Diluent Solution
NDC Package 61434-011-00

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.

Diluent solution is a medication used to relieve dry, irritated eyes. This formulation utilizes a solution delivery system. Marketed by Catalent Indiana, Llc, this product is identified by NDC 61434-011.

Identification & Billing

NDC Package Code
61434-011-00
Package Description
5 mL in 1 VIAL
Product Code
61434-011
11-Digit Billing Format
61434001100

Clinical Specifications

Proprietary Name
Diluent
Non-Proprietary Name
Diluent
Substance Name
Carboxymethylcellulose Sodium
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)
CARBOXYMETHYLCELLULOSE SODIUM 25 mg/5mL
Usage Information
This medication is used to relieve dry, irritated eyes. Common causes for dry eyes include wind, sun, heating/air conditioning, computer use/reading, and certain medications. This product may contain 1 or more of the following ingredients: carboxymethylcellulose, dextran, glycerin, hypromellose, polyethylene glycol 400 (PEG 400), polysorbate, polyvinyl alcohol, povidone, or propylene glycol, among others. Eye lubricants keep the eye moist, help to protect the eye from injury and infection, and decrease symptoms of dry eyes such as burning, itching, and feeling as if something is in the eye.

Regulatory & Marketing

Labeler Name
Catalent Indiana, Llc
Product Type
Human Prescription Drug
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
10-06-2017
End Marketing Date
03-31-2028
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 61434-011-00 identifies a specific commercial package of 5 ml in 1 vial of Diluent (UNFINISHED drug), a human prescription drug labeled by Catalent Indiana, Llc. This solution is formulated for use and contains carboxymethylcellulose sodium 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 Catalent Indiana, Llc on October 06, 2017.

What are the primary indications for this medication?

This medication is used to relieve dry, irritated eyes. Common causes for dry eyes include wind, sun, heating/air conditioning, computer use/reading, and certain medications. This product may contain 1 or more of the following ingredients: carboxymethylcellulose, dextran, glycerin, hypromellose, polyethylene glycol 400 (PEG 400), polysorbate, polyvinyl alcohol, povidone, or propylene glycol, among others. Eye lubricants keep the eye moist, help to protect the eye from injury and infection, and decrease symptoms of dry eyes such as burning, itching, and feeling as if something is in the eye.

How is this Catalent Indiana, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61434001100. 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)
61434-011-00
11-Digit CMS (5-4-2)
61434-0011-00

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