Ranibizumab Injection, Solution
NDC Package 71082-110-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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.

Ranibizumab injection is a medication used to treat certain serious eye conditions (such as age-related macular degeneration, macular edema, diabetic retinopathy). This formulation utilizes a injection, solution delivery system. Marketed by Frueh Verpackungstechnik Ag, this product is identified by NDC 71082-110.

Identification & Billing

NDC Package Code
71082-110-10
Package Description
1 SYRINGE, GLASS in 1 BLISTER PACK / .05 mL in 1 SYRINGE, GLASS
Product Code
71082-110
11-Digit Billing Format
71082011010

Clinical Specifications

Proprietary Name
Ranibizumab
Non-Proprietary Name
Ranibizumab
Substance Name
Ranibizumab
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Active Ingredient(s)
RANIBIZUMAB 10 mg/mL
Usage Information
This medication is used to treat certain serious eye conditions (such as age-related macular degeneration, macular edema, diabetic retinopathy). It is used to help prevent decreased vision and blindness. Ranibizumab works by slowing the growth of abnormal new blood vessels in the eye and decreasing leakage from these blood vessels.

Regulatory & Marketing

Labeler Name
Frueh Verpackungstechnik Ag
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
10-13-2016
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71082-110). Click a package code to view its specific billing and regulatory data.

71082-110-11
1 SYRINGE, GLASS in 1 BLISTER PACK / .05 mL in 1 SYRINGE, GLASS

* 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 71082-110-10 identifies a specific commercial package of 1 syringe, glass in 1 blister pack / .05 ml in 1 syringe, glass of Ranibizumab (UNFINISHED drug), drug for further processing labeled by Frueh Verpackungstechnik Ag. This injection, solution is formulated for use and contains ranibizumab 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 Frueh Verpackungstechnik Ag on October 13, 2016. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat certain serious eye conditions (such as age-related macular degeneration, macular edema, diabetic retinopathy). It is used to help prevent decreased vision and blindness. Ranibizumab works by slowing the growth of abnormal new blood vessels in the eye and decreasing leakage from these blood vessels.

How is this Frueh Verpackungstechnik Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71082011010. 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)
71082-110-10
11-Digit CMS (5-4-2)
71082-0110-10

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