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NDC 60977-145 Dapzura Rt

Daptomycin Injection, Powder, Lyophilized, For Solution Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 60977-145?
  5. Dapzura Rt 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:
60977-145
Proprietary Name:
Dapzura Rt
Non-Proprietary Name: [1]
Daptomycin
Substance Name: [2]
Daptomycin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Baxter Healthcare Corporation
    Labeler Code:
    60977
    Product Label ID:
    cb1283e1-35b8-425c-b338-d9ac0c7161f8
    FDA Application Number: [6]
    NDA213645
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    01-25-2022
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - PALE YELLOW TO LIGHT BROWN)

    Code Structure Chart

    Product Details

    What is NDC 60977-145?

    The NDC code 60977-145 is assigned by the FDA to the product Dapzura Rt which is a human prescription drug product labeled by Baxter Healthcare Corporation. The generic name of Dapzura Rt is daptomycin. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 60977-145-01 1 vial in 1 carton / 10 ml in 1 vial. 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 Dapzura Rt?

    This medication is an antibiotic used to treat serious bacterial infections. It works by stopping the growth of bacteria. This medication is not recommended for use in children younger than 12 months due to possible risk of serious side effects.

    What are Dapzura Rt 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.

    Which are Dapzura Rt UNII Codes?

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

    Which are Dapzura Rt 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 Dapzura Rt?

    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:

    Which are the Pharmacologic Classes for Dapzura Rt?

    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

    Daptomycin Injection


    Daptomycin injection is used to treat certain blood infections or serious skin infections caused by bacteria in adults and children 1 year of age and older. Daptomycin injection is in a class of medications called cyclic lipopeptide antibiotics. It works by killing bacteria. Antibiotics such as daptomycin injection will not work for treating colds, flu, or other viral infections. 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".