Dobutamine
NDC Package 14335-172-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Dobutamine is 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. Marketed by Hainan Poly Pharm. Co., Ltd., this product is identified by NDC 14335-172 and is authorized under FDA application ANDA216131.

Identification & Billing

NDC Package Code
14335-172-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 40 mL in 1 VIAL, SINGLE-DOSE
Product Code
14335-172
11-Digit Billing Format
14335017201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dobutamine
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Hainan Poly Pharm. Co., Ltd.
FDA Application #
ANDA216131
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2021
Listing Expiration
12-31-2025
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 14335-172-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 40 ml in 1 vial, single-dose of Dobutamine, labeled by Hainan Poly Pharm. Co., Ltd.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Hainan Poly Pharm. Co., Ltd. on June 01, 2021. The current certification is valid through December 31, 2025.

How is this Hainan Poly Pharm. Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14335017201. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
14335-172-01
11-Digit CMS (5-4-2)
14335-0172-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.