Daunorubicin Hydrochloride
NDC Package 42658-007-01

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 discontinued by the firm.

Daunorubicin Hydrochloride is a . Marketed by Hisun Pharmaceuticals Usa, Inc., this product is identified by NDC 42658-007 and is authorized under FDA application ANDA206195.

Identification & Billing

NDC Package Code
42658-007-01
Package Description
1 VIAL in 1 BOX / 4 mL in 1 VIAL
Product Code
42658-007
11-Digit Billing Format
42658000701

Clinical Specifications

Proprietary Name
Daunorubicin Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Hisun Pharmaceuticals Usa, Inc.
FDA Application #
ANDA206195
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-25-2019
End Marketing Date
09-12-2019
Listing Expiration
09-12-2019
Exclude Flag
D
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 42658-007-01 identifies a specific commercial package of 1 vial in 1 box / 4 ml in 1 vial of Daunorubicin Hydrochloride, labeled by Hisun Pharmaceuticals Usa, Inc.. 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 Hisun Pharmaceuticals Usa, Inc. on April 25, 2019. The current certification is valid through September 12, 2019.

How is this Hisun Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42658000701. 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)
42658-007-01
11-Digit CMS (5-4-2)
42658-0007-01

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