NDC 76233-091-01 Daptomycin

Daptomycin

  1. Labeler Index
  2. Laboratorio Reig Jofre, S.a.
  3. 76233-091
  4. NDC Code: 76233-091-01 Daptomycin

NDC Package Code 76233-091-01

The NDC Code 76233-091-01 is assigned to a package of 1 vial, single-use in 1 carton > 20 ml in 1 vial, single-use of Daptomycin, a human prescription drug labeled by Laboratorio Reig Jofre, S.a.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

Field Name Field Value
NDC Code 76233-091-01
Package Description 1 VIAL, SINGLE-USE in 1 CARTON > 20 mL in 1 VIAL, SINGLE-USE
Proprietary Name Daptomycin 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 76233009101 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 Laboratorio Reig Jofre, S.a.
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.
Active Ingredient(s)
  • DAPTOMYCIN 500 mg/10mL
Pharmacological Class(es)
  • 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 ANDA - A product marketed under an approved Abbreviated 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 ANDA210057 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 02-03-2021 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 12-31-2021 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

  • 76233 - Laboratorio Reig Jofre, S.a.
    • 76233-091 - Daptomycin
      • 76233-091-01 - 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.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for Daptomycin with product NDC 76233-091.

NDC Package CodePackage Description
76233-091-055 VIAL, SINGLE-USE in 1 CARTON > 20 mL in 1 VIAL, SINGLE-USE

* Please review the disclaimer below.