Dapiprazole
NDC Package 53020-265-01

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Dapiprazole is hydrochloride ophthalmic solution is indicated in the treatment of iatrogenically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents. Marketed by Baradaina, Llc, this product is identified by NDC 53020-265 and is authorized under FDA application ANDA204902.

Identification & Billing

NDC Package Code
53020-265-01
Package Description
1 KIT in 1 CARTON * 5 mL in 1 VIAL (53020-255-01) * 5 mL in 1 VIAL (53020-245-01)
Product Code
53020-265
11-Digit Billing Format
53020026501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dapiprazole
Dosage Form
-
Usage Information
Dapiprazole hydrochloride ophthalmic solution is indicated in the treatment of iatrogenically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents. Dapiprazole hydrochloride ophthalmic solution is not indicated for the reduction of intraocular pressure or in the treatment of open angle glaucoma.

Regulatory & Marketing

Labeler Name
Baradaina, Llc
FDA Application #
ANDA204902
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-31-2019
Listing Expiration
12-31-2025
Exclude Flag
I
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 53020-265-01 identifies a specific commercial package of 1 kit in 1 carton * 5 ml in 1 vial (53020-255-01) * 5 ml in 1 vial (53020-245-01) of Dapiprazole, labeled by Baradaina, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Baradaina, Llc on July 31, 2019. The current certification is valid through December 31, 2025.

How is this Baradaina, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53020026501. 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)
53020-265-01
11-Digit CMS (5-4-2)
53020-0265-01

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