NDC 67919-012-01 Cubicin Rf

Daptomycin

  1. Labeler Index
  2. Merck Sharp & Dohme Corp.
  3. 67919-012
  4. NDC Code: 67919-012-01 Cubicin Rf

NDC Package Code 67919-012-01

The NDC Code 67919-012-01 is assigned to a package of 1 vial, single-use in 1 carton > 10 ml in 1 vial, single-use of Cubicin Rf, a human prescription drug labeled by Merck Sharp & Dohme Corp.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

Field Name Field Value
NDC Code 67919-012-01
Package Description 1 VIAL, SINGLE-USE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-USE
Proprietary Name Cubicin Rf What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Daptomycin 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.
Drug Uses 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.
11-Digit NDC Billing Format 67919001201 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Product Type Human Prescription Drug 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.
Labeler Name Merck Sharp & Dohme Corp.
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)
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
  • DAPTOMYCIN 500 mg/10mL
  • DAPTOMYCIN 500 mg/10mL
Pharmacological Class(es)
  • Lipopeptide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Lipopeptides - [CS]
  • Lipopeptide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Lipopeptides - [CS]
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. 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.
FDA Application Number NDA021572 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.
Start Marketing Date 07-06-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 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.
Exclude Flag N 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".

NDC Code Structure

  • 67919 - Merck Sharp & Dohme Corp.
    • 67919-012 - Cubicin Rf
      • 67919-012-01 - 1 VIAL, SINGLE-USE in 1 CARTON

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 67919-012-01 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
67919001201J0878Daptomycin injection1 MG11500500

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Other Product Packages

The following packages are also available for Cubicin Rf with product NDC 67919-012.

NDC Package CodePackage Description
67919-012-021 VIAL, SINGLE-USE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-USE

* Please review the disclaimer below.