NDC Package 12064-019-01 Doxorubicin Hydrochloride

Injection, Suspension, Liposomal - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:

12064-019-01

Package Description:

50 VIAL in 1 CASE / 25 mL in 1 VIAL

Product Code:

12064-019

Non-Proprietary Name:

Doxorubicin Hydrochloride

Substance Name:

Doxorubicin Hydrochloride

11-Digit NDC Billing Format:

12064001901

Product Type:

Drug For Further Processing

Labeler Name:

Glaxosmithkline Manufacturing Spa

Dosage Form:

Injection, Suspension, Liposomal - A liquid preparation, suitable for injection, which consists of an oil phase dispersed throughout an aqueous phase in such a manner that liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance, either within a lipid bilayer or in an aqueous space) are formed.

Active Ingredient(s):

DOXORUBICIN HYDROCHLORIDE 2 mg/mL

Sample Package:

N/A

Marketing Category:

DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.

Start Marketing Date:

01-01-2015

Listing Expiration Date:

12-31-2024

Exclude Flag:

Unfinished Product:

Yes

Code Structure:

12064 - Glaxosmithkline Manufacturing Spa
- 12064-019 -
  - 12064-019-01 - 50 VIAL in 1 CASE / 25 mL in 1 VIAL

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
12064-019-00	98 VIAL in 1 CASE / 10 mL in 1 VIAL

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 12064-019-01?

The NDC Packaged Code 12064-019-01 is assigned to an UNFINISHED drug package of 50 vial in 1 case / 25 ml in 1 vial of Doxorubicin Hydrochloride, drug for further processing labeled by Glaxosmithkline Manufacturing Spa. The product's dosage form is injection, suspension, liposomal and is administered via form.

Is NDC 12064-019 included in the NDC Directory?

Yes, Doxorubicin Hydrochloride is an UNFINISHED PRODUCT with code 12064-019 that is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Manufacturing Spa on January 01, 2015 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 12064-019-01?

The 11-digit format is 12064001901. 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 5-3-2 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	12064-019-01	5-4-2	12064-0019-01

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