NDC Package 71288-016-15 Daptomycin

Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
71288-016-15
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code:
Proprietary Name:
Daptomycin
Non-Proprietary Name:
Daptomycin
Substance Name:
Daptomycin
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.
11-Digit NDC Billing Format:
71288001615
NDC to RxNorm Crosswalk:
  • RxCUI: 403920 - DAPTOmycin 500 MG Injection
  • RxCUI: 403920 - daptomycin 500 MG Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Meitheal Pharmaceuticals Inc.
    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.
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    ANDA213623
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-29-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 this product:

    NDC Package CodePackage Description
    71288-016-911 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
    71288-016-951 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71288-016-15?

    The NDC Packaged Code 71288-016-15 is assigned to a package of 1 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose of Daptomycin, a human prescription drug labeled by Meitheal Pharmaceuticals Inc.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

    Is NDC 71288-016 included in the NDC Directory?

    Yes, Daptomycin with product code 71288-016 is active and included in the NDC Directory. The product was first marketed by Meitheal Pharmaceuticals Inc. on June 29, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 71288-016-15?

    The 11-digit format is 71288001615. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-271288-016-155-4-271288-0016-15