approved in neonates. Serious adverse reactions, including fatal reactions, of new onset or worsening metabolic acidosis that progressed to neurotoxicity, and in some cases gasping syndrome, have been reported in low-birth weight neonates (less than 2,500 grams) and preterm neonates (gestational age less than 34 weeks) who received benzyl alcohol (BA)-containing drugs intravenously. Gasping syndrome is a life-threatening condition in neonates caused by BA toxicity and is primarily characterized by multiorgan dysfunction secondary to metabolic acidosis, which leads to gasping respirations and death.
The minimum amount of BA at which these serious adverse reactions, including fatal reactions, may occur is not known (Famotidine Injection contains 3.6 mg of BA per mL) [see Use in Specific Populations ( 8.4 )] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions (>1%) are: headache, dizziness, constipation, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials 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 Injection has been established based on adequate and well-controlled studies of an oral famotidine product. 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 2,500 patients. A total of 1,442 patients were treated with oral 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.
Adverse reactions reported in ≥1% of patients treated with oral famotidine in clinical trials were: headache, dizziness, constipation, and diarrhea. The following other adverse reactions were reported in less than 1% of patients treated with oral famotidine in clinical trials: Body as a Whole : fever, asthenia, fatigue Cardiovascular : palpitations Gastrointestinal : cholestatic jaundice, 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 Respiratory : interstitial pneumonia Skin : pruritus, dry skin, flushing Special Senses : tinnitus, taste disorder Other : impotence Adverse reactions reported with oral famotidine may also occur with Famotidine Injection.
In addition, transient irritation at the injection site was reported with intravenous famotidine.
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 ▾
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. See the prescribing information for other drugs dependent on gastric pH for absorption. ( 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. See the prescribing information for other drugs dependent on gastric pH for absorption.
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 Injection. If concomitant use is necessary, monitor for hypotension, bradycardia or excessive drowsiness. Refer to the full prescribing information for tizanidine.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Renal Impairment : QT prolongation reported in patients with moderate and severe renal impairment. ( 2.3 , 8.6 )
8.1Pregnancy Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Reproductive studies have been performed in rats and rabbits at intravenous doses of up to 200 mg/kg/day, with no obvious adverse developmental effects (see Data ) . Famotidine Injection contains benzyl alcohol as a preservative [see How Supplied/Storage and Handling ( 16 )] .
Because benzyl alcohol is rapidly metabolized by a pregnant female, benzyl alcohol exposure in the fetus is unlikely. The 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.
8.2Lactation Risk Summary There are limited data available on the presence of famotidine in human breast milk following oral administration. There were no effects on the breastfed infant. There are no data on famotidine effects on milk production.
Famotidine Injection contains benzyl alcohol as a preservative. Because benzyl alcohol is rapidly metabolized by a lactating female, benzyl alcohol exposure in the breastfed neonate is unlikely. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Famotidine Injection and any potential adverse effects on the breastfed child from famotidine or from the underlying maternal condition.
8.4Pediatric Use Peptic Ulcer Disease The safety and effectiveness of Famotidine Injection have been established in pediatric patients 1 year to less than 17 years of age for the treatment of peptic ulcer disease in hospitalized patients or as an alternative to oral famotidine. Use of Famotidine Injection in this age group is supported by evidence from adequate and well-controlled studies of oral 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 ) and Clinical Pharmacology ( 12.2 , 12.3 )] .
A safe and effective dosage has not been established in pediatric patients 1 year to less than 17 years of age with renal impairment for the treatment of peptic ulcer disease. The safety and effectiveness of Famotidine Injection for the treatment of peptic ulcer disease in pediatric patients less than 1 year of age have not been established. Other Conditions The safety and effectiveness of Famotidine Injection for the treatment of symptomatic nonerosive GERD, erosive esophagitis due to GERD, pathological hypersecretory conditions and reduction of the risk of DU recurrence have not been established in pediatric patients.
Risk of Benzyl Alcohol Toxicity in Neonates Famotidine Injection is not approved for use in neonates. Serious adverse reactions, including fatal reactions, of new onset or worsening metabolic acidosis that progressed to neurotoxicity, and in some cases gasping syndrome, have been reported in low-birth weight neonates and preterm neonates who received benzyl alcohol (BA)-containing drugs intravenously. Gasping syndrome is a life-threatening condition in neonates caused by BA toxicity that is characterized by new onset or worsening metabolic acidosis with gradual neurological deterioratio… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Reproductive studies have been performed in rats and rabbits at intravenous doses of up to 200 mg/kg/day, with no obvious adverse developmental effects (see Data ) . Famotidine Injection contains benzyl alcohol as a preservative [see How Supplied/Storage and Handling ( 16 )] .
Because benzyl alcohol is rapidly metabolized by a pregnant female, benzyl alcohol exposure in the fetus is unlikely. The 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.
🧒 Pediatric Use ▾
8.4Pediatric Use Peptic Ulcer Disease The safety and effectiveness of Famotidine Injection have been established in pediatric patients 1 year to less than 17 years of age for the treatment of peptic ulcer disease in hospitalized patients or as an alternative to oral famotidine. Use of Famotidine Injection in this age group is supported by evidence from adequate and well-controlled studies of oral 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 ) and Clinical Pharmacology ( 12.2 , 12.3 )] .
A safe and effective dosage has not been established in pediatric patients 1 year to less than 17 years of age with renal impairment for the treatment of peptic ulcer disease. The safety and effectiveness of Famotidine Injection for the treatment of peptic ulcer disease in pediatric patients less than 1 year of age have not been established. Other Conditions The safety and effectiveness of Famotidine Injection for the treatment of symptomatic nonerosive GERD, erosive esophagitis due to GERD, pathological hypersecretory conditions and reduction of the risk of DU recurrence have not been established in pediatric patients.
Risk of Benzyl Alcohol Toxicity in Neonates Famotidine Injection is not approved for use in neonates. Serious adverse reactions, including fatal reactions, of new onset or worsening metabolic acidosis that progressed to neurotoxicity, and in some cases gasping syndrome, have been reported in low-birth weight neonates and preterm neonates who received benzyl alcohol (BA)-containing drugs intravenously. Gasping syndrome is a life-threatening condition in neonates caused by BA toxicity that is characterized by new onset or worsening metabolic acidosis with gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and kidney failure, hypotension, bradycardia, and gasping respirations followed by death.
In reported cases, BA in amounts of 99 to 234 mg/kg/day produced blood BA levels of 6.6 to 14.9 mg/dL, but the minimum amount of BA at which gasping syndrome may occur in neonates is not known (Famotidine Injection contains 3.6 mg of BA per mL) [see Warnings and Precautions ( 5.3 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 1,442 patients treated with oral famotidine 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 elderly patients, there are no clinically significant age-related changes in the pharmacokinetics of famotidine [see Clinical Pharmacology ( 12.3 )] .
In postmarketing experience, CNS adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine. Monitor elderly patients for CNS adverse reactions [see Warnings and Precautions ( 5.1 )] . Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to Famotidine Injection may be greater in elderly patients, particularly those with impaired renal function [see Dosage and Administration ( 2.3 ) and Use in Specific Populations ( 8.6 )].
🆘 Overdosage ▾
10 OVERDOSAGE Adverse reactions reported in cases of overdosage are similar to the adverse reactions reported with use of the recommended dosage [see Adverse Reactions ( 6 )]. In the event of overdosage, treatment should be symptomatic and supportive. In the event of overdosage, monitor the patient, and employ supportive therapy.
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. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Famotidine is a competitive inhibitor of histamine 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 basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After intravenous administration, the maximum effect was achieved within 30 minutes. Single intravenous doses of 20 mg inhibited nocturnal secretion for a period of 10 to 12 hours.
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 central nervous system (CNS), cardiovascular, respiratory or endocrine systems were not noted.
Also, no antiandrogenic 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 were evaluated in five pediatric patients 2 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 one study of adults ( Table 4 ). Table 4: Pharmacodynamics of Famotidine Using the Sigmoid E max Model a Using the sigmoid E max model, serum concentration of famotidine associated with 50% maximum gastric acid reduction. Values are presented as means ± SD EC 50 (ng/mL) a Pediatric Patients 26 ± 13 Data from one study a) Healthy adult subjects 26.5 ± 10.3 b) Adult patients with upper GI bleeding 18.7 ±
10.8Five published studies ( Table 5 ) examined the effect of famotidine on gastric pH and duration of acid suppression in pediatric patients. While each study had a different design, acid suppression data over time are summarized as follows: Table 5: Effect of Intravenous Famotidine on Gastric pH and Duration of Acid Suppression in Pediatric Patients 1 to 15 Years of Age a Values reported in published literature b Means ± SD c Mean (95% confidence interval) Dosage Regimen Number of Patients Effect on Gastric Acid a Patient Age Range 0.3 mg/kg, single-dose 6 gastric pH >3.5 for 8.7 ± 4.7 b hours 2 to 7 years 0.5 mg/kg, single-dose 9 a >2 pH unit increase above baseline ingastric pH for >8 hours 2 to 13 years 0.5 mg/kg twice daily 4 gastric pH >5 for 13.5 ± 1.8 b hours 6 to 15 years
12.3Pharmacokinetics Plasma levels after multiple doses 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.
Sixty-five to 70% of an intravenous dose are 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/minutes, indicating some tubular excretion. Specific Populations Pediatric Patients Table 6 presents pharmacokinetic data for famotidine administered intravenously.
Areas under the curve (AUCs) are normalized to a 0.5 mg/kg intravenous dose for pediatric patients 1 to 15 years of age and compared with an extrapolated 40 mg intravenous dose in adults. Extrapolation is based on results obtained with a 20 mg intravenous adult dose). The pharmacokinetic parameters for pediatric patients, aged 1 year to 15 years, are comparable to those obtained for adults.
Table 6: Pharmacokinetic Parameters a of Intravenous Famotidine In Pediatric Patients 1 Year to 15 Years of Age and Adults a Values are presented as mea… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Famotidine is a competitive inhibitor of histamine 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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Famotidine Injection is a clear, colorless, sterile solution supplied premixed and ready-to-use as follows: Famotidine Injection (Preservative-free) NDC (4 mg per mL) Package Factor 25021-755-05 20 mg per 5 mL Single-Dose Vial 25 vials per carton Famotidine Injection (Preservative) NDC (4 mg per mL) Package Factor 25021-756-10 40 mg per 10 mL Multi-Dose Vial 10 vials per carton 25021-756-50 200 mg per 50 mL Multi-Dose Vial 1 vial per carton Storage Conditions Store at room temperature between 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] If not used immediately, store diluted solutions of Famotidine Injection between 2° and 8°C (36° and 46°F) for up to 48 hours [see Dosage and Administration ( 2.4 )] .
Do not freeze. Protect from light. Retain in carton until time of use.
The container closure is not made with natural rubber latex.
📦 Storage and Handling ▾
Storage Conditions Store at room temperature between 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] If not used immediately, store diluted solutions of Famotidine Injection between 2° and 8°C (36° and 46°F) for up to 48 hours [see Dosage and Administration ( 2.4 )] . Do not freeze. Protect from light.
Retain in carton until time of use. The container closure is not made with natural rubber latex.
📋 Description ▾
11 DESCRIPTION The active ingredient in Famotidine Injection is a histamine H 2 -receptor antagonist. Famotidine, USP 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 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. Famotidine Injection is supplied as a premixed, ready-to-use, sterile solution for intravenous injection. Each mL contains 4 mg of famotidine and the following inactive ingredients: L-aspartic acid 1.6 mg, mannitol 8 mg, sodium chloride 7 mg, and Water for Injection q.s.
1 mL. The multiple-dose vials of 10 mL and 50 mL also contain benzyl alcohol 0.36% (3.6 mg per mL) added as a preservative. The pH ranges for all three concentrations range from 5.7 to 6.4 and may have been adjusted with sodium hydroxide.
Figure
💬 Information for Patients ▾
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. Risk of Benzyl Alcohol Toxicity in Neonates Inform caregivers that serious adverse reactions, including fatal reactions, have been reported in neonates who received drugs containing benzyl alcohol intravenously. Inform the healthcare provider if neurologic, hematologic or cardiac adverse reactions occur [see Warnings and Precautions ( 5.3 )]. sagent ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60173 (USA) Made in India ©2025 Sagent Pharmaceuticals
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Plasma levels after multiple doses 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.
Sixty-five to 70% of an intravenous dose are 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/minutes, indicating some tubular excretion. Specific Populations Pediatric Patients Table 6 presents pharmacokinetic data for famotidine administered intravenously.
Areas under the curve (AUCs) are normalized to a 0.5 mg/kg intravenous dose for pediatric patients 1 to 15 years of age and compared with an extrapolated 40 mg intravenous dose in adults. Extrapolation is based on results obtained with a 20 mg intravenous adult dose). The pharmacokinetic parameters for pediatric patients, aged 1 year to 15 years, are comparable to those obtained for adults.
Table 6: Pharmacokinetic Parameters a of Intravenous Famotidine In Pediatric Patients 1 Year to 15 Years of Age and Adults a Values are presented as means ± SD unless indicated otherwise b Mean value only c Single center study d Multicenter study Age (N=number of patients) Area Under the Curve (AUC) (ng-hr/mL) Total Clearance (Cl) (L/hr/kg) Volume of Distribution (V d ) (L/kg) Elimination Half-Life (T 1/2 ) (hours) 1 to 11 years (N=20) 1089 ± 834 0.54 ± 0.34 2.07 ± 1.49 3.38 ± 2.6 11 to 15 years (N=6) 1140 ± 320 0.48 ± 0.14 1.5 ± 0.4 2.3 ±
0.4Adults (N=16) 1726 b 0.39 ± 0.14 1.3 ± 0.2 2.83 ±
0.99Geriatric Patients In elderly patients, there are no clinically significant age-related changes in the pharmacokinetics of famotidine. However, in elderly patients with decreased renal function, the clearance of the drug may be decreased [see Use in Specific Populations ( 8.5 )] . 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/minute), the AUC of famotidine increased at least 2-fold [see Dosage and Administration ( 2.3 ) and 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 (1500 mg), an inhibitor of OAT1 and OAT3, with a single oral 20 mg dose of famotidine in eight 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 [see Drug Interaction ( 7.2 )]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Adults Famotidine inhibited basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After intravenous administration, the maximum effect was achieved within 30 minutes. Single intravenous doses of 20 mg inhibited nocturnal secretion for a period of 10 to 12 hours.
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 central nervous system (CNS), cardiovascular, respiratory or endocrine systems were not noted.
Also, no antiandrogenic 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 were evaluated in five pediatric patients 2 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 one study of adults ( Table 4 ). Table 4: Pharmacodynamics of Famotidine Using the Sigmoid E max Model a Using the sigmoid E max model, serum concentration of famotidine associated with 50% maximum gastric acid reduction. Values are presented as means ± SD EC 50 (ng/mL) a Pediatric Patients 26 ± 13 Data from one study a) Healthy adult subjects 26.5 ± 10.3 b) Adult patients with upper GI bleeding 18.7 ±
10.8Five published studies ( Table 5 ) examined the effect of famotidine on gastric pH and duration of acid suppression in pediatric patients. While each study had a different design, acid suppression data over time are summarized as follows: Table 5: Effect of Intravenous Famotidine on Gastric pH and Duration of Acid Suppression in Pediatric Patients 1 to 15 Years of Age a Values reported in published literature b Means ± SD c Mean (95% confidence interval) Dosage Regimen Number of Patients Effect on Gastric Acid a Patient Age Range 0.3 mg/kg, single-dose 6 gastric pH >3.5 for 8.7 ± 4.7 b hours 2 to 7 years 0.5 mg/kg, single-dose 9 a >2 pH unit increase above baseline ingastric pH for >8 hours 2 to 13 years 0.5 mg/kg twice daily 4 gastric pH >5 for 13.5 ± 1.8 b hours 6 to 15 years
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of intravenously administered famotidine has not been determined. In a 106-week study in rats and a 92-week study in mice given oral doses of up to 2,000 mg/kg/day there was no evidence of carcinogenic potential for famotidine. Famotidine was negative in the bacterial 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 or intravenous doses of up to 200 mg/kg/day, fertility and reproductive performance were not affected.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of intravenously administered famotidine has not been determined. In a 106-week study in rats and a 92-week study in mice given oral doses of up to 2,000 mg/kg/day there was no evidence of carcinogenic potential for famotidine. Famotidine was negative in the bacterial 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 or intravenous doses of up to 200 mg/kg/day, fertility and reproductive performance were not affected.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label NDC 25021-755-05 Rx only Famotidine Injection 20 mg per 5 mL (4 mg per mL) For Intravenous Use 5 mL Single-Dose Vial Discard Unused Portion PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label NDC 25021-756-10 Rx only Famotidine Injection 40 mg per 10 mL (4 mg per mL) For Intravenous Use 10 mL Multi-Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label NDC 25021-756-50 Rx only Famotidine Injection 200 mg per 50 mL (4 mg per mL) For Intravenous Use 50 mL Multi-Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
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