Daptomycin
NDC Package 45932-0039-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Daptomycin is a medication an antibiotic used to treat serious bacterial infections. Marketed by Xellia Pharmaceuticals Usa, Llc, this product is identified by NDC 45932-0039 and is authorized under FDA application NDA209949.

Identification & Billing

NDC Package Code
45932-0039-1
Package Description
1 VIAL in 1 CARTON / 7 mL in 1 VIAL
Product Code
45932-0039
11-Digit Billing Format
45932003901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Daptomycin
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
Xellia Pharmaceuticals Usa, Llc
FDA Application #
NDA209949
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-19-2018
Listing Expiration
12-31-2020
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 45932-0039-1 identifies a specific commercial package of 1 vial in 1 carton / 7 ml in 1 vial of Daptomycin, labeled by Xellia Pharmaceuticals Usa, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Xellia Pharmaceuticals Usa, Llc on July 19, 2018. The current certification is valid through December 31, 2020.

What are the primary indications for this medication?

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.

How is this Xellia Pharmaceuticals Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45932003901. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
45932-0039-1
11-Digit CMS (5-4-2)
45932-0039-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.