Prescription medicine
Cefepime First approved as Maxipime
Cefepime (Maxipime) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 8 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the cefepime FDA label on DailyMed (effective November 15, 2021, Qilu Pharmaceutical Co., Ltd.); the NDA 50679 record on Drugs@FDA; every cefepime label on DailyMed.
Highlights of the record
FDA label of November 15, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCefepime for Injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms:
Pneumonia.
Forms and strengths
- 1 g
- 2 g
- 100 g
- 500 mg
- 1 g/50ml
- 1 g/20ml
- 2 g/50ml
- 2 g/20ml
Injection (powder) for solution; injection (solution).
On the market
- Earliest approval on file
- January 18, 1996 Maxipime, Hospira Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first June 18, 2007; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 8 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 10 since 2013 2 Class I among all firms' recalls; latest May 15, 2023; 4 more by firms not listed as its makers
- FAERS reports
- 16,018 through July 30, 2026
What is cefepime used for?
From the label: indications and usageCefepime for Injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms:
Pneumonia. ( 1.1 )
Empiric therapy for febrile neutropenic patients. ( 1.2 )
Uncomplicated and complicated urinary tract infections (including pyelonephritis). ( 1.3 )
Uncomplicated skin and skin structure infections. ( 1.4 )
Complicated intra-abdominal infections (used in combination with metronidazole) in adults. […]
Conditions named in the indications of cefepime's FDA labels, with every medicine labeled for each:
From other cefepime labelsUrinary tract infections: Infections (including pyelonephritis) Cefepime for Injection is indicated in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by susceptible isolates of Escherichia coli or …
FDA pharmacologic class: Cephalosporin Antibacterial.
Source: FDA drug label (Cefepime), Qilu Pharmaceutical Co., Ltd., effective November 15, 2021 (SPL set 80b4c811-4a71-47fb-8565-85ce9d0f782c), via openFDA; the full label on DailyMed
Is there a generic for cefepime (Maxipime)?
The FDA approved the first generic cefepime on June 18, 2007. 9 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cefepime from 8 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2007 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is cefepime in shortage?
No cefepime presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated February 10, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Cefepime Hydrochloride, Injection, 1 g (NDC 63323-326-20) | Fresenius Kabi USA, LLC | To Be Discontinued | February 10, 2026 |
| Cefepime Hydrochloride, Injection, 2 g (NDC 63323-340-20) | Fresenius Kabi USA, LLC | To Be Discontinued | February 10, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has cefepime been recalled?
The FDA's Enforcement Report lists 14 recalls naming cefepime since 2013: 2 Class I (the most serious), 12 Class II, 0 Class III; 0 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of cefepime and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 15, 2023 | Class II | Astral SteriTech Private Ltd. | Lack of Assurance of Sterility |
| December 27, 2022 | Class II | Sentara Infusion Services not a listed maker | Lack of sterility assurance |
| November 10, 2015 | Class II | Walgreens Infusion Services not a listed maker | Lack of Assurance of Sterility |
| September 18, 2015 | Class II | Sentara Enterprises | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. |
| May 28, 2015 | Class II | Lincare, Inc. not a listed maker | Lack of Assurance of Sterility: Sterility of product is not assured |
| May 28, 2015 | Class II | Lincare, Inc. not a listed maker | Lack of Assurance of Sterility: Sterility of product is not assured. |
| November 21, 2013 | Class I | B. Braun Medical Inc | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. |
| October 15, 2013 | Class I | B. Braun Medical Inc | Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cefepime label say about other medicines?
The cefepime label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Arginine | warnings and precautions | Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum recommended human dose of cefepime. |
| Furosemide | drug interactions | Diuretics: nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide. Monitor renal function. |
Source: FDA drug label (Cefepime), Qilu Pharmaceutical Co., Ltd., effective November 15, 2021 (SPL set 80b4c811-4a71-47fb-8565-85ce9d0f782c), via openFDA; the full label on DailyMed
What do FAERS reports show for cefepime?
The FDA Adverse Event Reporting System holds 16,018 reports that list cefepime among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,529 are coded as a death and 9,439 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cefepime?
13 other medicines are given the same way (intravenous) and in the same FDA class as cefepime or labeled mainly for the same use (urinary tract infections), the same class first. Urinary tract infections lists all 39 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cefazolin | Urinary tract infections | 7 labelers | $1.07 per vial 1 g vial | No current entry |
| Cefoxitin | Urinary tract infections | 5 labelers | n/a | No current entry |
| Ceftriaxone | Urinary tract infections | 7 labelers | $1.44 per vial 1 g vial | No current entry |
| Cefuroxime | Urinary tract infections | 2 labelers | n/a | No current entry |
| Avibactam and ceftazidime | Urinary tract infections | none listed | n/a | No current entry |
| Cefiderocol | Urinary tract infections | none listed | n/a | No current entry |
| Ceftolozane and tazobactam | Urinary tract infections | none listed | n/a | No current entry |
| Doxycycline | Urinary tract infections | 20 labelers | n/a | A presentation being discontinued |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does cefepime compare with medicines for the same use?
5 side-by-side pages set cefepime beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to cefepime
- 13 medicines for the same use
- Other cephalosporins
- the pharmacologic class, with prices and generics
- Cefepime side effects
- the label's list beside FAERS reports
- Cefepime shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other