Atropine Sulfate Solution
NDC Package 82260-001-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Bausch & Lomb Americas Inc., this product is identified by NDC 82260-001 and is authorized under FDA application NDA213581.

Identification & Billing

NDC Package Code
82260-001-01
Package Description
10 VIAL in 1 CARTON / .4 mL in 1 VIAL
Product Code
82260-001
11-Digit Billing Format
82260000101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
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
Bausch & Lomb Americas Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA213581
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
04-21-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82260-001-01 identifies a specific commercial package of 10 vial in 1 carton / .4 ml in 1 vial of Atropine Sulfate, a human prescription drug labeled by Bausch & Lomb Americas Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Bausch & Lomb Americas Inc. on April 21, 2023. 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 Bausch & Lomb Americas Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82260000101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
82260-001-01
11-Digit CMS (5-4-2)
82260-0001-01

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