Tropicamide
NDC Package 17478-101-12

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.

Tropicamide is a medication used to widen (dilate) the pupil of the eye in preparation for certain eye examinations. Marketed by Akorn, this product is identified by NDC 17478-101 and is authorized under FDA application ANDA040314.

Identification & Billing

NDC Package Code
17478-101-12
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER
Product Code
17478-101
11-Digit Billing Format
17478010112
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tropicamide
Dosage Form
-
Usage Information
This medication is used to widen (dilate) the pupil of the eye in preparation for certain eye examinations. It belongs to a class of drugs known as anticholinergics. Tropicamide works by relaxing certain eye muscles.

Regulatory & Marketing

Labeler Name
Akorn
FDA Application #
ANDA040314
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-29-2000
Listing Expiration
12-31-2023
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 17478-101-12 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper of Tropicamide, labeled by Akorn. 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 Akorn on September 29, 2000. The current certification is valid through December 31, 2023.

What are the primary indications for this medication?

This medication is used to widen (dilate) the pupil of the eye in preparation for certain eye examinations. It belongs to a class of drugs known as anticholinergics. Tropicamide works by relaxing certain eye muscles.

How is this Akorn product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17478010112. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
17478-101-12
11-Digit CMS (5-4-2)
17478-0101-12

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