Auvi-q Injection, Solution
NDC Package 60842-021-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Auvi-q (epinephrine) 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, solution delivery system. Marketed by Kaleo, Inc, this product is identified by NDC 60842-021 and is authorized under FDA application NDA201739.

Identification & Billing

NDC Package Code
60842-021-01
Package Description
2 DOSE PACK in 1 CARTON / .1 mL in 1 DOSE PACK
Product Code
60842-021
11-Digit Billing Format
60842002101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Auvi-q
Non-Proprietary Name
Epinephrine
Substance Name
Epinephrine
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
Intramuscular - Administration within a muscle.
Active Ingredient(s)
EPINEPHRINE .1 mg/.1mL
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
Kaleo, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA201739
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-17-2017
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0165
Source: PDAC
INJECTION, EPINEPHRINE, NOT OTHERWISE SPECIFIED, 0.1 MG
HCPCS Dosage 0.1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (60842-021). Click a package code to view its specific billing and regulatory data.

60842-021-02
2 DOSE PACK in 1 CARTON / .1 mL in 1 DOSE PACK

* 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 60842-021-01 identifies a specific commercial package of 2 dose pack in 1 carton / .1 ml in 1 dose pack of Auvi-q, a human prescription drug labeled by Kaleo, Inc. This injection, solution 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 Kaleo, Inc on November 17, 2017. The current certification is valid through December 31, 2026.

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 Kaleo, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60842002101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
60842-021-01
11-Digit CMS (5-4-2)
60842-0021-01

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