Ranibizumab Solution, Concentrate
NDC Package 82775-100-01

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 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 solution is a medication used to treat certain serious eye conditions (such as age-related macular degeneration, macular edema, diabetic retinopathy). This formulation utilizes a solution, concentrate delivery system. Marketed by Polpharma Biologics Sa, this product is identified by NDC 82775-100.

Identification & Billing

NDC Package Code
82775-100-01
Package Description
1000 g in 1 BOTTLE
Product Code
82775-100
11-Digit Billing Format
82775010001

Clinical Specifications

Proprietary Name
Ranibizumab
Non-Proprietary Name
Ranibizumab
Substance Name
Ranibizumab
Dosage Form
Solution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
Active Ingredient(s)
RANIBIZUMAB 1 g/g
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
Polpharma Biologics Sa
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
06-09-2022
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 82775-100-01 identifies a specific commercial package of 1000 g in 1 bottle of Ranibizumab (UNFINISHED drug), a bulk ingredient labeled by Polpharma Biologics Sa. This solution, concentrate 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 Polpharma Biologics Sa on June 09, 2022. The current certification is valid through December 31, 2026.

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 Polpharma Biologics Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82775010001. 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)
82775-100-01
11-Digit CMS (5-4-2)
82775-0100-01

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