Prescription drug · NDA

Auvi-Q (Epinephrine) NDC 60842-023

Epinephrine .3 mg/.3mL · Injection, Solution · Intramuscular · kaleo, Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)60842-023Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60842-0023Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
60842-023-0260842002302608420023022 DOSE PACK in 1 CARTON (60842-023-02) / .3 mL in 1 DOSE PACKMarketed from Sep 10, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Auvi-Q
Generic name (nonproprietary)
epinephrine
Active ingredients
Epinephrine — .3 mg/.3mL
Dosage form
Injection, Solution
Route
Intramuscular
Labeler
kaleo, IncNDC labeler code 60842
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 201739
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
Identifiers
Product ID 60842-023_bde1de46-464f-46b6-bda6-66ce27e21e75SPL ID bde1de46-464f-46b6-bda6-66ce27e21e75SPL set ID 6180fb40-7fca-4602-b3da-ce62b8cd2470RxCUI 1305268, 1305269, 1870205, 1870232, 1991328, 1991329UNII YKH834O4BHUPC 0360842025013
Pharmacologic class
Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeMed-Code curated

J0171 — Injection, adrenalin, epinephrine, 0.1 mg

Billing unit: 0.1 mg. Units on the claim = dose given ÷ 0.1 mg.

Applies when epinephrine is administered in a clinical setting. Auto-injectors dispensed to patients are billed by NDC through a pharmacy benefit.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N460842002302 followed by a unit qualifier and the quantity

Package 60842-0023-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

AUVI-Q is indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 7.5 kg or greater. AUVI-Q is a non-selective alpha and beta-adrenergic receptor agonist indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 7.5 kg or greater. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60842-023

What is NDC 60842-023?
60842-023 is the product NDC for Auvi-Q (epinephrine), Epinephrine .3 mg/.3mL injection, solution, listed with the FDA by kaleo, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Auvi-Q (Epinephrine).
What is the active ingredient?
Epinephrine.
Who is the labeler?
kaleo, Inc, NDC labeler code 60842. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Auvi-Q?
12 other product NDCs are listed under this name. See all Auvi-Q NDCs.
Is there a related HCPCS / J-code?
Yes: J0171, Injection, adrenalin, epinephrine, 0.1 mg. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Auvi-Q NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Auvi-QepinephrineEpinephrine .1 mg/.1mLInjection, SolutionIntramuscularkaleo, Inc60842-02160842-0021-02
Auvi-QepinephrineEpinephrine .1 mg/.1mLInjection, SolutionIntramuscularSportpharm LLC85766-27585766-0275-02
Auvi-QEpinephrine .1 mg/.1mLInjection, SolutionIntramuscularHF Acquisition Co LLC, DBA HealthFirst51662-166151662-1661-02
Auvi-QEpinephrine .15 mg/.15mLInjection, SolutionIntramuscularHF Acquisition Co LLC, DBA HealthFirst51662-166251662-1662-02
Auvi-QEpinephrine .3 mg/.3mLInjection, SolutionIntramuscularHF Acquisition Co LLC, DBA HealthFirst51662-166351662-1663-02
Auvi-QepinephrineEpinephrine .15 mg/.15mLInjection, SolutionIntramuscularkaleo, Inc60842-02260842-0022-02
Auvi-QepinephrineEpinephrine .15 mg/.15mLInjection, SolutionIntramuscularMedical Purchasing Solutions, LLC71872-717271872-7172-01
Auvi-QepinephrineEpinephrine .3 mg/.3mLInjection, SolutionIntramuscularMedical Purchasing Solutions, LLC71872-717371872-7173-01
Auvi-QepinephrineEpinephrine .3 mg/.3mLInjection, SolutionIntramuscularMedical Purchasing Solutions, LLC71872-732971872-7329-01
Auvi-QepinephrineEpinephrine .15 mg/.15mLInjection, SolutionIntramuscularMedical Purchasing Solutions, LLC71872-733371872-7333-01

All 13 Auvi-Q NDCs

Other NDCs under NDA 201739

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 201739
ProductStrengthForm · routeLabelerProduct NDC
Auvi-QEpinephrine .1 mg/.1mLInjection, SolutionIntramuscularHF Acquisition Co LLC, DBA HealthFirst51662-1661
Auvi-QEpinephrine .15 mg/.15mLInjection, SolutionIntramuscularHF Acquisition Co LLC, DBA HealthFirst51662-1662
Auvi-QEpinephrine .3 mg/.3mLInjection, SolutionIntramuscularHF Acquisition Co LLC, DBA HealthFirst51662-1663
Auvi-QepinephrineEpinephrine .1 mg/.1mLInjection, SolutionIntramuscularkaleo, Inc60842-021
Auvi-QepinephrineEpinephrine .15 mg/.15mLInjection, SolutionIntramuscularkaleo, Inc60842-022
Auvi-QepinephrineEpinephrine .15 mg/.15mLInjection, SolutionIntramuscularMedical Purchasing Solutions, LLC71872-7172
Auvi-QepinephrineEpinephrine .3 mg/.3mLInjection, SolutionIntramuscularMedical Purchasing Solutions, LLC71872-7173
Auvi-QepinephrineEpinephrine .3 mg/.3mLInjection, SolutionIntramuscularMedical Purchasing Solutions, LLC71872-7329
Auvi-QepinephrineEpinephrine .15 mg/.15mLInjection, SolutionIntramuscularMedical Purchasing Solutions, LLC71872-7333
Auvi-QepinephrineEpinephrine .1 mg/.1mLInjection, SolutionIntramuscularSportpharm LLC85766-275
Auvi-QepinephrineEpinephrine .15 mg/.15mLInjection, SolutionIntramuscularSportpharm LLC85766-276
Auvi-QepinephrineEpinephrine .3 mg/.3mLInjection, SolutionIntramuscularSportpharm LLC85766-277
EpinephrineEpinephrine .3 mg/.3mLInjection, SolutionIntramuscularHF Acquisition Co LLC, DBA HealthFirst51662-1320
EpinephrineEpinephrine .15 mg/.15mLInjection, SolutionIntramuscularHF Acquisition Co LLC, DBA HealthFirst51662-1321
EpinephrineEpinephrine .1 mg/.1mLInjection, SolutionIntramuscularHF Acquisition Co LLC, DBA HealthFirst51662-1476

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