Atropine Sulfate Solution
NDC Package 0065-0817-01

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

Package Information

Atropine Sulfate solution is a medication used before eye examinations (e.g., refraction) and to treat certain eye conditions (e.g., uveitis). This formulation utilizes a solution delivery system. Marketed by Alcon Laboratories, Inc., this product is identified by NDC 0065-0817 and is authorized under FDA application NDA208151.

Identification & Billing

NDC Package Code
0065-0817-01
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
Product Code
0065-0817
11-Digit Billing Format
00065081701
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Atropine Sulfate
Non-Proprietary Name
Atropine Sulfate
Substance Name
Atropine Sulfate
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.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
ATROPINE SULFATE 10 mg/mL
Pharmacologic Class
Usage Information
This medication is used before eye examinations (e.g., refraction) and to treat certain eye conditions (e.g., uveitis). It belongs to a class of drugs known as anticholinergics. Atropine works by widening (dilating) the pupil of the eye.

Regulatory & Marketing

Labeler Name
Alcon Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208151
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2022
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0065-0817). Click a package code to view its specific billing and regulatory data.

0065-0817-02
1 BOTTLE, DROPPER in 1 CARTON / 2 mL in 1 BOTTLE, DROPPER

* 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 0065-0817-01 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper of Atropine Sulfate, a human prescription drug labeled by Alcon Laboratories, Inc.. This solution is formulated for ophthalmic use and contains atropine sulfate 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 Alcon Laboratories, Inc. on November 01, 2022. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used before eye examinations (e.g., refraction) and to treat certain eye conditions (e.g., uveitis). It belongs to a class of drugs known as anticholinergics. Atropine works by widening (dilating) the pupil of the eye.

How is this Alcon Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00065081701. 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 (4-4-2)
0065-0817-01
11-Digit CMS (5-4-2)
00065-0817-01

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