Recarbrio Injection, Powder, For Solution
NDC 0006-3856

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0006-3856?
  5. Recarbrio Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Recarbrio (imipenem anhydrous, cilastatin, and relebactam anhydrous) is a NDA-approved product labeled by Merck Sharp & Dohme Llc. This medication is typically used as a carbapenems [cs]. It is supplied as a white injection, powder, for solution for intravenous administration. This product entry covers the primary NDC 0006-3856 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0006-3856
Proprietary Name:
Recarbrio
Non-Proprietary Name: [1]
Imipenem Anhydrous, Cilastatin, And Relebactam Anhydrous
Substance Name: [2]
Cilastatin; Imipenem Anhydrous; Relebactam Anhydrous
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route(s): [4]
Intravenous - Administration within or into a vein or veins.

Labeler & Regulatory Data

Labeler Name: [5]
Merck Sharp & Dohme Llc
Labeler Code:
0006
Product Label ID:
be32f468-738b-40df-a425-591e12f65159
FDA Application Number: [6]
NDA212819
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
01-06-2020
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO LIGHT YELLOW)

Code Structure Chart

Product Details

What is NDC 0006-3856?

The NDC code 0006-3856 is assigned by the FDA to the product Recarbrio. It is commonly known by its generic name, imipenem anhydrous, cilastatin, and relebactam anhydrous. This pharmaceutical product is labeled by Merck Sharp & Dohme Llc and is currently categorized as listed product. The medication is a injection, powder, for solution administered via intravenous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0006-3856-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity (severe systemic allergic reaction such as anaphylaxis) to any component of RECARBRIO.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • CILASTATIN 500 mg/100mL - A renal dehydropeptidase-I and leukotriene D4 dipeptidase inhibitor. Since the antibiotic, IMIPENEM, is hydrolyzed by dehydropeptidase-I, which resides in the brush border of the renal tubule, cilastatin is administered with imipenem to increase its effectiveness. The drug also inhibits the metabolism of leukotriene D4 to leukotriene E4.
  • IMIPENEM ANHYDROUS 500 mg/100mL - Semisynthetic thienamycin that has a wide spectrum of antibacterial activity against gram-negative and gram-positive aerobic and anaerobic bacteria, including many multiresistant strains. It is stable to beta-lactamases. Clinical studies have demonstrated high efficacy in the treatment of infections of various body systems. Its effectiveness is enhanced when it is administered in combination with CILASTATIN, a renal dipeptidase inhibitor.
  • RELEBACTAM ANHYDROUS 250 mg/100mL

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 2184142 - cilastatin 500 MG / imipenem 500 MG / relebactam 250 MG Injection
  • RxCUI: 2184147 - Recarbrio 500 MG / 500 MG / 250 MG Injection
  • RxCUI: 2184147 - cilastatin 500 MG / imipenem 500 MG / relebactam 250 MG Injection [Recarbrio]
  • RxCUI: 2184147 - Recarbrio 1.25 GM Injection

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Imipenem, Cilastatin, and Relebactam Injection


Imipenem, cilastatin, and relebactam injection is used to treat adults with certain serious urinary tract infections including kidney infections, and certain serious abdominal (stomach) infections when there are few or no other treatment options. It is also used to treat certain types of pneumonia that developed in adults who are on ventilators or who were already in a hospital. Imipenem is in a class of medications called carbapenem antibiotics. It works by killing bacteria. Cilastatin is in a class of medications called dehydropeptidase inhibitors. It works by helping imipenem stay active in your body for a longer period of time. Relebactam is in a class of medications called beta-lactamase inhibitors. It works by preventing bacteria from destroying imipenem. Antibiotics such as imipenem, cilastatin, and relebactam injection will not work for colds, flu, or other viral infections. Taking or using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".