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Cefepime 1 g/50mL Injection, Solution — NDC 0338-1301-48 (Billing 00338-1301-48)

by Baxter Healthcare Corporation · 12 BAG in 1 BOX / 100 mL in 1 BAG

This is a package of Cefepime 1 g/50mL Injection, Solution from Baxter Healthcare Corporation, marketed since Aug 2008 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00338-1301-48
🏷️ FDA NDC (as labeled) 0338-1301-48 billing pads the labeler segment with a zero
This package
Contains100 mL in 1 bag Medicaid pays$0.4045 / unit · 12 mo Per package$485.40 / 1200 ml · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $5.37/unit — full pricing hub ↓
Main listing for product 0338-1301 · Also comes in: 50 ml 0338-1301-41
Rx only Brand 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 0338-1301-48 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0338 labeler · 1301 product · 48 package
Package marketed since
Aug 5, 2008
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0338130148 4
Medicaid fills, this package
766 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0338-1301-48
Product NDC 0338-1301
11-digit billing NDC 00338130148
NCPDP billing unit ML — per mL (volume)
RxCUI 1665088, 1665093
UNII I8X1O0607P
Application # NDA050817
SPL Set ID be5f8ca6-7232-423a-a2d5-cccb7abe7921
Established class (EPC) Cephalosporin Antibacterial
Chemical class Cephalosporins
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-08-05
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance CEFEPIME HYDROCHLORIDE

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

GCN Seq No 064400
GCN 14236
HICL code 035848
Ingredient (HICL) Cefepime In Iso-Osm Dextrose
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1Z
Therapeutic class — specific (HIC3) Cephalosporin Antibiotics - 4Th Generation
AHFS code 08:12.06.16
AHFS class 4Th Generation Cephalosporin Antibiotics
FDB label name CEFEPIME 2 GM INJECTION
FDB brand name Cefepime
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 064400
  • GCN: 14236
  • HICL (First Databank): 035848
  • AHFS class code: 08:12.06.16
  • RxCUI (RxNorm): 1665088
Why two NDCs? The FDA registers this code as 0338-1301-48 — 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 → 00338-1301-48. 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 Cephalosporin Antibacterial class.

Pharmacologic class Cephalosporin Antibacterial
Drug family (ATC) Fourth-generation cephalosporins
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 CEFEPIME 2 GM INJECTION Ingredient Cefepime In Iso-Osm Dextrose
📗 Our plain-language guide HelloPharmacist
  • It treats bacterial infections such as pneumonia, urinary and kidney infections, skin infections and abdominal infections (with metronidazole). It is also used for fever when your...
  • A healthcare professional gives it, usually through a vein over about 30 minutes. For some mild to moderate urinary infections caused by E. coli, it can be given into a muscle. How...
  • Since your care team gives it, tell them if you think a dose was delayed or missed. They will decide how to get your schedule back on track. Please do not try to make up for it on...
  • What happens if I miss a dose of Cefepime Injection?
📖 Read our full Cefepime Injection guide →
7
Nutrient depletion considerations

Cefepime may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Cefepime 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 $0.4045 $485.40 / 1200 ml
Medicare drug plans payPart D · Q2 2026 $5.37 $6,442.92 / 1200 ml
Medicare Part B allowsASP · J0701 $6.027 / J0701 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)0338-1301-48
11-digit billing NDC00338-1301-48
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ0701
DescriptorInjection, cefepime hydrochloride (baxter), not therapeutically equivalent to maxipime, 500 mg
Billing units / pkg48 units
How the units are derivedThis package is 100; the HCPCS unit is 500 MG, so one package = 48 billing units.
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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
00338-1301-41 0338-1301-41 24 BAG in 1 BOX / 50 mL in 1 BAG 2008-08-05 — Active
00338-1301-48 You're viewing this Main listing 12 BAG in 1 BOX / 100 mL in 1 BAG 2008-08-05 — Active

In Medicaid, this is the most-dispensed pack of this product — about 86% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 12 bag in 1 box / 100 ml in 1 bag.
What NDC number is used to bill for this package of Cefepime 1 g/50mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cefepime 1 g/50mLthis 00338-1301-48 Baxter 100 ml — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2008
On the market since
Aug 2008
📍
2026
Currently FDA-listed
18 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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 Cefepime 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.

  • 1.03 g / 50 mL UNII 5SL0G7R0OK
    A simple sugar made from corn or other plants, used in medicines as a filler and sweetener. It helps create the right texture and taste in tablets, powders, and liquid formulations.
  • 725 mg / 50 mL UNII 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 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 applicationNDA050817 (NDA)
Labeler code00338
First marketedAug 2008
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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Cefepime Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: pneumonia ( 1.1 ); empiric therapy for febrile neutropenic patients ( 1.2 ); uncomplicated and complicated urinary tract infections ( 1.3 ); uncomplicated skin and skin structure infections ( 1.4 ); and complicated intra-abdominal infections (used in combination with metronidazole) ( 1.5 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime Injection and other antibacterial drugs, Cefepime Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.6 )

1.1Pneumonia Cefepime Injection is indicated for pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.

1.2Empiric Therapy for Febrile Neutropenic Patients Cefepime Injection as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients [ see Clinical Studies (14) ].

1.3Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis) Cefepime Injection is indicated for uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.

1.4Uncomplicated Skin and Skin Structure Infections Cefepime Injection is indicated for uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes .

1.5Complicated Intra-abdominal Infections Cefepime Injection is indicated for complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis [see Clinical Studies (14) ].

1.6Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime Injection and other antibacterial drugs, Cefepime Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Dosage in Adults With Creatinine Clearance (CrCL) Greater Than 60 mL/min ( 2.1 ) Site and Type of Infection (Adults) Dose (IV) Frequency Duration (Days) Moderate to Severe Pneumonia For Pseudomonas aeruginosa , use 2 g IV every 8 hours ( 2.1 ) 1-2 g Every 8-12 hours 10 Empiric therapy for febrile neutropenic patients 2 g Every 8 hours 7 Or until resolution of neutropenia ( 2.1 ) Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections 0.5-1 g Every 12 hours 7-10 Severe Uncomplicated or Complicated Urinary Tract Infections 2 g Every 12 hours 10 Moderate to Severe Uncomplicated Skin and Skin Structure Infections 2 g Every 12 hours 10 Complicated Intra-abdominal Infections (used in combination with metronidazole) 2 g Every 8-12 hours 7-10 • Pediatric Patients (2 months to 16 years) – Recommended dosage in pediatric with CrCL greater than 60 mL/min.

( 2.2 ) • The usual recommended dosage in pediatric patients is 50 mg per kg per dose administered every 12 hours (every 8 hours for febrile neutropenia). ( 2.2 ) • Cefepime Injection in Galaxy Container should be used only in pediatric patients who require the entire 1 gram or 2 gram dose and not any fraction thereof. ( 2.2 ) • Patients with Renal Impairment: Adjust dose in patients with CrCL less than or equal to 60 mL/min.

( 2.3 ) • Administer intravenously over approximately 30 minutes. ( 2.1 ) • Do not force thaw frozen container by immersion in water baths or by microwave irradiation. ( 2.4 )

2.1Dosage for Adults The recommended adult dosages and routes of administration are outlined in Table 1 below for patients with creatinine clearance greater than 60 mL/min. Administer Cefepime Injection intravenously over approximately 30 minutes. Table 1: Recommended Dosage Schedule for Cefepime Injection in Adult Patients with Creatinine Clearance (CrCL) Greater Than 60 mL/min Site and Type of Infection Dose Frequency Duration (days) Adults Moderate to Severe Pneumonia due to S. pneumoniae , P. aeruginosa For Pseudomonas aeruginosa , use 2 g IV every 8 hours , K. pneumoniae, or Enterobacter species 1-2 g IV Every 8-12 hours 10 Empiric therapy for febrile neutropenic patients [see Indications and Usage (1) and Clinical Studies (14) ] 2 g IV Every 8 hours 7 or until resolution of neutropenia.

In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re-evaluated frequently. Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis 0.5-1 g IV Every 12 hours 7-10 Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae 2 g IV Every 12 hours 10 Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes 2 g IV Every 12 hours 10 Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa , K. pneumoniae, Enterobacter species, or B. fragilis . [see Clinical Studies (14) ] 2 g IV Every 8-12 hours 7-10

2.2Pediatric Patients (2 months up to 16 years) The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for durations as given above for adults is: • 50 mg per kg per dose, administered every 12 hours for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia (see below). • For moderate to severe pneumonia due to P. aeruginosa give 50 mg per kg per dose, every 8 hours. • 50 mg per kg per dose, every 8 hours for febrile neutropenic patients.

Cefepime Injection in Galaxy Container should be used only in pediatric patients who require the entire 1 or 2 g dose and not any fraction thereof.

2.3Dosage Adjustments i… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 69 words ▾

3 DOSAGE FORMS AND STRENGTHS Cefepime Injection is available in the following strengths: • 1 g in 50 mL (contains 1 g of cefepime as Cefepime Hydrochloride, USP) single-dose Galaxy Container • 2 g in 100 mL (contains 2 g of cefepime as Cefepime Hydrochloride, USP) single-dose Galaxy Container • Cefepime Injection: 1 g in 50 mL and 2 g in 100 mL single-dose Galaxy Container. ( 3 )

⛔ Contraindications 67 words ▾

4 CONTRAINDICATIONS Cefepime Injection is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibacterials, penicillins or other beta-lactam antibacterial drugs. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products. • Prior immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibacterial drugs, penicillins, and other beta-lactam antibacterial drugs. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefepime Injection occurs, discontinue the drug. ( 5.1 ) • Neurotoxicity: May occur especially in patients with renal impairment administered unadjusted doses.

If neurotoxicity associated with Cefepime Injection therapy occurs, discontinue the drug. ( 5.2 ) • Clostridioides difficile Associated Diarrhea (CDAD): Evaluate if diarrhea occurs. ( 5.3 )

5.1Hypersensitivity Reactions Before therapy with Cefepime Injection is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefepime, cephalosporins, penicillins, or other beta-lactams. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibacterial drugs has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy.

If an allergic reaction to Cefepime Injection occurs, discontinue the drug and institute appropriate supportive measures.

5.2Neurotoxicity Serious adverse reactions have been reported including life-threatening or fatal occurrences of the following: encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), aphasia, myoclonus, seizures, and nonconvulsive status epilepticus [see Adverse Reactions (6.2) ]. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment. However, some cases of neurotoxicity occurred in patients receiving a dosage adjustment appropriate for their degree of renal impairment.

In the majority of cases, symptoms of neurotoxicity were reversible and resolved after discontinuation of cefepime and/or after hemodialysis. If neurotoxicity associated with cefepime therapy occurs, discontinue cefepime and institute appropriate supportive measures.

5.3Clostridioides difficile Associated Diarrhea Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefepime Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

5.4Development of Drug-Resistant Bacteria Prescribing cefepime in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. As with other antimicrobials, prolonged use of cefepime may result in overgrowth of nonsusceptible microorganisms. Repeated evaluation of the patient’s condition is essential.

Should superinfection occur during therapy, appropriate measures should be taken.

5.5Drug/Laboratory Test Interactions Urinary Glucose The administration of cefepime may result in a false-positive reaction for glucose in the urine when using some methods (e.g. Clinitest tablets) [see Drug Interactions (7.1)] . Coombs' Tests Positive direct Coombs’ tests have been re… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Hypersensitivity reactions [see Warnings and Precautions (5.1) ] • Neurotoxicity [see Warnings and Precautions (5.2) ] • Clostridioides difficile -associated diarrhea [see Warnings and Precautions (5.3) ] • The most common adverse reactions (incidence ≥ 1 %) were local reactions positive Coombs’ test, decreased phosphorous, increased ALT and AST, increased PT and PTT and rash. ( 6.1 ) • At the highest dose (2 g every 8 hours), incidence of adverse reactions was ≥1% for rash, diarrhea, nausea, vomiting, pruritis, fever, and headache.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter at 1-866-888-2472 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. In clinical trials using multiple doses of cefepime, 4137 patients were treated with the recommended dosages of cefepime (500 mg to 2 g intravenously every 12 hours). There were no deaths or permanent disabilities thought related to drug toxicity.

Sixty‑four (1.5%) patients discontinued medication due to adverse reactions. Thirty-three (51%) of these 64 patients who discontinued therapy did so because of rash. The percentage of cefepime-treated patients who discontinued study drug because of drug-related adverse reactions was similar at daily doses of 500 mg, 1 g, and 2 g every 12 hours (0.8%, 1.1%, and 2%, respectively).

However, the incidence of discontinuation due to rash increased with the higher recommended doses. The following adverse reactions ( Table 3 ) were identified in clinical trials conducted in North America (n=3125 cefepime-treated patients). Table 3: Adverse Reactions in Cefepime Multiple-Dose Dosing Regimens Clinical Trials in North America INCIDENCE EQUAL TO OR GREATER THAN 1% Local adverse reactions (3%), including phlebitis (1.3%), pain and/or inflammation (0.6%) Local reactions, irrespective of relationship to cefepime in those patients who received intravenous infusion (n=3048). ; rash (1.1%) INCIDENCE LESS THAN 1% BUT GREATER THAN 0.1% Colitis (including pseudomembranous colitis), diarrhea, erythema, fever, headache, nausea, oral moniliasis, pruritus, urticaria, vaginitis, vomiting, anemia At the higher dose of 2 g every 8 hours, the incidence of adverse reactions was higher among the 795 patients who received this dose of cefepime.

They consisted of rash (4%), diarrhea (3%), nausea (2%), vomiting (1%), pruritus (1%), fever (1%), and headache (1%). The following ( Table 4 ) adverse laboratory changes with cefepime, were seen during clinical trials conducted in North America. Table 4: Adverse Laboratory Changes in Cefepime Multiple-Dose Dosing Regimens Clinical Trials in North America INCIDENCE EQUAL TO OR GREATER THAN 1% Positive Coombs’ test (without hemolysis) (16.2%); decreased phosphorus (2.8%); increased Alanine Transaminase (ALT) (2.8%), Aspartate Transaminase (AST) (2.4%), eosinophils (1.7%); abnormal PTT (1.6%), Prothrombin Time (PT) (1.4%) INCIDENCE LESS THAN 1% BUT GREATER THAN 0.1% Increased alkaline phosphatase, Blood Urea Nitrogen (BUN), calcium, creatinine, phosphorus, potassium, total bilirubin; decreased calcium Hypocalcemia was more common among elderly patients.

Clinical consequences from changes in either calcium or phosphorus were not reported. , hematocrit, neutrophils, platelets, White Blood Cells (WBC) A similar safety profile was seen in clinical trials of pediatric patients.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of Cefepime Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 130 words ▾

7 DRUG INTERACTIONS • Aminoglycosides -- increased potential of nephrotoxicity and ototoxicity. ( 7.2 ) • Diuretics -- nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide. ( 7.3 )

7.1Drug/Laboratory Test Interactions The administration of cefepime may result in a false-positive reaction for glucose in the urine with certain methods. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used [see Warning and Precautions (5.5)] .

7.2Aminoglycosides Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime Injection because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs.

7.3Diuretics Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

🔄 Drug / Laboratory Test Interactions 173 words ▾

5.5Drug/Laboratory Test Interactions Urinary Glucose The administration of cefepime may result in a false-positive reaction for glucose in the urine when using some methods (e.g. Clinitest tablets) [see Drug Interactions (7.1)] . Coombs' Tests Positive direct Coombs’ tests have been reported during treatment with cefepime.

In patients who develop hemolytic anemia, discontinue the drug and institute appropriate therapy. Positive Coombs’ test may be observed in newborns whose mothers have received cephalosporin antibacterials before parturition. Prothrombin Time Many cephalosporins, including cefepime, have been associated with a fall in prothrombin activity.

Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antibacterial therapy. Prothrombin time should be monitored in patients at risk, and exogenous vitamin K administered as indicated.

7.1Drug/Laboratory Test Interactions The administration of cefepime may result in a false-positive reaction for glucose in the urine with certain methods. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used [see Warning and Precautions (5.5)] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Geriatric Use – Serious adverse reactions have occurred in geriatric patients with renal impairment given unadjusted doses of cefepime. ( 8.5 )

8.1Pregnancy Risk summary There are no cases of cefepime exposure during pregnancy reported from postmarketing experience or from clinical trials. Available data from published observational studies and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ). Cefepime was not associated with adverse developmental outcomes in rats, mice, or rabbits when administered parenterally during the period of organogenesis.

The doses used in these studies were 1.6 times (rats), approximately equal to (mice) and 0.3 times (rabbits) the maximum recommended clinical dose ( see Data) . The estimated background risk of 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 estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data While available studies cannot definitively establish the absence of risk, published data from case-control studies and case reports over several decades have not identified an association with cephalosporin use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups.

Animal data Cefepime was not embryocidal and did not cause fetal malformations when administered parenterally during the period of organogenesis to rats at doses up to 1000 mg/kg/day, to mice at doses up to 1200 mg/kg/day, or to rabbits at doses up to 100 mg/kg/day. These doses are 1.6 times (rats), approximately equal to (mice), and 0.3 times (rabbits) the maximum recommended clinical dose based on body surface area.

8.2Lactation Risk Summary Cefepime is present in human milk at low concentration (0.5 mcg/mL). A nursing infant consuming approximately 1000 mL of human milk per day would receive approximately 0.5 mg of cefepime per day. There is no information regarding effects of cefepime on milk production or on the breastfed infant.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cefepime and any potential adverse effects on the breastfed child from cefepime or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of cefepime in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, pneumonia, and as empiric therapy for febrile neutropenic patients have been established in the age groups 2 months up to 16 years. Use of Cefepime Injection in these age groups is supported by evidence from adequate and well-controlled studies of cefepime in adults with additional pharmacokinetic and safety data from pediatric trials [see Clinical Pharmacology (12) ].

Safety and effectiveness in pediatric patients below the age of 2 months have not been established. There are insufficient clinical data to support the use of Cefepime Injection in pediatric patients under 2 months of age or for the treatment of serious infections in the pediatric population where the suspected or proven pathogen is Haemophilus influenzae type b. In those patients in whom meningeal seeding from a distant infection site or in whom meningitis is suspected or documented, an alternate agent with demonstrated clinical efficacy in this setting should be used.

Cefepime Injection in Galaxy Container should be used only in pediatric patients who require the entire 1… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk summary There are no cases of cefepime exposure during pregnancy reported from postmarketing experience or from clinical trials. Available data from published observational studies and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ). Cefepime was not associated with adverse developmental outcomes in rats, mice, or rabbits when administered parenterally during the period of organogenesis.

The doses used in these studies were 1.6 times (rats), approximately equal to (mice) and 0.3 times (rabbits) the maximum recommended clinical dose ( see Data) . The estimated background risk of 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 estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data While available studies cannot definitively establish the absence of risk, published data from case-control studies and case reports over several decades have not identified an association with cephalosporin use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups.

Animal data Cefepime was not embryocidal and did not cause fetal malformations when administered parenterally during the period of organogenesis to rats at doses up to 1000 mg/kg/day, to mice at doses up to 1200 mg/kg/day, or to rabbits at doses up to 100 mg/kg/day. These doses are 1.6 times (rats), approximately equal to (mice), and 0.3 times (rabbits) the maximum recommended clinical dose based on body surface area.

🧒 Pediatric Use 201 words ▾

8.4Pediatric Use The safety and effectiveness of cefepime in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, pneumonia, and as empiric therapy for febrile neutropenic patients have been established in the age groups 2 months up to 16 years. Use of Cefepime Injection in these age groups is supported by evidence from adequate and well-controlled studies of cefepime in adults with additional pharmacokinetic and safety data from pediatric trials [see Clinical Pharmacology (12) ].

Safety and effectiveness in pediatric patients below the age of 2 months have not been established. There are insufficient clinical data to support the use of Cefepime Injection in pediatric patients under 2 months of age or for the treatment of serious infections in the pediatric population where the suspected or proven pathogen is Haemophilus influenzae type b. In those patients in whom meningeal seeding from a distant infection site or in whom meningitis is suspected or documented, an alternate agent with demonstrated clinical efficacy in this setting should be used.

Cefepime Injection in Galaxy Container should be used only in pediatric patients who require the entire 1 or 2 g dose and not any fraction thereof.

🧓 Geriatric Use 159 words ▾

8.5Geriatric Use Of the more than 6400 adults treated with cefepime in clinical studies, 35% were 65 years or older while 16% were 75 years or older. When geriatric patients received the usual recommended adult dose, clinical efficacy and safety were comparable to clinical efficacy and safety in nongeriatric adult patients. Serious adverse events have occurred in geriatric patients with renal impairment given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures [see Warnings and Precautions (5) and Adverse Reactions (6) ].

This drug 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, care should be taken in dose selection, and renal function should be monitored [see Clinical Pharmacology (12) , Warnings and Precautions (5) , and Dosage and Administration (2) ].

🆘 Overdosage 87 words ▾

10 OVERDOSAGE Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal impairment, hemodialysis, not peritoneal dialysis, is recommended to aid in the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function.

Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability [see Warnings and Precautions (5) , Adverse Reactions (6) , and Dosage and Administration (2) ].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Cefepime is an antibacterial drug. [See Microbiology (12.4) ]

12.2Pharmacodynamics Similar to other beta-lactam antibacterial drugs, the time that the unbound plasma concentration of cefepime exceeds the MIC of the infecting organism has been shown to best correlate with efficacy in animal models of infection. However, the pharmacokinetic/pharmacodynamic relationship for cefepime has not been evaluated in patients.

12.3Pharmacokinetics Pharmacokinetic parameters for cefepime in healthy adult male volunteers (n=9) following single 30-minute intravenous infusions of cefepime 500 mg, 1 g, and 2 g are summarized in Table 6 . Elimination of cefepime is principally via renal excretion with an average (±SD) half-life of 2 (±0.3) hours and total body clearance of 120 (±8) mL/min in healthy volunteers. Cefepime pharmacokinetics are linear over the range 250 mg to 2 g.

There is no evidence of accumulation in healthy adult male volunteers (n=7) receiving clinically relevant doses for a period of 9 days. Table 6: Mean Pharmacokinetic Parameters for Cefepime (±SD), Intravenous Administration CEFEPIME Parameter 500 mg IV 1 g IV 2 g IV C max , mcg/mL 39.1 (3.5) 81.7 (5.1) 163.9 (25.3) AUC, h•mcg/mL 70.8 (6.7) 148.5 (15.1) 284.8 (30.6) Number of subjects (male) 9 9 9 Distribution The average steady-state volume of distribution of cefepime is 18.0 (±2.0) L. The serum protein binding of cefepime is approximately 20% and is independent of its concentration in serum.

Concentrations of cefepime achieved in specific tissues and body fluids are listed in Table 7 . Table 7: Mean Concentrations of Cefepime in Specific Body Fluids (mcg/mL) or Tissues (mcg/g) Tissue or Fluid Dose/Route # of Patients Mean Time of Sample Post-Dose (h) Mean Concentration Blister Fluid 2 g IV 6 1.5 81.4 mcg/mL Bronchial Mucosa 2 g IV 20 4.8 24.1 mcg/g Sputum 2 g IV 5 4 7.4 mcg/mL Urine 500 mg IV 8 0-4 292 mcg/mL 1 g IV 12 0-4 926 mcg/mL 2 g IV 12 0-4 3120 mcg/mL Bile 2 g IV 26 9.4 17.8 mcg/mL Peritoneal Fluid 2 g IV 19 4.4 18.3 mcg/mL Appendix 2 g IV 31 5.7 5.2 mcg/g Gall Bladder 2 g IV 38 8.9 11.9 mcg/g Prostate 2 g IV 5 1 31.5 mcg/g Data suggest that cefepime does cross the inflamed blood-brain barrier.

The clinical relevance of these data is uncertain at this time. Metabolism and Excretion Cefepime is metabolized to N-methylpyrrolidine (NMP), which is rapidly converted to the N-oxide (NMP-N-oxide). Urinary recovery of unchanged cefepime accounts for approximately 85% of the administered dose.

Less than 1% of the administered dose is recovered from urine as NMP, 6.8% as NMP-N-oxide, and 2.5% as an epimer of cefepime. Because renal excretion is a significant pathway of elimination, patients with renal dysfunction and patients undergoing hemodialysis require dosage adjustment [see Dosage and Administration (2) ]. Specific Populations Patients with Renal Impairment Cefepime pharmacokinetics have been investigated in patients with various degrees of renal impairment (n=30).

The average half-life in patients requiring hemodialysis was 13.5 (±2.7) hours and in patients requiring continuous peritoneal dialysis was 19 (±2.0) hours. Cefepime total body clearance decreased proportionally with creatinine clearance in patients with abnormal renal function, which serves as the basis for dosage adjustment recommendations in this group of patients [see Dosage and Administration (2) ]. Patients with Hepatic Impairment The pharmacokinetics of cefepime were unaltered in patients with hepatic impairment who received a single 1 g dose (n=11).

Geriatric Patients Cefepime pharmacokinetics have been investigated in elderly (65 years of age and older) men (n=12) and women (n=12) whose mean (SD) creatinine clearance was 74.0 (±15.0) mL/min. There appeared to be a decrease in cefepime total body clearance as a function of creatinine clearance. Therefore, dosage administration of cefepime in the elderly should be adjusted as appropriate if the pat… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 13 words ▾

12.1Mechanism of Action Cefepime is an antibacterial drug. [See Microbiology (12.4) ]

📦 How Supplied / Storage and Handling 125 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Cefepime Injection is supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in 50 mL and 100 mL single-dose Galaxy Containers as follows: 1 g Based on cefepime activity in 50 mL Supplied 24/box NDC 0338-1301-41 2 g in 100 mL Supplied 12/box NDC 0338-1301-48 Store at or below –20°C (-4°F). Handle frozen product containers with care. Product containers may be fragile in the frozen state.

Thaw frozen container at room temperature 25°C (77°F) or under refrigeration 5°C (41°F). Do not force thaw by immersion in water baths or by microwave irradiation. The thawed solution remains stable for 7 days under refrigeration 5°C (41°F) or 24 hours at room temperature 25°C (77°F).

Do not refreeze. [See Dosage and Administration (2.4) ].

📋 Description ~2 min read ▾

11 DESCRIPTION Cefepime Injection in Galaxy Container is a sterile, injectable product consisting of Cefepime Hydrochloride, USP, a semi-synthetic, broad spectrum, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride (monohydrate) has a molecular mass of 571.50 and a molecular formula of C 19 H 25 ClN 6 O 5 S 2 •HCl•H 2 O.

Cefepime Injection in Galaxy Container is a frozen, iso-osmotic, sterile, non-pyrogenic premixed solution supplied for intravenous administration in strengths equivalent to 1 g and 2 g of cefepime [see Dosage and Administration (2) ]. It contains the equivalent of not less than 90 percent and not more than 115 percent of the labeled amount of cefepime (C 19 H 24 N 6 O 5 S 2 ). The solution is intended for intravenous use after thawing to room temperature.

The components and dosage formulations are given in the table below: Table 5: Cefepime Injection in Galaxy Containers Premixed Frozen Solution Component Cefepime is present in the formulation as Cefepime Hydrochloride, USP. The amounts of Dextrose Hydrous, USP and L-Arginine, USP are approximate. Function Dosage Formulations 1 g in 50 mL 2 g in 100 mL Cefepime active ingredient 1 g 2 g Dextrose Hydrous, USP osmolality adjuster 1.03 g 2.06 g L-Arginine, USP The pH may have been adjusted with hydrochloric acid and/or additional L-Arginine, USP.

The pH is 4.0 – 6.0. pH adjuster 725 mg 1.45 g Hydrochloric Acid pH adjuster As needed As needed Water for Injection, USP vehicle q.s. This is an abbreviation for sufficient quantity. 50 mL q.s.

100 mL Cefepime Injection will range in color from colorless to amber. The plastic container is fabricated from a specially designed multilayer plastic. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period.

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

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Antibacterial Resistance Patients should be counseled that antibacterial drugs including Cefepime Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefepime Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefepime Injection or other antibacterial drugs in the future. Diarrhea Diarrhea is a common problem caused by antibacterial drugs, which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug.

If this occurs, patients should be instructed to contact their physician as soon as possible. Neurotoxicity Advise patients of neurological adverse events that could occur with Cefepime Injection use. Instruct patients or their caregivers to inform their healthcare provider at once of any neurological signs and symptoms, including encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), aphasia (disturbance of speaking and understanding spoken and written language), myoclonus, seizures and nonconvulsive status epilepticus, for immediate treatment, dosage adjustment, or discontinuation of Cefepime Injection.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Pharmacokinetic parameters for cefepime in healthy adult male volunteers (n=9) following single 30-minute intravenous infusions of cefepime 500 mg, 1 g, and 2 g are summarized in Table 6 . Elimination of cefepime is principally via renal excretion with an average (±SD) half-life of 2 (±0.3) hours and total body clearance of 120 (±8) mL/min in healthy volunteers. Cefepime pharmacokinetics are linear over the range 250 mg to 2 g.

There is no evidence of accumulation in healthy adult male volunteers (n=7) receiving clinically relevant doses for a period of 9 days. Table 6: Mean Pharmacokinetic Parameters for Cefepime (±SD), Intravenous Administration CEFEPIME Parameter 500 mg IV 1 g IV 2 g IV C max , mcg/mL 39.1 (3.5) 81.7 (5.1) 163.9 (25.3) AUC, h•mcg/mL 70.8 (6.7) 148.5 (15.1) 284.8 (30.6) Number of subjects (male) 9 9 9 Distribution The average steady-state volume of distribution of cefepime is 18.0 (±2.0) L. The serum protein binding of cefepime is approximately 20% and is independent of its concentration in serum.

Concentrations of cefepime achieved in specific tissues and body fluids are listed in Table 7 . Table 7: Mean Concentrations of Cefepime in Specific Body Fluids (mcg/mL) or Tissues (mcg/g) Tissue or Fluid Dose/Route # of Patients Mean Time of Sample Post-Dose (h) Mean Concentration Blister Fluid 2 g IV 6 1.5 81.4 mcg/mL Bronchial Mucosa 2 g IV 20 4.8 24.1 mcg/g Sputum 2 g IV 5 4 7.4 mcg/mL Urine 500 mg IV 8 0-4 292 mcg/mL 1 g IV 12 0-4 926 mcg/mL 2 g IV 12 0-4 3120 mcg/mL Bile 2 g IV 26 9.4 17.8 mcg/mL Peritoneal Fluid 2 g IV 19 4.4 18.3 mcg/mL Appendix 2 g IV 31 5.7 5.2 mcg/g Gall Bladder 2 g IV 38 8.9 11.9 mcg/g Prostate 2 g IV 5 1 31.5 mcg/g Data suggest that cefepime does cross the inflamed blood-brain barrier.

The clinical relevance of these data is uncertain at this time. Metabolism and Excretion Cefepime is metabolized to N-methylpyrrolidine (NMP), which is rapidly converted to the N-oxide (NMP-N-oxide). Urinary recovery of unchanged cefepime accounts for approximately 85% of the administered dose.

Less than 1% of the administered dose is recovered from urine as NMP, 6.8% as NMP-N-oxide, and 2.5% as an epimer of cefepime. Because renal excretion is a significant pathway of elimination, patients with renal dysfunction and patients undergoing hemodialysis require dosage adjustment [see Dosage and Administration (2) ]. Specific Populations Patients with Renal Impairment Cefepime pharmacokinetics have been investigated in patients with various degrees of renal impairment (n=30).

The average half-life in patients requiring hemodialysis was 13.5 (±2.7) hours and in patients requiring continuous peritoneal dialysis was 19 (±2.0) hours. Cefepime total body clearance decreased proportionally with creatinine clearance in patients with abnormal renal function, which serves as the basis for dosage adjustment recommendations in this group of patients [see Dosage and Administration (2) ]. Patients with Hepatic Impairment The pharmacokinetics of cefepime were unaltered in patients with hepatic impairment who received a single 1 g dose (n=11).

Geriatric Patients Cefepime pharmacokinetics have been investigated in elderly (65 years of age and older) men (n=12) and women (n=12) whose mean (SD) creatinine clearance was 74.0 (±15.0) mL/min. There appeared to be a decrease in cefepime total body clearance as a function of creatinine clearance. Therefore, dosage administration of cefepime in the elderly should be adjusted as appropriate if the patient’s creatinine clearance is 60 mL/min or less [see Dosage and Administration (2) ].

Pediatric Patients Cefepime pharmacokinetics have been evaluated in pediatric patients from 2 months to 11 years of age following single and multiple doses on every 8 hours (n=29) and every 12 hours (n=13) schedules. Following a single intravenous dose, total body clearance and the steady-state volume of distribution averaged 3.3 (±1.0) mL/min/kg and 0.3 (±0.1) L/kg, respectively.… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 49 words ▾

12.2Pharmacodynamics Similar to other beta-lactam antibacterial drugs, the time that the unbound plasma concentration of cefepime exceeds the MIC of the infecting organism has been shown to best correlate with efficacy in animal models of infection. However, the pharmacokinetic/pharmacodynamic relationship for cefepime has not been evaluated in patients.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

14.1Febrile Neutropenic Patients The safety and efficacy of empiric cefepime monotherapy of febrile neutropenic patients have been assessed in two multicenter, randomized trials, comparing cefepime monotherapy (at a dose of 2 g intravenously every 8 hours) to ceftazidime monotherapy (at a dose of 2 g intravenously every 8 hours). These studies comprised 317 evaluable patients. Table 8 describes the characteristics of the evaluable patient population.

Table 8: Demographics of Evaluable Patients (First Episodes Only) Cefepime Ceftazidime Total 164 153 Median age (yr) 56 (range, 18-82) 55 (range, 16-84) Male 86 (52%) 85 (56%) Female 78 (48%) 68 (44%) Leukemia 65 (40%) 52 (34%) Other hematologic malignancies 43 (26%) 36 (24%) Solid tumor 54 (33%) 56 (37%) Median ANC nadir (cells per microliter) 20 (range, 0-500) 20 (range, 0-500) Median duration of neutropenia (days) 6 (range, 0-39) 6 (range, 0-32) Indwelling venous catheter 97 (59%) 86 (56%) Prophylactic antibiotics 62 (38%) 64 (42%) Bone marrow graft 9 (5%) 7 (5%) SBP less than 90 mm Hg at entry 7 (4%) 2 (1%) ANC = absolute neutrophil count; SBP = systolic blood pressure Table 9 describes the clinical response rates observed.

For all outcome measures, cefepime was therapeutically equivalent to ceftazidime. Table 9: Pooled Response Rates for Empiric Therapy of Febrile Neutropenic Patients % Response Cefepime Ceftazidime Outcome Measures (n = 164) (n = 153) Primary episode resolved with no treatment modification, no new febrile episodes or infection, and oral antibiotics allowed for completion of treatment 51 55 Primary episode resolved with no treatment modification, no new febrile episodes or infection, and no post-treatment oral antibiotics 34 39 Survival, any treatment modification allowed 93 97 Primary episode resolved with no treatment modification and oral antibiotics allowed for completion of treatment 62 67 Primary episode resolved with no treatment modification and no post-treatment oral antibiotics 46 51 Insufficient data exist to support the efficacy of cefepime monotherapy in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia).

No data are available in patients with septic shock.

14.2Complicated Intra-abdominal Infections Patients hospitalized with complicated intra-abdominal infections participated in a randomized, double-blind, multicenter trial comparing the combination of cefepime (2 g every 12 hours) plus intravenous metronidazole (500 mg every 6 hours) versus imipenem/cilastatin (500 mg every 6 hours) for a maximum duration of 14 days of therapy. The study was designed to demonstrate equivalence of the two therapies. The primary analyses were conducted on the protocol-valid population, which consisted of those with a surgically confirmed complicated infection, at least one pathogen isolated pretreatment, at least 5 days of treatment, and a 4 to 6 week follow-up assessment for cured patients.

Subjects in the imipenem/cilastatin arm had higher APACHE II scores at baseline. The treatment groups were otherwise generally comparable with regard to their pretreatment characteristics. The overall clinical cure rate among the protocol-valid patients was 81% (51 cured/63 evaluable patients) in the cefepime plus metronidazole group and 66% (62/94) in the imipenem/cilastatin group.

The observed differences in efficacy may have been due to a greater proportion of patients with high APACHE II scores in the imipenem/cilastatin group.

🧪 Nonclinical Toxicology 118 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No animal carcinogenicity studies have been conducted with cefepime. In chromosomal aberration studies, cefepime was positive for clastogenicity in primary human lymphocytes, but negative in Chinese hamster ovary cells. In other in vitro assays (bacterial and mammalian cell mutation, DNA repair in primary rat hepatocytes, and sister chromatid exchange in human lymphocytes), cefepime was negative for genotoxic effects.

Moreover, in vivo assessments of cefepime in mice (2 chromosomal aberration and 2 micronucleus studies) were negative for clastogenicity. No untoward effects on fertility were observed in rats when cefepime was administered subcutaneously at doses up to 1000 mg/kg/day (1.6 times the recommended maximum human dose based on body surface area).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 115 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No animal carcinogenicity studies have been conducted with cefepime. In chromosomal aberration studies, cefepime was positive for clastogenicity in primary human lymphocytes, but negative in Chinese hamster ovary cells. In other in vitro assays (bacterial and mammalian cell mutation, DNA repair in primary rat hepatocytes, and sister chromatid exchange in human lymphocytes), cefepime was negative for genotoxic effects.

Moreover, in vivo assessments of cefepime in mice (2 chromosomal aberration and 2 micronucleus studies) were negative for clastogenicity. No untoward effects on fertility were observed in rats when cefepime was administered subcutaneously at doses up to 1000 mg/kg/day (1.6 times the recommended maximum human dose based on body surface area).

📚 References 17 words ▾

15 REFERENCES 1. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976; 16:31-41.

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

PACKAGE LABEL - PRINCIPLE DISPLAY PANEL Container Label Baxter 1 g Cefepime Injection GALAXY Single-Dose Container 50 mL Iso-osmotic NDC 0338-1301-41 Code 2G3578 Each 50 mL contains: Cefepime Hydrochloride, USP equivalent to 1 g of cefepime with approx. 1.03 g of Dextrose Hydrous, USP added to adjust osmolality. Approx.

725 mg of L-Arginine, USP added per g of cefepime to adjust the pH. The pH may have been adjusted with hydrochloric acid and/or additional L-Arginine, USP. The pH is 4.0 - 6.0.

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

Must not be used in series connections. Check for minute leaks and solution clarity. Store at or below -20°C/-4°F.

Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. Thawed solution remains stable for 7 days under refrigeration (5°C/41°F) or 24 hours at room temperature (25°C/77°F).

Do not refreeze. Rx Only Baxter and GALAXY are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation Deerfield, IL 60015 USA PL 2040 Plastic Made in USA 07-34-63-744 Carton Label_panel 1 of 3 Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F).

DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. Thawed solution remains stable for 7 days under refrigeration (5°C/41°F) or 24 hours at room temperature (25°C/77°F). Do not refreeze.

Handle frozen product containers with care. Product containers may be fragile in the frozen state. Baxter and Galaxy are registered trademarks of Baxter International Inc.

Baxter Healthcare Corporation , Deerfield, IL 60015 USA 07-04-65-195 Made in USA PL 2040 Plastic Baxter Logo 1 g Cefepime Injection Rx Only Carton Label_panel 2 of 3 12 - 50 mL Single-Dose Containers. Iso-osmotic. NDC 0338-1301-41 Store at or below -20°C/-4°F.

Do not refreeze. Code 2G3578 *BAR CODE POSITION ONLY (01) 20303381301419 Carton Label_panel 3 of 3 GALAXY Container Sterile Nonpyrogenic Each 50 mL contains: Cefepime Hydrochloride, USP equivalent to 1 g of cefepime with approx. 1.03 g of Dextrose Hydrous, USP added to adjust osmolality.

Approx. 725 mg of L-Arginine, USP added per g of cefepime to adjust the pH. The pH may have been adjusted with hydrochloric acid and/or additional L-Arginine, USP.

The pH is 4.0 - 6.0. Dosage: Intravenously as directed by a physician. See insert.

Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks and solution clarity.

Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.

Representative Cefepime Container Label Representative Cefepime Carton Label_panel 1 of 3 Representative Cefepime Carton Label_panel 2 of 3 Representative Cefepime Carton Label_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
766
Units reimbursed last 4 qtrs
413.7K
Gross reimbursed last 4 qtrs
$167.4K
Avg / prescription
$218.47
Avg / unit
$0.4045
Latest quarter Q1 2026
164Rx
Fee-for-service vs managed care ⓘ
47% FFS 53% MCO
Fee-for-service · 359 Rx Managed care · 407 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 8,200 units · 143 per 100k residents MN Wisconsin: 23,800 units · 403 per 100k residents WI Michigan: 9,500 units · 94.6 per 100k residents MI New York: 18,300 units · 93.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 26,800 units · 839 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 7,900 units · 246 per 100k residents IA Illinois: no data reported IL Indiana: 10,300 units · 150 per 100k residents IN Ohio: 54,105 units · 459 per 100k residents OH Pennsylvania: 2,600 units · 20.1 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 7,921 units · 113 per 100k residents MA California: 31,902 units · 81.9 per 100k residents CA Utah: 11,000 units · 322 per 100k residents UT Colorado: no data reported CO Nebraska: 1,750 units · 88.5 per 100k residents NE Missouri: no data reported MO Kentucky: 25,360 units · 560 per 100k residents KY West Virginia: 124,500 units · 7,034 per 100k residents WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 11,700 units · 323 per 100k residents CT Rhode Island: no data reported RI Arizona: 15,600 units · 210 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: 6,600 units · 640 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 15,900 units · 144 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
20.17,034
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 West Virginia 7,034 /100k
2 Nevada 839 /100k
3 Delaware 640 /100k
4 Kentucky 560 /100k
5 Ohio 459 /100k
6 Wisconsin 403 /100k
7 Connecticut 323 /100k
8 Utah 322 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 ml this page00338-1301-48 766 Rx · $167,351
50 ml00338-1301-41 125 Rx · $15,459
Drug total (last 4 qtrs): 891 Rx · 440,438 units · $182,810 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cefepime — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Cefepime. 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
$154.2K
Claims incl. refills
565
Beneficiaries
208
Spend / beneficiary
$741.33
Spend / claim
$272.91
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 — Not published for this NDC No photo available yet for this listing.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 50 ml (00338-1301-41). Each has its own NDC and its own page — see the package list near the top of this page.
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 J0701 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.
← 00338-1148-03 · Baxter 00338-1305-01 · 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.