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  5. NDC Package Code: 0143-9253-25 Dopamine Hydrochloride

NDC Package 0143-9253-25 Dopamine Hydrochloride

Injection 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:
0143-9253-25
Package Description:
25 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9253-01)
Product Code:
0143-9253
Proprietary Name:
Dopamine Hydrochloride
Non-Proprietary Name:
Dopamine Hydrochloride
Substance Name:
Dopamine Hydrochloride
Usage Information:
Dopamine Hydrochloride, USP is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma, endotoxic septicemia, open-heart surgery, renal failure, and chronic cardiac decompensation as in congestive failure.Patients most likely to respond adequately to Dopamine Hydrochloride, USP are those in whom physiological parameters, such as urine flow, myocardial function, and blood pressure, have not undergone profound deterioration. Multiclinic trials indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with blood volume correction and Dopamine Hydrochloride, USP, the better the prognosis. Where appropriate, blood volume restoration with a suitable plasma expander or whole blood should be accomplished prior to administration of Dopamine Hydrochloride, USP.Poor Perfusion of Vital Organs – Urine flow appears to be one of the better diagnostic signs by which adequacy of vital organ perfusion can be monitored. Nevertheless, the physician should also observe the patient for signs of reversal of confusion or reversal of comatose condition. Loss of pallor, increase in toe temperature, and/or adequacy of nail bed capillary filling may also be used as indices of adequate dosage. Clinical studies have shown that when Dopamine Hydrochloride, USP is administered before urine flow has diminished to levels of approximately 0.3 mL/minute, prognosis is more favorable. Nevertheless, in a number of oliguric or anuric patients, administration of Dopamine Hydrochloride, USP has resulted in an increase in urine flow, which in some cases reached normal levels. Dopamine Hydrochloride, USP may also increase urine flow in patients whose output is within normal limits and thus may be of value in reducing the degree of pre-existing fluid accumulation. It should be noted that at doses above those optimal for the individual patient, urine flow may decrease, necessitating reduction of dosage.Low Cardiac Output – Increased cardiac output is related to dopamine’s direct inotropic effect on the myocardium. Increased cardiac output at low or moderate doses appears to be related to a favorable prognosis. Increase in cardiac output has been associated with either static or decreased systemic vascular resistance (SVR). Static or decreased SVR associated with low or moderate movements in cardiac output is believed to be a reflection of differential effects on specific vascular beds with increased resistance in peripheral beds (e.g., femoral) and concomitant decreases in mesenteric and renal vascular beds.Redistribution of blood flow parallels these changes so that an increase in cardiac output is accompanied by an increase in mesenteric and renal blood flow. In many instances the renal fraction of the total cardiac output has been found to increase. Increase in cardiac output produced by dopamine is not associated with substantial decreases in systemic vascular resistance as may occur with isoproterenol.Hypotension – Hypotension due to inadequate cardiac output can be managed by administration of low to moderate doses of Dopamine Hydrochloride, USP which have little effect on SVR. At high therapeutic doses, dopamine’s alpha-adrenergic activity becomes more prominent and thus may correct hypotension due to diminished SVR. As in the case of other circulatory decompensation states, prognosis is better in patients whose blood pressure and urine flow have not undergone profound deterioration. Therefore, it is suggested that the physician administer Dopamine Hydrochloride, USP as soon as a definite trend toward decreased systolic and diastolic pressure becomes evident.
11-Digit NDC Billing Format:
00143925325
NDC to RxNorm Crosswalk:
  • RxCUI: 1743938 - DOPamine HCl 40 MG/ML in 10 ML Injection
  • RxCUI: 1743938 - 10 ML dopamine hydrochloride 40 MG/ML Injection
  • RxCUI: 1743938 - dopamine HCl 40 MG/ML per 10 ML Injection
  • RxCUI: 1743941 - DOPamine HCl 40 MG/ML in 5 ML Injection
  • RxCUI: 1743941 - 5 ML dopamine hydrochloride 40 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • DOPAMINE HYDROCHLORIDE 80 mg/mL
    • Pharmacologic Class(es):
  • Catecholamine - [EPC] (Established Pharmacologic Class)
  • Catecholamines - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA207707
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-11-2018
    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 0143-9253-25?

    The NDC Packaged Code 0143-9253-25 is assigned to a package of 25 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose (0143-9253-01) of Dopamine Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 0143-9253 included in the NDC Directory?

    Yes, Dopamine Hydrochloride with product code 0143-9253 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on April 11, 2018 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 0143-9253-25?

    The 11-digit format is 00143925325. 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 4-4-2 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
    4-4-20143-9253-255-4-200143-9253-25