Epinephrine
NDC Package 0548-2016-00

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Epinephrine is a medication used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Marketed by Amphastar Pharmaceuticals, Inc., this product is identified by NDC 0548-2016.

Identification & Billing

NDC Package Code
0548-2016-00
Package Description
25 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE
Product Code
0548-2016
11-Digit Billing Format
00548201600

Clinical Specifications

Proprietary Name
Epinephrine
Dosage Form
-
Usage Information
This medication is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Epinephrine acts quickly to improve breathing, stimulate the heart, raise a dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.

Regulatory & Marketing

Labeler Name
Amphastar Pharmaceuticals, Inc.
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
01-02-1990
End Marketing Date
09-02-2010
Listing Expiration
09-02-2010
Exclude Flag
D
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 0548-2016-00 identifies a specific commercial package of 25 syringe in 1 carton / 10 ml in 1 syringe of Epinephrine, labeled by Amphastar Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Amphastar Pharmaceuticals, Inc. on January 02, 1990. The current certification is valid through September 02, 2010.

What are the primary indications for this medication?

This medication is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Epinephrine acts quickly to improve breathing, stimulate the heart, raise a dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.

How is this Amphastar Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00548201600. 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)
0548-2016-00
11-Digit CMS (5-4-2)
00548-2016-00

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