Atropine Sulfate Injection
NDC Package 84549-340-01

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

Package Information

Atropine Sulfate injection is a medication used before eye examinations (e.g., refraction) and to treat certain eye conditions (e.g., uveitis). This formulation utilizes a injection delivery system. Marketed by Propharma Distribution, this product is identified by NDC 84549-340 and is authorized under FDA application ANDA212461.

Identification & Billing

NDC Package Code
84549-340-01
Package Description
10 mL in 1 SYRINGE
Product Code
84549-340
11-Digit Billing Format
84549034001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Atropine Sulfate
Non-Proprietary Name
Atropine Sulfate
Substance Name
Atropine Sulfate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ATROPINE SULFATE .1 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
Propharma Distribution
Product Type
Human Prescription Drug
FDA Application #
ANDA212461
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-17-2021
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 84549-340-01 identifies a specific commercial package of 10 ml in 1 syringe of Atropine Sulfate, a human prescription drug labeled by Propharma Distribution. This injection is formulated for intravenous 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 Propharma Distribution on February 17, 2021. The current certification is valid through December 31, 2026.

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 Propharma Distribution product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84549034001. 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)
84549-340-01
11-Digit CMS (5-4-2)
84549-0340-01

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