Dalbavancin Injection, Powder, Lyophilized, For Solution
NDC Package 71288-034-50

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

Package Information

Dalbavancin injection is dalbavancin for injection is contraindicated in patients with known hypersensitivity to dalbavancin. . This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Meitheal Pharmaceuticals Inc, this product is identified by NDC 71288-034 and is authorized under FDA application ANDA218929.

Identification & Billing

NDC Package Code
71288-034-50
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 25 mL in 1 VIAL, SINGLE-DOSE
Product Code
71288-034
11-Digit Billing Format
71288003450
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dalbavancin
Non-Proprietary Name
Dalbavancin
Substance Name
Dalbavancin Hydrochloride
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DALBAVANCIN HYDROCHLORIDE 500 mg/25mL
Pharmacologic Class
Usage Information
Dalbavancin for injection is contraindicated in patients with known hypersensitivity to dalbavancin. 

Regulatory & Marketing

Labeler Name
Meitheal Pharmaceuticals Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA218929
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-26-2025
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 71288-034-50 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 25 ml in 1 vial, single-dose of Dalbavancin, a human prescription drug labeled by Meitheal Pharmaceuticals Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains dalbavancin hydrochloride 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 Meitheal Pharmaceuticals Inc on November 26, 2025. The current certification is valid through December 31, 2026.

How is this Meitheal Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71288003450. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
71288-034-50
11-Digit CMS (5-4-2)
71288-0034-50

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