Epipen Jr
NDC Package 54868-4819-0

11-digit billing NDC: 54868481900 · Billing unit: EA · 2 EA per package
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 inactivated by the FDA.

Epipen Jr is epiPen® and EpiPen® Jr Auto-Injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitos), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4819 and is authorized under FDA application NDA019430.

Identification & Billing

NDC Package Code
54868-4819-0
Package Description
2 CONTAINER in 1 CARTON / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS
Product Code
54868-4819
11-Digit Billing Format
54868481900
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk
  • RxCUI: 1870207 - EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-Injector
  • RxCUI: 1870207 - NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector
  • RxCUI: 1870207 - epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-Injector
  • RxCUI: 727316 - EPINEPHrine (generic for EpiPen Jr) 0.15 MG in 0.3 ML Auto-Injector
  • RxCUI: 727316 - NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-Injector

Clinical Specifications

Proprietary Name
Epipen Jr
Dosage Form
-
Usage Information
EpiPen® and EpiPen® Jr Auto-Injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitos), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen® and EpiPen® Jr Auto-Injectors are intended for immediate administration in patients, who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to patient body weight (see DOSAGE AND ADMINISTRATION section). Such reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen® and EpiPen® Jr Auto-Injectors are intended for immediate self-administration as emergency supportive therapy only and are not a substitute for immediate medical care.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA019430
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-17-2003
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-4819-0 identifies a specific commercial package of 2 container in 1 carton / 1 syringe, glass in 1 container / .3 ml in 1 syringe, glass of Epipen Jr, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. 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 Physicians Total Care, Inc. on June 17, 2003. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868481900. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 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 (5-4-1)
54868-4819-0
11-Digit CMS (5-4-2)
54868-4819-00

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