Auvi-q Injection, Solution
NDC Package 51662-1663-2

11-digit billing NDC: 51662166302
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Auvi-q injection is aUVI-Q® is 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, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.AUVI-Q is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.Anaphylactic 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.AUVI-Q is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical care. This formulation utilizes a injection, solution delivery system. Marketed by Hf Acquisition Co Llc, Dba Healthfirst, this product is identified by NDC 51662-1663 and is authorized under FDA application NDA201739.

Identification & Billing

NDC Package Code
51662-1663-2
Package Description
2 DOSE PACK in 1 CARTON / .3 mL in 1 DOSE PACK (51662-1663-1)
Product Code
51662-1663
11-Digit Billing Format
51662166302
RxNorm Crosswalk
  • RxCUI: 1870205 - EPINEPHrine (generic for Auvi-Q) 0.3 MG in 0.3 ML Auto-Injector
  • RxCUI: 1870205 - NDA201739 0.3 ML epinephrine 1 MG/ML Auto-Injector
  • RxCUI: 1870205 - epinephrine (generic for Auvi-Q) 0.3 MG per 0.3 ML Auto-Injector

Clinical Specifications

Proprietary Name
Auvi-q
Non-Proprietary Name
Auvi-q
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 .3 mg/.3mL
Pharmacologic Class
Usage Information
AUVI-Q® is 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, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.AUVI-Q is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.Anaphylactic 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.AUVI-Q is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical care.

Regulatory & Marketing

Labeler Name
Hf Acquisition Co Llc, Dba Healthfirst
Product Type
Human Prescription Drug
FDA Application #
NDA201739
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-15-2012
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51662-1663-2 identifies a specific commercial package of 2 dose pack in 1 carton / .3 ml in 1 dose pack (51662-1663-1) of Auvi-q, a human prescription drug labeled by Hf Acquisition Co Llc, Dba Healthfirst. 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 Hf Acquisition Co Llc, Dba Healthfirst on November 15, 2012. The current certification is valid through December 31, 2026.

How is this Hf Acquisition Co Llc, Dba Healthfirst product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51662166302. 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)
51662-1663-2
11-Digit CMS (5-4-2)
51662-1663-02

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