FDA.reportPublic FDA data

Auvi-Q

Product NDC
60842-021
11-digit product format
608420021
Labeler code
60842
Product ID
60842-021_bde1de46-464f-46b6-bda6-66ce27e21e75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
kaleo, Inc
Application
NDA201739
Marketing category
NDA
Marketing start
2017-11-17
Substance
EPINEPHRINE
Active strength
.1 mg/.1mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Auvi-Q
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE.1 mg/.1mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui1305268, 1305269, 1870205, 1870232, 1991328, 1991329

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60842-021-01Auvi-Q2 in 1 CARTONINJECTION, SOLUTION221
60842-021-01Auvi-Q0.1 mL in 1 DOSE PACKINJECTION, SOLUTION0.121
60842-021-02Auvi-Q0.1 mL in 1 DOSE PACKINJECTION, SOLUTION0.121
60842-021-02Auvi-Q2 in 1 CARTONINJECTION, SOLUTION221

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60842-021AUVI-Q (EPINEPHRINE) INJECTION, SOLUTION [KALEO, INC]20Current NDC, Legacy NDC, 4 package rows20250515_6180fb40-7fca-4602-b3da-ce62b8cd2470.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1991329Auvi-Q 0.1 MG in 0.1 ML Auto-InjectorPSN6180fb40-7fca-4602-b3da-ce62b8cd247021
1305268Auvi-Q 0.15 MG in 0.15 ML Auto-InjectorPSN6180fb40-7fca-4602-b3da-ce62b8cd247021
1305269Auvi-Q 0.3 MG in 0.3 ML Auto-InjectorPSN6180fb40-7fca-4602-b3da-ce62b8cd247021
1991328EPINEPHrine (generic for Auvi-Q) 0.1 MG in 0.1 ML Auto-InjectorPSN6180fb40-7fca-4602-b3da-ce62b8cd247021
1870232EPINEPHrine (generic for Auvi-Q) 0.15 MG in 0.15 ML Auto-InjectorPSN6180fb40-7fca-4602-b3da-ce62b8cd247021
1870205EPINEPHrine (generic for Auvi-Q) 0.3 MG in 0.3 ML Auto-InjectorPSN6180fb40-7fca-4602-b3da-ce62b8cd247021
1991329NDA201739 0.1 ML epinephrine 1 MG/ML Auto-Injector [Auvi-Q]SBD6180fb40-7fca-4602-b3da-ce62b8cd247021
1305268NDA201739 0.15 ML epinephrine 1 MG/ML Auto-Injector [Auvi-Q]SBD6180fb40-7fca-4602-b3da-ce62b8cd247021
1305269NDA201739 0.3 ML epinephrine 1 MG/ML Auto-Injector [Auvi-Q]SBD6180fb40-7fca-4602-b3da-ce62b8cd247021
1991328NDA201739 0.1 ML epinephrine 1 MG/ML Auto-InjectorSCD6180fb40-7fca-4602-b3da-ce62b8cd247021
1870232NDA201739 0.15 ML epinephrine 1 MG/ML Auto-InjectorSCD6180fb40-7fca-4602-b3da-ce62b8cd247021
1870205NDA201739 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD6180fb40-7fca-4602-b3da-ce62b8cd247021
13052690.3 ML Auvi-Q 1 MG/ML Auto-InjectorSY6180fb40-7fca-4602-b3da-ce62b8cd247021
1991329Auvi-Q 0.1 MG per 0.1 ML Auto-InjectorSY6180fb40-7fca-4602-b3da-ce62b8cd247021
1305268Auvi-Q 0.15 MG per 0.15 ML Auto-InjectorSY6180fb40-7fca-4602-b3da-ce62b8cd247021
1305269Auvi-Q 0.3 MG per 0.3 ML Auto-InjectorSY6180fb40-7fca-4602-b3da-ce62b8cd247021
1991328epinephrine (generic for Auvi-Q) 0.1 MG per 0.1 ML Auto-InjectorSY6180fb40-7fca-4602-b3da-ce62b8cd247021
1870232epinephrine (generic for Auvi-Q) 0.15 MG per 0.15 ML Auto-InjectorSY6180fb40-7fca-4602-b3da-ce62b8cd247021
1870205epinephrine (generic for Auvi-Q) 0.3 MG per 0.3 ML Auto-InjectorSY6180fb40-7fca-4602-b3da-ce62b8cd247021
1991329NDA201739 0.1 ML Auvi-Q 1 MG/ML Auto-InjectorSY6180fb40-7fca-4602-b3da-ce62b8cd247021
1305268NDA201739 0.15 ML Auvi-Q 1 MG/ML Auto-InjectorSY6180fb40-7fca-4602-b3da-ce62b8cd247021
1305269NDA201739 0.3 ML Auvi-Q 1 MG/ML Auto-InjectorSY6180fb40-7fca-4602-b3da-ce62b8cd247021
1991328EPINEPHrine (generic for Auvi-Q) 0.1 MG in 0.1 ML Auto-InjectorPSN98aaa648-fc25-754d-e053-2995a90a70515
1991328NDA201739 0.1 ML epinephrine 1 MG/ML Auto-InjectorSCD98aaa648-fc25-754d-e053-2995a90a70515
1991328epinephrine (generic for Auvi-Q) 0.1 MG per 0.1 ML Auto-InjectorSY98aaa648-fc25-754d-e053-2995a90a70515
1991328EPINEPHrine (generic for Auvi-Q) 0.1 MG in 0.1 ML Auto-InjectorPSN23e772f8-26d0-b516-e063-6394a90ada582
1991328NDA201739 0.1 ML epinephrine 1 MG/ML Auto-InjectorSCD23e772f8-26d0-b516-e063-6394a90ada582
1991328epinephrine (generic for Auvi-Q) 0.1 MG per 0.1 ML Auto-InjectorSY23e772f8-26d0-b516-e063-6394a90ada582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60842-021-01608420021012 DOSE PACK in 1 CARTON (60842-021-01) > .1 mL in 1 DOSE PACK2 dose pack2017-11-170000-00-00NoNoCurrent
60842-021-02608420021022 DOSE PACK in 1 CARTON (60842-021-02) / .1 mL in 1 DOSE PACK2 dose pack2024-09-05NoNoCurrent