Atropine Sulfate Injection, Solution
NDC Package 64253-400-91

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

Package Information

Atropine Sulfate (atropine sulfate injection) 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, solution delivery system. Marketed by Medefil, Inc., this product is identified by NDC 64253-400 and is authorized under FDA application ANDA214970.

Identification & Billing

NDC Package Code
64253-400-91
Package Description
10 SYRINGE, PLASTIC in 1 BOX / 10 mL in 1 SYRINGE, PLASTIC (64253-400-30)
Product Code
64253-400
11-Digit Billing Format
64253040091
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 Injection
Substance Name
Atropine Sulfate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
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
Medefil, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA214970
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-11-2023
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 64253-400-91 identifies a specific commercial package of 10 syringe, plastic in 1 box / 10 ml in 1 syringe, plastic (64253-400-30) of Atropine Sulfate, a human prescription drug labeled by Medefil, Inc.. This injection, solution 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 Medefil, Inc. on May 11, 2023. 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 Medefil, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64253040091. 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)
64253-400-91
11-Digit CMS (5-4-2)
64253-0400-91

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