Palivizumab Solution
NDC Package 12714-232-10

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 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.

Palivizumab solution is palivizumab is used in certain infants and young children to prevent serious lung infections (such as pneumonia) that are caused by a certain virus (respiratory syncytial virus-RSV). This formulation utilizes a solution delivery system. Marketed by Boehringer Ingelheim Pharma Gmbh And Co. Kg, this product is identified by NDC 12714-232.

Identification & Billing

NDC Package Code
12714-232-10
Package Description
100 mg in 1 VIAL, SINGLE-DOSE
Product Code
12714-232
11-Digit Billing Format
12714023210

Clinical Specifications

Proprietary Name
Palivizumab
Non-Proprietary Name
Palivizumab
Substance Name
Palivizumab
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Active Ingredient(s)
PALIVIZUMAB 100 mg/100mg
Usage Information
Palivizumab is used in certain infants and young children to prevent serious lung infections (such as pneumonia) that are caused by a certain virus (respiratory syncytial virus-RSV). Palivizumab works by preventing the growth of the virus. This medication is not used to treat RSV infection, but should be continued even if your child gets the RSV infection to prevent a more serious infection.

Regulatory & Marketing

Labeler Name
Boehringer Ingelheim Pharma Gmbh And Co. Kg
Product Type
Drug For Further Processing
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
06-24-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 12714-232-10 identifies a specific commercial package of 100 mg in 1 vial, single-dose of Palivizumab (UNFINISHED drug), drug for further processing labeled by Boehringer Ingelheim Pharma Gmbh And Co. Kg. This solution is formulated for use and contains palivizumab as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Boehringer Ingelheim Pharma Gmbh And Co. Kg on June 24, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Palivizumab is used in certain infants and young children to prevent serious lung infections (such as pneumonia) that are caused by a certain virus (respiratory syncytial virus-RSV). Palivizumab works by preventing the growth of the virus. This medication is not used to treat RSV infection, but should be continued even if your child gets the RSV infection to prevent a more serious infection.

How is this Boehringer Ingelheim Pharma Gmbh And Co. Kg product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12714023210. 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)
12714-232-10
11-Digit CMS (5-4-2)
12714-0232-10

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