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  5. NDC Package Code: 14335-120-01 Daptomycin

NDC Package 14335-120-01 Daptomycin

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

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
14335-120-01
Package Description:
20 mL in 1 VIAL, SINGLE-DOSE
Product Code:
14335-120
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:
14335012001
NDC to RxNorm Crosswalk:
  • RxCUI: 403920 - DAPTOmycin 500 MG Injection
  • RxCUI: 403920 - daptomycin 500 MG Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hainan Poly Pharm., Co., Ltd.
    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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • DAPTOMYCIN 500 mg/20mL
    • Pharmacologic Class(es):
  • Lipopeptide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Lipopeptides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA215890
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-14-2023
    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.

    Frequently Asked Questions

    What is NDC 14335-120-01?

    The NDC Packaged Code 14335-120-01 is assigned to a package of 20 ml in 1 vial, single-dose of Daptomycin, a human prescription drug labeled by Hainan Poly Pharm., Co., Ltd.. The product's dosage form is injection, powder, lyophilized, for suspension and is administered via intravenous form.

    Is NDC 14335-120 included in the NDC Directory?

    Yes, Daptomycin with product code 14335-120 is active and included in the NDC Directory. The product was first marketed by Hainan Poly Pharm., Co., Ltd. on November 14, 2023 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 14335-120-01?

    The 11-digit format is 14335012001. 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
    5-3-214335-120-015-4-214335-0120-01