NDC 0338-1073-02 Dobutamine Hydrochloride In Dextrose
Dobutamine Hydrochloride Injection Intravenous

Package Information

The NDC Code 0338-1073-02 is assigned to a package of 18 bag in 1 carton > 250 ml in 1 bag of Dobutamine Hydrochloride In Dextrose, a human prescription drug labeled by Baxter Healthcare Corporation. The product's dosage form is injection and is administered via intravenous form.This product is billed per "ML" milliliter and contains an estimated amount of 4500 billable units per package.

Field Name Field Value
NDC Code 0338-1073-02
Package Description 18 BAG in 1 CARTON > 250 mL in 1 BAG
Product Code 0338-1073
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Dobutamine Hydrochloride In Dextrose
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Dobutamine Hydrochloride
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
Dobutamine in 5% Dextrose Injection 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 risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
00338107302
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package 4500 ML
NDC to RxNorm Crosswalk
  • RxCUI: 309985 - DOBUTamine 250 MG in 250 ML Injection
  • RxCUI: 309985 - 250 ML dobutamine 1 MG/ML Injection
  • RxCUI: 309985 - dobutamine (as dobutamine HCl) 250 MG per 250 ML Injection
  • RxCUI: 309985 - dobutamine 250 MG per 250 ML Injection
  • RxCUI: 309986 - DOBUTamine 500 MG in 250 ML Injection
  • Product Type What kind of product is this?
    Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
    Human Prescription Drug
    Labeler Name Baxter Healthcare Corporation
    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)
    Pharmacologic Class(es)
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Marketing Category 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.
    NDA - A product marketed under an approved New Drug Application.
    FDA Application Number 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.
    NDA020255
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    09-27-1993
    Listing Expiration Date 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.
    12-31-2022
    Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
    N
    NDC 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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0338-1073-02 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00338107302J1250Inj dobutamine hcl/250 mg250 MG25018118

    * Please review the disclaimer below.