N/a Injection
NDC Package 71053-591-01

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

Package Information

N/a (atropine sulfate injection usp, 1 mg/0.7 ml) injection is atropine Sulfate Injection USP is indicated for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides. This formulation utilizes a injection delivery system. Marketed by Rafa Laboratories, Ltd., this product is identified by NDC 71053-591.

Identification & Billing

NDC Package Code
71053-591-01
Package Description
.7 mL in 1 SYRINGE
Product Code
71053-591
11-Digit Billing Format
71053059101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
N/a
Non-Proprietary Name
Atropine Sulfate Injection Usp, 1 Mg/0.7 Ml
Substance Name
Atropine
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
ATROPINE 1 mg/.7mL
Pharmacologic Class
Usage Information
Atropine Sulfate Injection USP is indicated for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides. Atropine Sulfate Injection USP should be used by persons who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication. Pralidoxime chloride may serve as an important adjunct to atropine therapy.Atropine Sulfate Injection USP is intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings (generally breathing difficulties due to increased secretions); definitive medical care should be sought immediately. Atropine Sulfate Injection USP should be administered as soon as symptoms of organophosphorous or carbamate poisoning appear (usually tearing, excessive oral secretions, wheezing, muscle fasciculations, etc.). In moderate to severe poisoning, the administration of more than one Atropine Sulfate Injection USP injection may be required until atropinization is achieved (flushing, mydriasis, tachycardia, dryness of the mouth and nose). In severe poisonings, it may also be desirable to concurrently administer an anticonvulsant if seizure is suspected in the unconscious individual since the classic tonic-clonic jerking may not be apparent due to the effects of the poison. In poisonings due to organophosphorous nerve agents and insecticides it may also be helpful to concurrently administer a cholinesterase reactivator such as pralidoxime chloride.

Regulatory & Marketing

Labeler Name
Rafa Laboratories, Ltd.
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
03-09-2018
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 71053-591-01 identifies a specific commercial package of .7 ml in 1 syringe of N/a, a human prescription drug labeled by Rafa Laboratories, Ltd.. This injection is formulated for intramuscular use and contains atropine 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 Rafa Laboratories, Ltd. on March 09, 2018. The current certification is valid through December 31, 2027.

How is this Rafa Laboratories, Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71053059101. 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)
71053-591-01
11-Digit CMS (5-4-2)
71053-0591-01

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