Prednisolone Acetate Suspension/ Drops
NDC Package 67296-2176-5

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Prednisolone Acetate suspension/ dropses is a medication used to treat certain eye conditions due to inflammation or injury. This formulation utilizes a suspension/ drops delivery system. Marketed by Redpharm Drug, this product is identified by NDC 67296-2176 and is authorized under FDA application ANDA216935.

Identification & Billing

NDC Package Code
67296-2176-5
Package Description
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
Product Code
67296-2176
11-Digit Billing Format
67296217605

Clinical Specifications

Proprietary Name
Prednisolone Acetate
Non-Proprietary Name
Prednisolone Acetate
Substance Name
Prednisolone Acetate
Dosage Form
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
PREDNISOLONE ACETATE 10 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat certain eye conditions due to inflammation or injury. Prednisolone works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.

Regulatory & Marketing

Labeler Name
Redpharm Drug
Product Type
Human Prescription Drug
FDA Application #
ANDA216935
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-11-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 67296-2176-5 identifies a specific commercial package of 1 bottle in 1 carton / 5 ml in 1 bottle of Prednisolone Acetate, a human prescription drug labeled by Redpharm Drug. This suspension/ drops is formulated for ophthalmic use and contains prednisolone acetate 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 Redpharm Drug on October 11, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain eye conditions due to inflammation or injury. Prednisolone works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.

How is this Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296217605. 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 (5-4-1)
67296-2176-5
11-Digit CMS (5-4-2)
67296-2176-05

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