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  5. NDC Package Code: 14335-171-01 Dobutamine

NDC Package 14335-171-01 Dobutamine

Injection, Solution, Concentrate 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:
14335-171-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE
Product Code:
14335-171
Proprietary Name:
Dobutamine
Non-Proprietary Name:
Dobutamine
Substance Name:
Dobutamine Hydrochloride
Usage Information:
Dobutamine Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions.Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risk of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.
11-Digit NDC Billing Format:
14335017101
NDC to RxNorm Crosswalk:
  • RxCUI: 1812168 - DOBUTamine 250 MG in 20 ML Injection
  • RxCUI: 1812168 - 20 ML dobutamine 12.5 MG/ML Injection
  • RxCUI: 1812168 - dobutamine (as dobutamine HCl) 250 MG per 20 ML Injection
  • RxCUI: 1812168 - dobutamine 250 MG per 20 ML Injection
  • RxCUI: 1812170 - DOBUTamine 500 MG in 40 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hainan Poly Pharm. Co., Ltd.
    Dosage Form:
    Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • DOBUTAMINE HYDROCHLORIDE 12.5 mg/mL
    • Pharmacologic Class(es):
  • Adrenergic beta-Agonists - [MoA] (Mechanism of Action)
  • beta-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA216131
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-01-2021
    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.

    Frequently Asked Questions

    What is NDC 14335-171-01?

    The NDC Packaged Code 14335-171-01 is assigned to a package of 1 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose of Dobutamine, a human prescription drug labeled by Hainan Poly Pharm. Co., Ltd.. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

    Is NDC 14335-171 included in the NDC Directory?

    Yes, Dobutamine with product code 14335-171 is active and included in the NDC Directory. The product was first marketed by Hainan Poly Pharm. Co., Ltd. on June 01, 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 14335-171-01?

    The 11-digit format is 14335017101. 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
    5-3-214335-171-015-4-214335-0171-01