Prescription medicine
Cilastatin and imipenem and relebactam Brand names: Recarbrio
Cilastatin and imipenem and relebactam (Recarbrio) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
- A presentation discontinued
Check it at the source: the cilastatin and imipenem and relebactam FDA label on DailyMed (effective December 9, 2025, Merck Sharp & Dohme LLC); the NDA 212819 record on Drugs@FDA; every cilastatin and imipenem and relebactam label on DailyMed.
Highlights of the record
FDA label of December 9, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor, indicated in adult and pediatric patients weighing at least 2 kg for the treatment of the following infections caused by susceptible gram-negative microorganisms: Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Forms and strengths
- 500 mg/100ml / 500 mg/100ml / 250 mg/100ml
Injection (powder) for solution.
On the market
- Earliest approval on file
- July 16, 2019 Recarbrio, Msd Merck Co; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 21, 2033 Recarbrio injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 92 through July 30, 2026
What is cilastatin and imipenem and relebactam used for?
From the label: indications and usageRECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor, indicated in adult and pediatric patients weighing at least 2 kg for the treatment of the following infections caused by susceptible gram-negative microorganisms: Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). ( 1.1 ) Complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options. ( 1.2 ) Complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options. […]
Conditions named in the indications of cilastatin and imipenem and relebactam's FDA labels, with every medicine labeled for each:
From other cilastatin and imipenem and relebactam labelsUrinary tract infections: … have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible gram-negative microorganisms:
FDA pharmacologic class: Penem Antibacterial, Renal Dehydropeptidase Inhibitor and beta Lactamase Inhibitor.
Source: FDA drug label (RECARBRIO), Merck Sharp & Dohme LLC, effective December 9, 2025 (SPL set be32f468-738b-40df-a425-591e12f65159), via openFDA; the full label on DailyMed
Is there a generic for cilastatin and imipenem and relebactam (Recarbrio)?
No generic cilastatin and imipenem and relebactam is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Recarbrio injection: the compound patent runs to March 21, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is cilastatin and imipenem and relebactam in shortage?
No cilastatin and imipenem and relebactam presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated September 9, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| RECARBRIO, Injection, 500 mg/100 mL; 500 mg/100 mL; 250 mg/100 mL (NDC 0006-3856-02) | Merck Sharp & Dohme LLC | To Be Discontinued | September 9, 2026 |
Every cilastatin and imipenem and relebactam presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the cilastatin and imipenem and relebactam label say about other medicines?
The cilastatin and imipenem and relebactam label names 3 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 |
|---|---|---|
| Divalproex | drug interactions | DRUG INTERACTIONS Ganciclovir: Avoid concomitant use. ( 7.1 ) Valproic Acid or Divalproex Sodium: |
| Ganciclovir | drug interactions | DRUG INTERACTIONS Ganciclovir: Avoid concomitant use. ( 7.1 ) Valproic Acid or Divalproex Sodium: |
| Valproic acid | drug interactions | DRUG INTERACTIONS Ganciclovir: Avoid concomitant use. ( 7.1 ) Valproic Acid or Divalproex Sodium: |
Check cilastatin and imipenem and relebactam against other medicines
Source: FDA drug label (RECARBRIO), Merck Sharp & Dohme LLC, effective December 9, 2025 (SPL set be32f468-738b-40df-a425-591e12f65159), via openFDA; the full label on DailyMed
What do FAERS reports show for cilastatin and imipenem and relebactam?
The FDA Adverse Event Reporting System holds 92 reports that list cilastatin and imipenem and relebactam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 25 are coded as a death and 14 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.
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 cilastatin and imipenem and relebactam?
12 other medicines are given the same way (intravenous) and in the same FDA class as cilastatin and imipenem and relebactam 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 |
|---|---|---|---|---|
| Avibactam and ceftazidime | Urinary tract infections | none listed | n/a | No current entry |
| Ceftolozane and tazobactam | Urinary tract infections | none listed | n/a | No current entry |
| Meropenem and vaborbactam | Urinary tract infections | none listed | n/a | No current entry |
| Doxycycline | Urinary tract infections | 20 labelers | n/a | A presentation being discontinued |
| Cefazolin | Urinary tract infections | 7 labelers | $1.07 per vial 1 g vial | No current entry |
| Cefepime | Urinary tract infections | 8 labelers | n/a | A presentation being discontinued |
| Ceftriaxone | Urinary tract infections | 7 labelers | $1.44 per vial 1 g vial | No current entry |
| Plazomicin | Urinary tract infections | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as cilastatin and imipenem and relebactam
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to cilastatin and imipenem and relebactam
- 12 medicines for the same use
- Other penem antibacterials
- the pharmacologic class, with prices and generics
- Cilastatin and imipenem and relebactam side effects
- the label's list beside FAERS reports
- Cilastatin and imipenem and relebactam shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other