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  4. NDC Product Code: 0006-3856 Recarbrio

NDC 0006-3856 Recarbrio

Imipenem Anhydrous,Cilastatin,And Relebactam Anhydrous Injection, Powder, For Solution - View Dosage, Usage, Ingredients, Routes, UNII

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

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
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 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.
    Start Marketing Date: [9]
    01-06-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

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

    Product Packages

    NDC Code 0006-3856-02

    Package Description: 25 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01)

    Product Details

    What is NDC 0006-3856?

    The NDC code 0006-3856 is assigned by the FDA to the product Recarbrio which is a human prescription drug product labeled by Merck Sharp & Dohme Llc. The generic name of Recarbrio is imipenem anhydrous, cilastatin, and relebactam anhydrous. The product's dosage form is injection, powder, for solution and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 0006-3856-02 25 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose (0006-3856-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Recarbrio?

    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 Recarbrio Active Ingredients?

    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 Recarbrio UNII Codes?

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

    Which are Recarbrio Inactive Ingredients 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 Recarbrio?

    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 for Recarbrio?

    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.

    * Please review the disclaimer below.

    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.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".