NDC 60842-021

Auvi-Q

Epinephrine

Auvi-Q is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Kaleo, Inc. The primary component is Epinephrine.

• Product ID: 60842-021_011870d0-605d-4cf0-8c7b-15f34fb609bd
• NDC: 60842-021
• Product Type: Human Prescription Drug
• Proprietary Name: Auvi-Q
• Generic Name: Epinephrine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2017-11-17
• Marketing Category: NDA / NDA
• Application Number: NDA201739
• Labeler Name: kaleo, Inc
• Substance Name: EPINEPHRINE
• Active Ingredient Strength: 0 mg/.1mL
• Pharm Classes: Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 60842-021-01

2 DOSE PACK in 1 CARTON (60842-021-01) > .1 mL in 1 DOSE PACK

• Marketing Start Date: 2017-11-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60842-021-01 [60842002101]

Auvi-Q INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA201739
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-11-17

Drug Details

Active Ingredients

Ingredient	Strength
EPINEPHRINE	.1 mg/.1mL

OpenFDA Data

• SPL SET ID: 6180fb40-7fca-4602-b3da-ce62b8cd2470
• Manufacturer:
  • kaleo, Inc
• UNII:
  • YKH834O4BH
• RxNorm Concept Unique ID - RxCUI:
  • 1870205
  • 1870232
  • 1991328
  • 1991329
  • 1305268
  • 1305269
• UPC Code:
  • 0060842024015
  • 0060842022011
  • 0060842025012

Pharmacological Class

• Adrenergic alpha-Agonists [MoA]
• Adrenergic beta-Agonists [MoA]
• alpha-Adrenergic Agonist [EPC]
• beta-Adrenergic Agonist [EPC]
• Catecholamine [EPC]
• Catecholamines [CS]

NDC Crossover Matching brand name "Auvi-Q" or generic name "Epinephrine"

NDC	Brand Name	Generic Name
60842-022	Auvi-Q	Auvi-Q
60842-021	Auvi-Q	Auvi-Q
60842-023	Auvi-Q	Auvi-Q
71872-7172	Auvi-Q	Auvi-Q
71872-7173	Auvi-Q	Auvi-Q
0220-0076	Adrenalinum	EPINEPHRINE
0220-0078	Adrenalinum	EPINEPHRINE
0093-5985	Epinephrine	Epinephrine
0093-5986	Epinephrine	Epinephrine
0115-1694	epinephrine	epinephrine
0115-1695	epinephrine	epinephrine
0404-9856	Epinephrine	Epinephrine
0404-9857	EPINEPHRINE	EPINEPHRINE
0409-4921	Epinephrine	EPINEPHRINE
0409-4933	EPINEPHRINE	epinephrine
0409-7241	EPINEPHRINE	epinephrine
0517-1130	Epinephrine	Epinephrine
0517-1171	epinephrine	epinephrine
0781-3442	SYMJEPI	Epinephrine
0781-3448	SYMJEPI	Epinephrine