Dopamine Hci In 5% Dextrose
NDC 51662-1458

View dosage, usage, ingredients, routes, and UNII mappings.

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Dopamine Hci In 5% Dextrose is a NDA-approved product labeled by Hf Acquisition Co Llc, Dba Healthfirst. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 51662-1458 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
51662-1458
Proprietary Name:
Dopamine Hci In 5% Dextrose
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Code:
51662
HCPCS Code:
J1265 - Dopamine injection
FDA Application Number: [6]
NDA018826
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
12-12-2019
End Marketing Date: [10]
05-01-2024
Listing Expiration Date: [11]
05-01-2024
Exclude Flag: [12]
D

Code Structure Chart

Product Details

What is NDC 51662-1458?

The NDC code 51662-1458 is assigned by the FDA to the product Dopamine Hci In 5% Dextrose. This pharmaceutical product is labeled by Hf Acquisition Co Llc, Dba Healthfirst and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 51662-1458-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Dopamine Hydrochloride in 5% Dextrose Injection, USP is indicated for the correction of hemodynamic imbalances present in shock due to myocardial infarction, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in refractory congestive failure.When indicated, restoration of circulatory volume should be instituted or completed with a suitable plasma expander or whole blood, prior to administration of dopamine hydrochloride.Patients most likely to respond to dopamine are those whose physiological parameters (such as urine flow, myocardial function and blood pressure) have not undergone extreme deterioration. Reports indicate that the shorter the time between onset of signs and symptoms and initiation of therapy with volume restoration and dopamine, the better the prognosis.Poor Perfusion of Vital Organs: Although urine flow is apparently one of the better diagnostic signs for monitoring vital organ perfusion, the physician also should observe the patient for signs of reversal of mental confusion or coma. Loss of pallor, increase in toe temperature or adequacy of nail bed capillary filling also may be observed as indices of adequate dosage. Reported studies indicate that when dopamine is administered before urine flow has decreased to approximately 0.3 mL/minute prognosis is more favorable.However, it has been observed that in some oliguric or anuric patients, administration of the drug has produced an increase in urine flow which may reach normal levels. The drug also may increase urine flow in patients whose output is within normal limits and thus may help in reducing the degree of pre-existing fluid accumulation. Conversely, at higher than optimal doses for a given patient, urinary flow may decrease, requiring a reduction of dosage. Concomitant administration of dopamine and diuretic agents may produce an additive or potentiating effect.Low Cardiac Output: Dopamine's direct inotropic effect on the myocardium which increases cardiac output at low or moderate doses is related to a favorable prognosis. Increased output has been associated with unchanged or decreased systemic vascular resistance (SVR). The association of static or decreased SVR with low or moderate increases in cardiac output is regarded as a reflection of differential effects on specific vascular beds, with increased resistance in peripheral beds (e.g., femoral), and concurrent 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: Low to moderate doses of dopamine, which have little effect on SVR, can be used to manage hypotension due to inadequate cardiac output. At high therapeutic doses, dopamine's α-adrenergic action becomes more prominent and thus may correct hypotension due to diminished SVR. As in other circulatory decompensation states, prognosis is better in patients whose blood pressure and urine flow have not undergone extreme deterioration. Therefore, it is suggested the physician administer dopamine as soon as a definite trend toward decreased systolic and diastolic pressure becomes apparent.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".