Auvi-Q

Product NDC: 60842-023
11-digit product format: 608420023
Labeler code: 60842
Product ID: 60842-023_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: 2012-11-15
Substance: EPINEPHRINE
Active strength: .3 mg/.3mL
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60842-023	60842-023-01	D	Discontinued by firm		2026-08-10

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N201739-001	AUVI-Q	EPINEPHRINE	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10
N201739-002	AUVI-Q	EPINEPHRINE	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10
N201739-003	AUVI-Q	EPINEPHRINE	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N201739-001	BX
N201739-002	BX

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201739-001	11590286	2026-12-12		Drug product	2023-03-29
N201739-001	8206360	2027-02-27		Drug product	2013-03-21
N201739-001	7947017	2028-03-12		Drug product	2013-02-22
N201739-001	8231573	2028-11-25		Drug product	2012-08-21
N201739-001	8226610	2029-04-10		Drug product	2012-08-21
N201739-001	8021344	2029-11-02		Drug product	2013-07-26
N201739-002	11590286	2026-12-12		Drug product	2023-03-29
N201739-002	8206360	2027-02-27		Drug product
N201739-002	7947017	2028-03-12		Drug product
N201739-002	8231573	2028-11-25		Drug product
N201739-002	8226610	2029-04-10		Drug product
N201739-002	8021344	2029-11-02		Drug product	2013-07-26
N201739-002	10688244	2037-12-21	U-2980	Drug product	2020-11-04
N201739-002	10842938	2037-12-21	U-2980	Drug product	2020-12-10
N201739-002	11771830	2037-12-21	U-2980	Drug product	2023-12-20
N201739-003	11590286	2026-12-12		Drug product	2023-03-29
N201739-003	8206360	2027-02-27		Drug product	2017-12-15
N201739-003	7947017	2028-03-12		Drug product	2017-12-15
N201739-003	8231573	2028-11-25		Drug product	2017-12-15
N201739-003	8226610	2029-04-10		Drug product	2017-12-15
N201739-003	8021344	2029-11-02		Drug product	2017-12-15
N201739-003	10688244	2037-12-21	U-2980	Drug product	2020-11-04
N201739-003	10842938	2037-12-21	U-2980	Drug product	2020-12-10
N201739-003	11771830	2037-12-21	U-2980	Drug product	2023-12-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201739-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201739-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201739-002	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201739-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201739-002	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201739-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201739-002	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201739-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201739-002	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201739-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201739-002	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201739-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201739-002	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201739-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201739-002	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201739-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201739-002	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201739-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201739-002	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201739-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201739-002	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201739-001	BX	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201739-002	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201739-001	BX	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N201739-002	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201739-001	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201739-002	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201739-001	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201739-002	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201739-001	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201739-002	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201739-001	BX	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201739-002	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201739-001	BX	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201739-002	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201739-001	BX	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201739-002	BX	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 69 · 2,725 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201739-001	11590286	2026-12-12		Drug product	2023-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-001	8206360	2027-02-27		Drug product	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-001	7947017	2028-03-12		Drug product	2013-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-001	8231573	2028-11-25		Drug product	2012-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-001	8226610	2029-04-10		Drug product	2012-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-001	8021344	2029-11-02		Drug product	2013-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	11590286	2026-12-12		Drug product	2023-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	8206360	2027-02-27		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	7947017	2028-03-12		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	8231573	2028-11-25		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	8226610	2029-04-10		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	8021344	2029-11-02		Drug product	2013-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	10688244	2037-12-21	U-2980	Drug product	2020-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	10842938	2037-12-21	U-2980	Drug product	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	11771830	2037-12-21	U-2980	Drug product	2023-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	11590286	2026-12-12		Drug product	2023-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	8206360	2027-02-27		Drug product	2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	7947017	2028-03-12		Drug product	2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	8231573	2028-11-25		Drug product	2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	8226610	2029-04-10		Drug product	2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	8021344	2029-11-02		Drug product	2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	10688244	2037-12-21	U-2980	Drug product	2020-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	10842938	2037-12-21	U-2980	Drug product	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	11771830	2037-12-21	U-2980	Drug product	2023-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	10335549	2025-04-30		Drug product	2019-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	11590286	2026-12-12		Drug product	2023-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	8206360	2027-02-27		Drug product	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	7947017	2028-03-12		Drug product	2013-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	8231573	2028-11-25		Drug product	2012-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	8226610	2029-04-10		Drug product	2012-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	8021344	2029-11-02		Drug product	2013-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	10335549	2025-04-30		Drug product	2019-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	11590286	2026-12-12		Drug product	2023-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	8206360	2027-02-27		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	7947017	2028-03-12		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	8231573	2028-11-25		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	8226610	2029-04-10		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	8021344	2029-11-02		Drug product	2013-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	10688244	2037-12-21	U-2980	Drug product	2020-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	10842938	2037-12-21	U-2980	Drug product	2020-12-10	`31067a03dcf5…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EPINEPHRINE	.3 mg/.3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YKH834O4BH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1305268	Internal RxNorm lookup
1305269	Internal RxNorm lookup
1870205	Internal RxNorm lookup
1870232	Internal RxNorm lookup
1991328	Internal RxNorm lookup
1991329	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6180fb40-7fca-4602-b3da-ce62b8cd2470	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0b4ec9ca-d305-43fc-88dd-7a510313efe0	Product name	1	20260105
bb209f42-a85f-4fee-9d3d-c9dded168625	Product name	1	20251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3	Product name	3	20251118
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
b5b1095b-40cd-8a9e-b111-502545045b07	Product name	4	20250325
e190029e-423b-473c-8e04-2ada59b5b711	Product name	1	20250314
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42	Product name	1	20180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60842-023-01	Auvi-Q	2 in 1 CARTON	INJECTION, SOLUTION	2	21
60842-023-01	Auvi-Q	0.3 mL in 1 DOSE PACK	INJECTION, SOLUTION	0.3	21
60842-023-02	Auvi-Q	2 in 1 CARTON	INJECTION, SOLUTION	2	21
60842-023-02	Auvi-Q	0.3 mL in 1 DOSE PACK	INJECTION, SOLUTION	0.3	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60842-023-01	EA - Each	60842-023	5e6085fd-57e1-4e36-aaf4-222dea62213f	1	2017-03-06
60842-023-02	EA - Each	60842-023	02bb7bb1-a347-416a-a90b-ae7151b2057d	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60842-023	AUVI-Q (EPINEPHRINE) INJECTION, SOLUTION [KALEO, INC]	20	Current NDC, Legacy NDC, 4 package rows	20250515_6180fb40-7fca-4602-b3da-ce62b8cd2470.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Auvi-Q	EPINEPHRINE	kaleo, Inc	6180fb40-7fca-4602-b3da-ce62b8cd2470	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739 ndc (product): 60842-023
AUVI-Q	AUVI-Q	HF Acquisition Co LLC, DBA HealthFirst	23e772f8-26d0-b516-e063-6394a90ada58	2025-05-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739
Auvi-Q	EPINEPHRINE	Medical Purchasing Solutions, LLC	296a9023-b5c6-6102-e063-6294a90af87e	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739
Auvi-Q	EPINEPHRINE	Medical Purchasing Solutions, LLC	29299266-69c5-b1a7-e063-6394a90a25f8	2024-12-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739
AUVI-Q	AUVI-Q	HF Acquisition Co LLC, DBA HealthFirst	23fd4c93-0a42-922e-e063-6394a90a1887	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739
AUVI-Q	AUVI-Q	HF Acquisition Co LLC, DBA HealthFirst	23fdb616-0c60-44fe-e063-6394a90ad8f1	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	98aaa648-fc25-754d-e053-2995a90a7051	2024-03-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	7664bb0d-dc1a-ca8b-e053-2991aa0ad627	2024-02-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739
Auvi-Q	EPINEPHRINE	Medical Purchasing Solutions, LLC	8f110633-bf37-458d-e053-2a95a90a8fa9	2023-04-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739
Auvi-Q	EPINEPHRINE	Medical Purchasing Solutions, LLC	8f00231e-be88-49fe-e053-2a95a90ab6dd	2023-04-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YKH834O4BH	EPINEPHRINE	51-43-4	EPINEPHRINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1991329	Auvi-Q 0.1 MG in 0.1 ML Auto-Injector	PSN	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1305268	Auvi-Q 0.15 MG in 0.15 ML Auto-Injector	PSN	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1305269	Auvi-Q 0.3 MG in 0.3 ML Auto-Injector	PSN	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1991328	EPINEPHrine (generic for Auvi-Q) 0.1 MG in 0.1 ML Auto-Injector	PSN	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1870232	EPINEPHrine (generic for Auvi-Q) 0.15 MG in 0.15 ML Auto-Injector	PSN	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1870205	EPINEPHrine (generic for Auvi-Q) 0.3 MG in 0.3 ML Auto-Injector	PSN	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1991329	NDA201739 0.1 ML epinephrine 1 MG/ML Auto-Injector [Auvi-Q]	SBD	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1305268	NDA201739 0.15 ML epinephrine 1 MG/ML Auto-Injector [Auvi-Q]	SBD	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1305269	NDA201739 0.3 ML epinephrine 1 MG/ML Auto-Injector [Auvi-Q]	SBD	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1991328	NDA201739 0.1 ML epinephrine 1 MG/ML Auto-Injector	SCD	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1870232	NDA201739 0.15 ML epinephrine 1 MG/ML Auto-Injector	SCD	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1870205	NDA201739 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1305269	0.3 ML Auvi-Q 1 MG/ML Auto-Injector	SY	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1991329	Auvi-Q 0.1 MG per 0.1 ML Auto-Injector	SY	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1305268	Auvi-Q 0.15 MG per 0.15 ML Auto-Injector	SY	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1305269	Auvi-Q 0.3 MG per 0.3 ML Auto-Injector	SY	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1991328	epinephrine (generic for Auvi-Q) 0.1 MG per 0.1 ML Auto-Injector	SY	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1870232	epinephrine (generic for Auvi-Q) 0.15 MG per 0.15 ML Auto-Injector	SY	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1870205	epinephrine (generic for Auvi-Q) 0.3 MG per 0.3 ML Auto-Injector	SY	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1991329	NDA201739 0.1 ML Auvi-Q 1 MG/ML Auto-Injector	SY	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1305268	NDA201739 0.15 ML Auvi-Q 1 MG/ML Auto-Injector	SY	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1305269	NDA201739 0.3 ML Auvi-Q 1 MG/ML Auto-Injector	SY	6180fb40-7fca-4602-b3da-ce62b8cd2470	21
1870232	EPINEPHrine (generic for Auvi-Q) 0.15 MG in 0.15 ML Auto-Injector	PSN	7664bb0d-dc1a-ca8b-e053-2991aa0ad627	10
1870205	EPINEPHrine (generic for Auvi-Q) 0.3 MG in 0.3 ML Auto-Injector	PSN	7664bb0d-dc1a-ca8b-e053-2991aa0ad627	10
1870232	NDA201739 0.15 ML epinephrine 1 MG/ML Auto-Injector	SCD	7664bb0d-dc1a-ca8b-e053-2991aa0ad627	10
1870205	NDA201739 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	7664bb0d-dc1a-ca8b-e053-2991aa0ad627	10
1870232	epinephrine (generic for Auvi-Q) 0.15 MG per 0.15 ML Auto-Injector	SY	7664bb0d-dc1a-ca8b-e053-2991aa0ad627	10
1870205	epinephrine (generic for Auvi-Q) 0.3 MG per 0.3 ML Auto-Injector	SY	7664bb0d-dc1a-ca8b-e053-2991aa0ad627	10
1305269	Auvi-Q 0.3 MG in 0.3 ML Auto-Injector	PSN	8f110633-bf37-458d-e053-2a95a90a8fa9	4
1870205	EPINEPHrine (generic for Auvi-Q) 0.3 MG in 0.3 ML Auto-Injector	PSN	8f110633-bf37-458d-e053-2a95a90a8fa9	4
1305269	NDA201739 0.3 ML epinephrine 1 MG/ML Auto-Injector [Auvi-Q]	SBD	8f110633-bf37-458d-e053-2a95a90a8fa9	4
1870205	NDA201739 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	8f110633-bf37-458d-e053-2a95a90a8fa9	4
1305269	0.3 ML Auvi-Q 1 MG/ML Auto-Injector	SY	8f110633-bf37-458d-e053-2a95a90a8fa9	4
1305269	Auvi-Q 0.3 MG per 0.3 ML Auto-Injector	SY	8f110633-bf37-458d-e053-2a95a90a8fa9	4
1870205	epinephrine (generic for Auvi-Q) 0.3 MG per 0.3 ML Auto-Injector	SY	8f110633-bf37-458d-e053-2a95a90a8fa9	4
1305269	NDA201739 0.3 ML Auvi-Q 1 MG/ML Auto-Injector	SY	8f110633-bf37-458d-e053-2a95a90a8fa9	4
1305269	Auvi-Q 0.3 MG in 0.3 ML Auto-Injector	PSN	29299266-69c5-b1a7-e063-6394a90a25f8	1
1870205	EPINEPHrine (generic for Auvi-Q) 0.3 MG in 0.3 ML Auto-Injector	PSN	29299266-69c5-b1a7-e063-6394a90a25f8	1
1870205	EPINEPHrine (generic for Auvi-Q) 0.3 MG in 0.3 ML Auto-Injector	PSN	23fdb616-0c60-44fe-e063-6394a90ad8f1	1
1305269	NDA201739 0.3 ML epinephrine 1 MG/ML Auto-Injector [Auvi-Q]	SBD	29299266-69c5-b1a7-e063-6394a90a25f8	1
1870205	NDA201739 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	29299266-69c5-b1a7-e063-6394a90a25f8	1
1870205	NDA201739 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	23fdb616-0c60-44fe-e063-6394a90ad8f1	1
1305269	0.3 ML Auvi-Q 1 MG/ML Auto-Injector	SY	29299266-69c5-b1a7-e063-6394a90a25f8	1
1305269	Auvi-Q 0.3 MG per 0.3 ML Auto-Injector	SY	29299266-69c5-b1a7-e063-6394a90a25f8	1
1870205	epinephrine (generic for Auvi-Q) 0.3 MG per 0.3 ML Auto-Injector	SY	29299266-69c5-b1a7-e063-6394a90a25f8	1
1870205	epinephrine (generic for Auvi-Q) 0.3 MG per 0.3 ML Auto-Injector	SY	23fdb616-0c60-44fe-e063-6394a90ad8f1	1
1305269	NDA201739 0.3 ML Auvi-Q 1 MG/ML Auto-Injector	SY	29299266-69c5-b1a7-e063-6394a90a25f8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60842-023-01	60842002301	2 DOSE PACK in 1 CARTON (60842-023-01) > .3 mL in 1 DOSE PACK	2 dose pack	2012-11-15	0000-00-00	No	No	Current
60842-023-02	60842002302	2 DOSE PACK in 1 CARTON (60842-023-02) / .3 mL in 1 DOSE PACK	2 dose pack	2024-09-10		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Auvi-Q	kaleo, Inc	2025-10-02	HUMAN PRESCRIPTION DRUG LABEL	21
Auvi-Q	Medical Purchasing Solutions, LLC	2024-12-13	HUMAN PRESCRIPTION DRUG LABEL	1
AUVI-Q - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2024-10-08	HUMAN PRESCRIPTION DRUG LABEL	1
AUVI-Q(R) EPINEPHRINE INJECTION, AUTO INJECTOR	HF Acquisition Co LLC, DBA HealthFirst	2024-02-19	HUMAN PRESCRIPTION DRUG LABEL	10
Auvi-Q	Medical Purchasing Solutions, LLC	2023-04-26	HUMAN PRESCRIPTION DRUG LABEL	4