Epinephrine 0.3 Adults Injection
NDC Package 70385-2019-1

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

Package Information

Epinephrine 0.3 Adults injection is a medication used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. This formulation utilizes a injection delivery system. Marketed by Sina Health Inc, this product is identified by NDC 70385-2019 and is authorized under FDA application NDA019430.

Identification & Billing

NDC Package Code
70385-2019-1
Package Description
1 CONTAINER in 1 PACKAGE / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS
Product Code
70385-2019
11-Digit Billing Format
70385201901
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

Clinical Specifications

Proprietary Name
Epinephrine 0.3 Adults
Non-Proprietary Name
Epinephrine 0.3 Adults
Substance Name
Epinephrine
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)
EPINEPHRINE .3 mg/.3mL
Pharmacologic Class
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
Sina Health Inc
Product Type
Human Prescription Drug
FDA Application #
NDA019430
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
12-15-2016
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 70385-2019-1 identifies a specific commercial package of 1 container in 1 package / 1 syringe, glass in 1 container / .3 ml in 1 syringe, glass of Epinephrine 0.3 Adults, a human prescription drug labeled by Sina Health Inc. This injection is formulated for intramuscular use and contains epinephrine 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 Sina Health Inc on December 15, 2016. The current certification is valid through December 31, 2027.

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 Sina Health Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70385201901. 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)
70385-2019-1
11-Digit CMS (5-4-2)
70385-2019-01

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