Daptomycin In Sodium Chloride Injection, Solution
NDC Package 0338-0718-12

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

Package Information

Daptomycin In Sodium Chloride injection is a medication an antibiotic used to treat serious bacterial infections. This formulation utilizes a injection, solution delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-0718 and is authorized under FDA application NDA213645.

Identification & Billing

NDC Package Code
0338-0718-12
Package Description
12 BAG in 1 CARTON / 100 mL in 1 BAG
Product Code
0338-0718
11-Digit Billing Format
00338071812
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Daptomycin In Sodium Chloride
Non-Proprietary Name
Daptomycin In Sodium Chloride
Substance Name
Daptomycin
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DAPTOMYCIN 1000 mg/100mL
Pharmacologic Class
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
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA213645
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-25-2022
Listing Expiration
12-31-2027
Exclude Flag
N
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 0338-0718-12 identifies a specific commercial package of 12 bag in 1 carton / 100 ml in 1 bag of Daptomycin In Sodium Chloride, a human prescription drug labeled by Baxter Healthcare Corporation. This injection, solution is formulated for intravenous use and contains daptomycin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Baxter Healthcare Corporation on January 25, 2022. The current certification is valid through December 31, 2027.

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 Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338071812. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0338-0718-12
11-Digit CMS (5-4-2)
00338-0718-12

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