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Famotidine 20 mg/50mL Injection, Solution — NDC 00338-5197-41 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Famotidine 20 mg/50mL Injection, Solution — NDC 0338-5197-41 (Billing 00338-5197-41)

by Baxter Healthcare Corporation · 12 BAG in 1 CARTON / 50 mL in 1 BAG

This is a package of Famotidine 20 mg/50mL Injection, Solution from Baxter Healthcare Corporation, marketed since May 2001 and currently FDA-listed. It is this product's only package size.

NDC 00338-5197-41
🏷️ FDA NDC (as labeled) 0338-5197-41 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0338-5197-41 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0338 labeler · 5197 product · 41 package
Package marketed since
May 10, 2001
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0338519741 0
Medicaid fills, this package
8,746 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0809-2026
Lots / codes: Lot # NC188586, Exp Date: 02/28/2027; Lot # NC188913, Exp Date: 3/9/2027. · reported Sep 9, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Famotidine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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) 0338-5197-41
Product NDC 0338-5197
11-digit billing NDC 00338519741
NCPDP billing unit ML — per mL (volume)
RxCUI 199739
UNII 5QZO15J2Z8
Application # ANDA075591
SPL Set ID 97c33213-f415-4718-8466-9aa50371af70
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 2001-05-10
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance FAMOTIDINE

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

GPI-14 49200030112020
GPI class Famotidine Premixed
GCN Seq No 021732
GCN 46411
HICL code 035107
Ingredient (HICL) Famotidine In Nacl,Iso-Osm/Pf
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 20 MG PIGGYBACK
FDB brand name Famotidine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 021732
  • GCN: 46411
  • GPI-14 (Medi-Span): 49200030112020
  • HICL (First Databank): 035107
  • AHFS class code: 04:92.00.00
  • RxCUI (RxNorm): 199739
Why two NDCs? The FDA registers this code as 0338-5197-41 — a 4-4-2 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 labeler segment → 00338-5197-41. 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 20 MG PIGGYBACK Ingredient Famotidine In Nacl,Iso-Osm/Pf
📖 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $2.07 $1,242.72 / 600 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1308 $0.008 / J1308 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)0338-5197-41
11-digit billing NDC00338-5197-41
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1308
DescriptorINJECTION, FAMOTIDINE, 0.25 MG
Billing units / pkg1.6 units
How the units are derivedThis package is 50 ML; the HCPCS unit is 0.25 MG, so one package = 1.6 billing units.
Medicare Part B spend (2026 (Q1))$37,834 · 51,954 claims · $0.73 per claim (all NDCs under J1308)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00338-5197-41 You're viewing this Main listing 12 BAG in 1 CARTON / 50 mL in 1 BAG 2001-05-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Famotidine 20 mg/50mLthis 00338-5197-41 Baxter 50 ml — — 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

🏛️
2001
On the market since
May 2001
📍
2026
Currently FDA-listed
25 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Famotidine 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.

  • 6.8 mg / 50 mL 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.
  • 450 mg / 50 mL 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.
  • 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.
  • 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.

4 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

LabelerBaxter Healthcare Corporation
Application holderBAXTER HEALTHCARE CORP
FDA applicationANDA075591 (ANDA)
Labeler code00338
First marketedMay 2001
Product typeHuman Prescription Drug
Portfolio285 products on file

More NDCs from Baxter Healthcare Corporation labeler code 00338

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Famotidine Injection is supplied as a premixed solution in GALAXY plastic containers and is intended for intravenous use only. Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions: 1. Short term treatment of active duodenal ulcer.

Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. 2.

Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year. 3.

Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.

4. Short term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ).

Famotidine is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ). 5. Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ).

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD) See PRECAUTIONS, Pediatric Patients <1 year of age . The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied. Dosage for Pediatric Patients 1–16 years of age See PRECAUTIONS, Pediatric Patients 1-16 years of age .

The studies described in PRECAUTIONS, Pediatric Patients 1–16 years of age suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy.

Published uncontrolled studies in pediatric patients 1-16 years of age have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients.

Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of Famotidine Injection may be reduced to half the dose, or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response. Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult intravenous dose is 20 mg q 12 h. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated.

In some patients, a higher starting dose may be required. Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome. Famotidine Injection Famotidine Injection, supplied in GALAXY containers, is a 50 mL iso-osmotic solution premixed with 0.9% sodium chloride for administration as an infusion over a 15-30 minute period.

This premixed solution is for intravenous use only using sterile equipment.

⛔ Contraindications 38 words ▾

CONTRAINDICATIONS Hypersensitivity to any component of this product. Cross sensitivity in this class of compounds has been observed. Therefore, Famotidine Injection should not be administered to patients with a history of hypersensitivity to other H 2 -receptor antagonists.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The adverse reactions listed below have been reported during domestic and international clinical trials in approximately 2500 patients. In those controlled clinical trials in which famotidine tablets were compared to placebo, the incidence of adverse experiences in the group which received famotidine tablets, 40 mg at bedtime, was similar to that in the placebo group. The following adverse reactions have been reported to occur in more than 1% of patients on therapy with famotidine in controlled clinical trials, and may be causally related to the drug: headache (4.7%), dizziness (1.3%), constipation (1.2%) and diarrhea (1.7%).

The following other adverse reactions have been reported infrequently in clinical trials or since the drug was marketed. The relationship to therapy with famotidine has been unclear in many cases. Within each category the adverse reactions are listed in order of decreasing severity: Body as a Whole : fever, asthenia, fatigue Cardiovascular : arrhythmia, AV block, palpitation, prolong QT interval.

Gastrointestinal : cholestatic jaundice, hepatitis, liver enzyme abnormalities, vomiting, nausea, abdominal discomfort, anorexia, dry mouth Hematologic : rare cases of agranulocytosis, pancytopenia, leukopenia, thrombocytopenia Hypersensitivity : anaphylaxis, angioedema, orbital or facial edema, urticaria, rash, conjunctival injection Musculoskeletal : musculoskeletal pain including muscle cramps, arthralgia Nervous System/Psychiatric : grand mal seizure; psychic disturbances, which were reversible in cases for which follow-up was obtained, including hallucinations, confusion, agitation, depression, anxiety, decreased libido; paresthesia; insomnia; somnolence.

Convulsions, in patients with impaired renal function, have been reported. Respiratory : bronchospasm, interstitial pneumonia Skin : toxic epidermal necrolysis/Stevens Johnson syndrome, alopecia, acne, pruritus, dry skin, flushing Special Senses : tinnitus, taste disorder Other : rare cases of impotence and rare cases of gynecomastia have been reported; however, in controlled clinical trials, the incidences were not greater than those seen with placebo. The adverse reactions reported for famotidine tablets may also occur with famotidine for oral suspension, famotidine injection in Galaxy plastic container, and famotidine injection.

In addition, transient irritation at the injection site has been observed with famotidine injection. Pediatric Patients In a clinical study in 35 pediatric patients <1 year of age with GERD symptoms [e.g., vomiting (spitting up), irritability (fussing)], agitation was observed in 5 patients on famotidine that resolved when the medication was discontinued.

🔄 Drug Interactions 107 words ▾

Drug Interactions Drugs 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. Tizanidine (CYP1A2 Substrate) Although not studied clinically, famotidine is considered a weak CYP1A2 inhibitor.

Concomitant use of tizanidine, a CYP1A2 substrate, with famotidine may lead to increased exposure of tizanidine and adverse reactions of hypotension, bradycardia or excessive drowsiness. Avoid concomitant use with famotidine. If use is clinically necessary, refer to the full prescribing information for tizanidine for dosage information.

🤰 Pregnancy 121 words ▾

Pregnancy 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 I.V. 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 (250 times the usual human dose) 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 ~3 min read ▾

CLINICAL PHARMACOLOGY IN PEDIATRIC PATIENTS Pharmacokinetics Table 6 presents pharmacokinetic data from clinical trials and a published study in pediatric patients (<1 year of age; N=27) given famotidine I.V. 0.5 mg/kg and from published studies of small numbers of pediatric patients (1-15 years of age) given famotidine intravenously. Areas under the curve (AUCs) are normalized to a dose of 0.5 mg/kg I.V. for pediatric patients 1-15 years of age and compared with an extrapolated 40 mg intravenous dose in adults (extrapolation based on results obtained with a 20 mg I.V. adult dose).

Table 6. Pharmacokinetic Parameters Values are presented as means ± SD unless indicated otherwise. of Intravenous Famotidine 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) 0-1 month Single center study. (N=10) NA 0.13 ± 0.06 1.4 ± 0.4 10.5 ± 5.4 0-3 months Multicenter study.

(N=6) 2688 ± 847 0.21 ± 0.06 1.8 ± 0.3 8.1 ± 3.5 >3-12 months (N=11) 1160 ± 474 0.49 ± 0.17 2.3 ± 0.7 4.5 ± 1.1 1-11 yrs (N=20) 1089 ± 834 0.54 ± 0.34 2.07 ± 1.49 3.38 ± 2.60 11-15 yrs (N=6) 1140 ± 320 0.48 ± 0.14 1.5 ± 0.4 2.3 ±

0.4Adult (N=16) 1726 Mean value only. 0.39 ± 0.14 1.3 ± 0.2 2.83 ±

0.99Plasma clearance is reduced and elimination half-life is prolonged in pediatric patients 0-3 months of age compared to older pediatric patients. The pharmacokinetic parameters for pediatric patients, ages >3 months-15 years, are comparable to those obtained for adults. Bioavailability studies of 8 pediatric patients (11-15 years of age) showed a mean oral bioavailability of 0.5 compared to adult values of 0.42 to 0.49.

Oral doses of 0.5 mg/kg achieved AUCs of 645 ± 249 ng-hr/mL and 580 ± 60 ng-hr/mL in pediatric patients <1 year of age (N=5) and in pediatric patients 11-15 years of age, respectively, compared to 482 ± 181 ng-hr/mL in adults treated with 40 mg orally. Pharmacodynamics Pharmacodynamics of famotidine were evaluated in 5 pediatric patients 2-13 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 7).

Table 7. Pharmacodynamics of famotidine using the sigmoid E max model EC 50 (ng/mL) Serum concentration of famotidine associated with 50% maximum gastric acid reduction. Values are presented as means ± SD.

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 8) 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 8. Dosage Route Effect Values reported in published literature.

Number of Patients ( age range ) 0.5 mg/kg, single dose I.V. gastric pH >4 for 19.5 hours (17.3, 21.8) Mean (95% confidence interval). 11 (5-19 days) 0.3 mg/kg; single dose I.V. gastric pH >3.5 for 8.7 ±

4.7Mean ± SD. hours 6 (2-7 years) 0.4-0.8 mg/kg I.V. gastric pH >4 for 6-9 hours 18 (2-69 months) 0.5 mg/kg, single dose I.V. a >2 pH unit increase above baseline in gastric pH for >8 hours 9 (2-13 years) 0.5 mg/kg b.i.d. I.V. gastric pH >5 for 13.5 ± 1.8 hours 4 (6-15 years) 0.5 mg/kg b.i.d. oral gastric pH >5 for 5.0 ± 1.1 hours 4 (11-15 years) The duration of effect of famotidine I.V. 0.5 mg/kg on gastric pH and acid suppression was shown in one study to be longer in pediatric patients <1 month of age than in older pediatric patients.

This longer duration of gastric acid suppression is consistent with the decreased clearance in pediatric patients <3 months of age (see Table 6 ).

🧓 Geriatric Use 148 words ▾

Geriatric Use Of the 4,966 subjects in clinical studies who were treated with famotidine, 488 subjects (9.8%) were 65 and older, and 88 subjects (1.7%) were greater than 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. In post marketing experience, CNS adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine (see WARNINGS).

Famotidine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, monitor renal function. Dosage adjustment in the case of moderate or severe renal impairment is necessary (see PRECAUTIONS, Patients with Moderate or Severe Renal Insufficiency and DOSAGE AND ADMINISTRATION, Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency ).

🆘 Overdosage 211 words ▾

OVERDOSAGE The adverse reactions in overdose cases are similar to the adverse reactions encountered in normal clinical experience (see ADVERSE REACTIONS ). Oral doses of up to 640 mg/day have been given to adult patients with pathological hypersecretory conditions with no serious adverse effects. In the event of overdosage, treatment should be symptomatic and supportive.

In the event of overdosage, 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 a limited experience on the usefulness of hemodialysis as a treatment for famotidine overdosage.

The intravenous LD 50 of famotidine for mice and rats ranged from 254-563 mg/kg and the minimum lethal single I.V. dose in dogs was approximately 300 mg/kg. Signs of acute intoxication in I.V. treated dogs were emesis, restlessness, pallor of mucous membranes or redness of mouth and ears, hypotension, tachycardia and collapse. The oral LD 50 of famotidine in male and female rats and mice was greater than 3000 mg/kg and the minimum lethal acute oral dose in dogs exceeded 2000 mg/kg.

Famotidine did not produce overt effects at high oral doses in mice, rats, cats and dogs, but induced significant anorexia and growth depression in rabbits starting with 200 mg/kg/day orally.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY IN ADULTS GI Effects 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.

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

After intravenous administration, the maximum effect was achieved within 30 minutes. Single intravenous doses of 10 and 20 mg inhibited nocturnal secretion for a period of 10 to 12 hours. The 20 mg dose was associated with the longest duration of action in most subjects.

Single evening oral doses of 20 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 6-8 hours. There was no cumulative effect with repeated doses. The nocturnal intragastric pH was raised by evening doses of 20 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 or 40 mg of famotidine was raised to about 5. Famotidine had little or no effect on fasting or postprandial serum gastrin levels. Gastric emptying and exocrine pancreatic function were not affected by famotidine.

Other Effects Systemic effects of famotidine in the central nervous system (CNS), cardiovascular, respiratory or endocrine systems were not noted in clinical pharmacology studies. Also, no antiandrogenic effects were noted (see ADVERSE REACTIONS ). Serum hormone levels, including prolactin, cortisol, thyroxine (T 4 ), and testosterone, were not altered after treatment with famotidine.

Pharmacokinetics Orally administered famotidine is incompletely absorbed and its bioavailability is 40-45%. Famotidine undergoes minimal first-pass metabolism. After oral doses, peak plasma levels occur in 1-3 hours.

Plasma levels after multiple doses are similar to those after single doses. Fifteen to 20% of famotidine in plasma is protein bound. Famotidine has an elimination half-life of 2.5-3.5 hours.

Famotidine is eliminated by renal (65-70%) and metabolic (30-35%) routes. Renal clearance is 250-450 mL/min, indicating some tubular excretion. Twenty-five to 30% of an oral dose and 65-70% of an intravenous dose are recovered in the urine as unchanged compound.

The only metabolite identified in man is the S-oxide. There is a close relationship between creatinine clearance values and the elimination half-life of famotidine. In patients with severe renal insufficiency, i.e., creatinine clearance less than 10 mL/min, the elimination half-life of famotidine may exceed 20 hours and adjustment of dose or dosing intervals in moderate and severe renal insufficiency may be necessary (see PRECAUTIONS , DOSAGE AND ADMINISTRATION ).

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 PRECAUTIONS, Geriatric Use ). Drug Interaction Studies Human Organic Anion Transporter (OAT) 1 and 3: In vit… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 92 words ▾

HOW SUPPLIED FOR INTRAVENOUS USE ONLY Famotidine Injection containing 20 mg of famotidine per 50 mL is a clear, non-preserved, sterile solution premixed in a vehicle made iso-osmotic with sodium chloride. Famotidine Injection is supplied in a carton of 12 x 50 mL single dose GALAXY plastic containers as follows: 2G3424 50 mL container NDC 0338-5197-41 Storage Store Famotidine Injection in GALAXY containers at room temperature (25°C/77°F). Exposure of the premixed product to excessive heat should be avoided.

Brief exposure to temperatures up to 35°C (95°F) does not adversely affect the product.

📦 Storage and Handling 36 words ▾

Storage Store Famotidine Injection in GALAXY containers at room temperature (25°C/77°F). Exposure of the premixed product to excessive heat should be avoided. Brief exposure to temperatures up to 35°C (95°F) does not adversely affect the product.

📋 Description 219 words ▾

DESCRIPTION The active ingredient in Famotidine Injection is a histamine 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 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 sterile solution, for intravenous use only, in plastic single dose GALAXY containers. Each 50 mL of the premixed, iso-osmotic intravenous injection contains 20 mg Famotidine, USP, and the following inactive ingredients: L-aspartic acid 6.8 mg, sodium chloride, USP, 450 mg, and Water for Injection.

The pH ranges from 5.7 to 6.4 and may have been adjusted with additional L-aspartic acid and/or with sodium hydroxide. The GALAXY plastic container is fabricated from a specially designed multilayer plastic. Solutions are in contact with the polyethylene layer of the container and can leach out certain chemical components of the plastic in very small amounts within the expiration period.

The suitability and safety of the plastic have been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies. Famotidine Structural Formula

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Symptomatic response to therapy with famotidine does not preclude the presence of gastric malignancy. Patients with Moderate or Severe Renal Insufficiency CNS adverse reactions have been reported in elderly patients and patients with moderate and severe renal insufficiency. Prolonged QT intervals have also been reported in patients with moderate and severe renal insufficiency.

Longer intervals between doses or lower doses may need to be used in adult and pediatric patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency to adjust for the longer elimination half-life of famotidine (see CLINICAL PHARMACOLOGY IN ADULTS , DOSAGE AND ADMINISTRATION ). Drug Interactions Drugs 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. Tizanidine (CYP1A2 Substrate) Although not studied clinically, famotidine is considered a weak CYP1A2 inhibitor. Concomitant use of tizanidine, a CYP1A2 substrate, with famotidine may lead to increased exposure of tizanidine and adverse reactions of hypotension, bradycardia or excessive drowsiness.

Avoid concomitant use with famotidine. If use is clinically necessary, refer to the full prescribing information for tizanidine for dosage information. Carcinogenesis, Mutagenesis, Impairment of Fertility In a 106 week study in rats and a 92 week study in mice given oral doses of up to 2000 mg/kg/day (approximately 2500 times the recommended human dose for active duodenal ulcer), 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 or intravenous doses of up to 200 mg/kg/day, fertility and reproductive performance were not affected.

Pregnancy 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 I.V. 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 (250 times the usual human dose) 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. Nursing Mothers Studies performed in lactating rats have shown that famotidine is secreted into breast milk.

Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of at least 600 times the usual human dose. Famotidine is detectable in human milk. Because of the potential for serious adverse reactions in nursing infants from famotidine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Patients <1 year of age Use of famotidine in pediatric patients <1 year of age is supported by evidence from adequate and well-controlled studies of famotidine in adults, and by the following studies in pediatric patients <1 year of age. Two pharmacokinetic studies in pediatric patients <1 year of age (N=48) demonstrated that clearance of famotidine in patients >3 months to 1 year of age is si… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 83 words ▾

Nursing Mothers Studies performed in lactating rats have shown that famotidine is secreted into breast milk. Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of at least 600 times the usual human dose. Famotidine is detectable in human milk.

Because of the potential for serious adverse reactions in nursing infants from famotidine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics 202 words ▾

Pharmacokinetics Orally administered famotidine is incompletely absorbed and its bioavailability is 40-45%. Famotidine undergoes minimal first-pass metabolism. After oral doses, peak plasma levels occur in 1-3 hours.

Plasma levels after multiple doses are similar to those after single doses. Fifteen to 20% of famotidine in plasma is protein bound. Famotidine has an elimination half-life of 2.5-3.5 hours.

Famotidine is eliminated by renal (65-70%) and metabolic (30-35%) routes. Renal clearance is 250-450 mL/min, indicating some tubular excretion. Twenty-five to 30% of an oral dose and 65-70% of an intravenous dose are recovered in the urine as unchanged compound.

The only metabolite identified in man is the S-oxide. There is a close relationship between creatinine clearance values and the elimination half-life of famotidine. In patients with severe renal insufficiency, i.e., creatinine clearance less than 10 mL/min, the elimination half-life of famotidine may exceed 20 hours and adjustment of dose or dosing intervals in moderate and severe renal insufficiency may be necessary (see PRECAUTIONS , DOSAGE AND ADMINISTRATION ).

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 PRECAUTIONS, Geriatric Use ).

🧬 Pharmacodynamics ~1 min read ▾

Pharmacodynamics Pharmacodynamics of famotidine were evaluated in 5 pediatric patients 2-13 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 7). Table 7.

Pharmacodynamics of famotidine using the sigmoid E max model EC 50 (ng/mL) Serum concentration of famotidine associated with 50% maximum gastric acid reduction. Values are presented as means ± SD. 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 8) 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 8. Dosage Route Effect Values reported in published literature.

Number of Patients ( age range ) 0.5 mg/kg, single dose I.V. gastric pH >4 for 19.5 hours (17.3, 21.8) Mean (95% confidence interval). 11 (5-19 days) 0.3 mg/kg; single dose I.V. gastric pH >3.5 for 8.7 ±

4.7Mean ± SD. hours 6 (2-7 years) 0.4-0.8 mg/kg I.V. gastric pH >4 for 6-9 hours 18 (2-69 months) 0.5 mg/kg, single dose I.V. a >2 pH unit increase above baseline in gastric pH for >8 hours 9 (2-13 years) 0.5 mg/kg b.i.d. I.V. gastric pH >5 for 13.5 ± 1.8 hours 4 (6-15 years) 0.5 mg/kg b.i.d. oral gastric pH >5 for 5.0 ± 1.1 hours 4 (11-15 years) The duration of effect of famotidine I.V. 0.5 mg/kg on gastric pH and acid suppression was shown in one study to be longer in pediatric patients <1 month of age than in older pediatric patients.

This longer duration of gastric acid suppression is consistent with the decreased clearance in pediatric patients <3 months of age (see Table 6 ).

🔬 Clinical Studies 20 words ▾

CLINICAL STUDIES The majority of clinical study experience involved oral administration of famotidine tablets, and is provided herein for reference.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 126 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility In a 106 week study in rats and a 92 week study in mice given oral doses of up to 2000 mg/kg/day (approximately 2500 times the recommended human dose for active duodenal ulcer), 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 or intravenous doses of up to 200 mg/kg/day, fertility and reproductive performance were not affected.

📄 Package Label / Principal Display Panel ~2 min read ▾

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL Container Label Baxter Famotidine Injection 20 mg Rx only GALAXY Single Dose Container 50 mL Iso-osmotic NDC 0338-5197-41 Code 2G3424 Sterile Nonpyrogenic Each 50 mL contains: 20 mg famotidine, USP, 450 mg sodium chloride, USP, and 6.8 mg L-aspartic acid. pH may have been adjusted with additional L-aspartic acid and/or sodium hydroxide. pH 5.7 to

6.4Usual Dosage: Intravenously as directed by a physician. See package insert. Cautions: Do not add supplementary medication.

Must not be used in series connections. Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired.

Do not use unless solution is clear. Recommended storage: Room temperature (25°C/77°F). Avoid excessive heat.

Brief exposure up to 35°C/95°F does not adversely affect the product. ______________________________________________________________________ Baxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation Deerfield, IL 60015 USA 07-34-00-2281 Carton Label Recommended storage: Room temperature (25°C/77°F). Avoid excessive heat.

Brief exposure up to 35°C/95°F does not adversely affect the product. Baxter and GALAXY are trademarks of Baxter International Inc. 07-04-00-1261 07-04-00-1261 Recommended storage: Room temperature (25°C/77°F).

Avoid excessive heat. Brief exposure up to 35°C/95°F does not adversely affect the product. Baxter and GALAXY are trademarks of Baxter International Inc.

07-04-00-1261 07-04-00-1261 Baxter NDC 0338-5197-41 Famotidine Injection Rx only 20 mg Code 2G3424 12 x 50 mL Single Dose Containers Iso-osmotic Recommended storage: Room temperature (25°C/77°F) Baxter Healthcare Corporation Deerfield, IL 60015 USA *FOR BAR CODE POSITION ONLY (01) 20303385197414 Baxter NDC 0338-5197-41 Famotidine Injection Rx only 20 mg Code 2G3424 12 x 50 mL Single Dose Containers Iso-osmotic Recommended storage: Room temperature (25°C/77°F) Baxter Healthcare Corporation Deerfield, IL 60015 USA *FOR BAR CODE POSITION ONLY (01) 20303385197414 GALAXY Container Sterile Nonpyrogenic Each 50 mL contains: 20 mg famotidine, USP, 450 mg sodium chloride, USP, and 6.8 mg L-aspartic acid. pH may have been adjusted with additional L-aspartic acid and/or sodium hydroxide. pH 5.7 to

6.4Usual Dosage: Intravenously as directed by physician. See package insert. Cautions: Do not add supplementary medication.

Must not be used in series connections. Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired.

Do not use unless solution is clear. GALAXY Container Sterile Nonpyrogenic Each 50 mL contains: 20 mg famotidine, USP, 450 mg sodium chloride, USP, and 6.8 mg L-aspartic acid. pH may have been adjusted with additional L-aspartic acid and/or sodium hydroxide. pH 5.7 to

6.4Usual Dosage: Intravenously as directed by physician. See package insert. Cautions: Do not add supplementary medication.

Must not be used in series connections. Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired.

Do not use unless solution is clear. Famotidine container label panel 1 of 2 Famotidine container label panel 2 of 2 Famotidine carton label panel 1 of 3 Famotidine carton label NDC 0338-5197-41 panel 2 of 3 Famotidine carton label NDC 0338-5197-41 panel 3 of 3

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
8.7K
Units reimbursed last 4 qtrs
542.4K
Gross reimbursed last 4 qtrs
$1.12M
Avg / prescription
$128.46
Avg / unit
$2.0712
Latest quarter Q1 2026
1.3KRx
Fee-for-service vs managed care ⓘ
90% MCO
Fee-for-service · 903 Rx Managed care · 7,843 Rx
State Medicaid map
Alaska: no data reported AK Maine: 924 units · 66.2 per 100k residents ME Washington: 860 units · 11.0 per 100k residents WA Idaho: no data reported ID Montana: 6,201 units · 548 per 100k residents MT North Dakota: no data reported ND Minnesota: 3,168 units · 55.2 per 100k residents MN Wisconsin: no data reported WI Michigan: 4,413 units · 44.0 per 100k residents MI New York: 85,223 units · 435 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,004 units · 71.6 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 1,292 units · 141 per 100k residents SD Iowa: 1,762 units · 54.9 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 19,269 units · 149 per 100k residents PA New Jersey: 8,850 units · 95.3 per 100k residents NJ Massachusetts: 259,424 units · 3,706 per 100k residents MA California: 12,770 units · 32.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 6,031 units · 305 per 100k residents NE Missouri: 3,500 units · 56.5 per 100k residents MO Kentucky: 4,531 units · 100 per 100k residents KY West Virginia: 828 units · 46.8 per 100k residents WV Virginia: 3,053 units · 35.0 per 100k residents VA Maryland: no data reported MD Connecticut: 8,454 units · 234 per 100k residents CT Rhode Island: 5,550 units · 507 per 100k residents RI Arizona: no data reported AZ New Mexico: 9,650 units · 456 per 100k residents NM Kansas: 5 units · 0.2 per 100k residents KS Arkansas: no data reported AR Tennessee: 16,886 units · 237 per 100k residents TN North Carolina: 5,605 units · 51.7 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 5,423 units · 119 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 13,215 units · 120 per 100k residents GA D.C.: no data reported DC Hawaii: 4,400 units · 307 per 100k residents HI Texas: 23,449 units · 76.9 per 100k residents TX Florida: 815 units · 3.6 per 100k residents FL
Units reimbursed · per 100k residents
0.23,706
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 Massachusetts 3,706 /100k
2 Montana 548 /100k
3 Rhode Island 507 /100k
4 New Mexico 456 /100k
5 New York 435 /100k
6 Hawaii 307 /100k
7 Nebraska 305 /100k
8 Tennessee 237 /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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1308 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00338-5003-41 · Baxter 00338-6010-48 · Baxter →
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.