Daptomycin Injection, Powder, Lyophilized, For Suspension
NDC Package 70436-033-80

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

Package Information

Daptomycin injection is a medication an antibiotic used to treat serious bacterial infections. This formulation utilizes a injection, powder, lyophilized, for suspension delivery system. Marketed by Slate Run Pharmaceuticals, Llc, this product is identified by NDC 70436-033 and is authorized under FDA application ANDA215890.

Identification & Billing

NDC Package Code
70436-033-80
Package Description
20 mL in 1 VIAL, SINGLE-DOSE
Product Code
70436-033
11-Digit Billing Format
70436003380
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Daptomycin
Non-Proprietary Name
Daptomycin
Substance Name
Daptomycin
Dosage Form
Injection, Powder, Lyophilized, For Suspension - A liquid preparation, intended for parenteral use that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DAPTOMYCIN 500 mg/20mL
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
Slate Run Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA215890
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2022
Listing Expiration
12-31-2026
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 70436-033-80 identifies a specific commercial package of 20 ml in 1 vial, single-dose of Daptomycin, a human prescription drug labeled by Slate Run Pharmaceuticals, Llc. This injection, powder, lyophilized, for suspension 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 Slate Run Pharmaceuticals, Llc on October 01, 2022. The current certification is valid through December 31, 2026.

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 Slate Run Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70436003380. 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 (5-3-2)
70436-033-80
11-Digit CMS (5-4-2)
70436-0033-80

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