Adrenalin

Product NDC: 42023-168
11-digit product format: 420230168
Labeler code: 42023
Product ID: 42023-168_1fbe8c4a-ff3c-48b6-b42f-19c948510266
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: epinephrine
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Par Health USA, LLC
Application: NDA204640
Marketing category: NDA
Marketing start: 2020-12-04
Substance: EPINEPHRINE
Active strength: 1 mg/mL
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: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204640-001	ADRENALIN	EPINEPHRINE	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204640-001	AP

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204640-001	10130592	2035-03-13		Drug product	2018-11-26
N204640-001	12280024	2035-03-13		Drug product	2025-04-25
N204640-001	9119876	2035-03-13		Drug product	2015-09-01
N204640-001	9295657	2035-03-13	U-1829		2016-04-12

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 2 · 41 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	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2013-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2013-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2013-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2013-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204640-001	ADRENALIN	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2013-12-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204640-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204640-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204640-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204640-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204640-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204640-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204640-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204640-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204640-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204640-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204640-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204640-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204640-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204640-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204640-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204640-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204640-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204640-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204640-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204640-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204640-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204640-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204640-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204640-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204640-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204640-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204640-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204640-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204640-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204640-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204640-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204640-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204640-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204640-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204640-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204640-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204640-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 127 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	N204640-001	10130592	2035-03-13		Drug product	2018-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204640-001	12280024	2035-03-13		Drug product	2025-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204640-001	9119876	2035-03-13		Drug product	2015-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204640-001	9295657	2035-03-13	U-1829		2016-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204640-001	10130592	2035-03-13		Drug product	2018-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204640-001	12280024	2035-03-13		Drug product	2025-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204640-001	9119876	2035-03-13		Drug product	2015-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204640-001	9295657	2035-03-13	U-1829		2016-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204640-001	10130592	2035-03-13		Drug product	2018-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204640-001	12280024	2035-03-13		Drug product	2025-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204640-001	9119876	2035-03-13		Drug product	2015-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204640-001	9295657	2035-03-13	U-1829		2016-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204640-001	10130592	2035-03-13		Drug product	2018-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204640-001	9119876	2035-03-13		Drug product	2015-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204640-001	9295657	2035-03-13	U-1829		2016-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204640-001	10130592	2035-03-13		Drug product	2018-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204640-001	9119876	2035-03-13		Drug product	2015-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204640-001	9295657	2035-03-13	U-1829		2016-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204640-001	10130592	2035-03-13		Drug product	2018-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204640-001	9119876	2035-03-13		Drug product	2015-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204640-001	9295657	2035-03-13	U-1829		2016-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204640-001	10130592	2035-03-13		Drug product	2018-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204640-001	9119876	2035-03-13		Drug product	2015-09-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204640-001	9295657	2035-03-13	U-1829		2016-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204640-001	10130592	2035-03-13		Drug product	2018-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204640-001	9119876	2035-03-13		Drug product	2015-09-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204640-001	9295657	2035-03-13	U-1829		2016-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204640-001	10130592	2035-03-13		Drug product	2018-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204640-001	9119876	2035-03-13		Drug product	2015-09-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204640-001	9295657	2035-03-13	U-1829		2016-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204640-001	10130592	2035-03-13		Drug product	2018-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204640-001	9119876	2035-03-13		Drug product	2015-09-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204640-001	9295657	2035-03-13	U-1829		2016-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204640-001	10130592	2035-03-13		Drug product	2018-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204640-001	9119876	2035-03-13		Drug product	2015-09-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204640-001	9295657	2035-03-13	U-1829		2016-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204640-001	10130592	2035-03-13		Drug product	2018-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204640-001	9119876	2035-03-13		Drug product	2015-09-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204640-001	9295657	2035-03-13	U-1829		2016-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204640-001	10130592	2035-03-13		Drug product	2018-11-26	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Adrenalin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EPINEPHRINE	1 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310132	Internal RxNorm lookup
1490057	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
a5ce0c01-dd47-4997-ab09-490de65d3835	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
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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
42023-168-01	Adrenalin	30 mL in 1 VIAL	INJECTION	30	20
42023-168-01	Adrenalin	1 in 1 CARTON	INJECTION	1	20
42023-168-99	Adrenalin	30 mL in 1 VIAL	INJECTION	30	11
42023-168-99	Adrenalin	1 in 1 CARTON	INJECTION	1	11
42023-168-89	Adrenalin	30 mL in 1 VIAL	INJECTION	30	10
42023-168-89	Adrenalin	1 in 1 CARTON	INJECTION	1	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42023-168-01	ML - Milliliter	42023-168	2d49fdf1-d040-40f4-80b1-10d8e384af80	1	2014-05-02
42023-168-99	ML - Milliliter	42023-168	972cb46c-cb02-4b85-b913-5800df39d3c2	1	2021-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
epinephrine	ACTIVE INGREDIENT	YKH834O4BH	ADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]	3
epinephrine	ACTIVE MOIETY	YKH834O4BH	ADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]	3
chlorobutanol	INACTIVE INGREDIENT	HM4YQM8WRC	ADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]	3
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	ADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]	3
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	ADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]	3
sodium metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	ADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]	3
water	INACTIVE INGREDIENT	059QF0KO0R	ADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42023-168	ADRENALIN (EPINEPHRINE) INJECTION [ENDO USA, INC.]	19	Current NDC, Legacy NDC, 2 package rows	20240425_3b7a4364-668d-4eb2-a20c-04adc35aabe4.zip
42023-168	ADRENALIN (EPINEPHRINE) INJECTION [ENDO USA, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20241018_b27e06aa-5b40-44bc-8de7-80b027580a3b.zip
42023-168	ADRENALIN (EPINEPHRINE) INJECTION [ENDO USA, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20241018_a5ce0c01-dd47-4997-ab09-490de65d3835.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adrenalin	EPINEPHRINE	Par Health USA, LLC	3b7a4364-668d-4eb2-a20c-04adc35aabe4	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204640 application number: NDA204640 ndc (product): 42023-168
Adrenalin	EPINEPHRINE	Par Health USA, LLC	a5ce0c01-dd47-4997-ab09-490de65d3835	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204640 application number: NDA204640 ndc (product): 42023-168
Adrenalin	EPINEPHRINE	Par Health USA, LLC	b27e06aa-5b40-44bc-8de7-80b027580a3b	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204640 application number: NDA204640 ndc (product): 42023-168
ADRENALIN(R)	ADRENALIN(R)	HF Acquisition Co LLC, DBA HealthFirst	76462d55-5448-0fd0-e053-2991aa0aa49f	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204640 application number: NDA204640

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
1660016	Adrenalin 1 MG in 1 ML Injection	PSN	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
1490057	Adrenalin 1 MG/ML Injectable Solution	PSN	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
1660014	EPINEPHrine 1 MG in 1 ML Injection	PSN	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
310132	EPINEPHrine 1 MG/ML (1:1000) Injectable Solution	PSN	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
1660016	1 ML epinephrine 1 MG/ML Injection [Adrenalin]	SBD	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
1490057	epinephrine 1 MG/ML Injectable Solution [Adrenalin]	SBD	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
1660014	1 ML epinephrine 1 MG/ML Injection	SCD	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
310132	epinephrine 1 MG/ML Injectable Solution	SCD	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
1660016	1 ML Adrenalin 1 MG/ML Injection	SY	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
1660016	Adrenalin 1 MG per 1 ML Injection	SY	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
1490057	Adrenalin 1 MG/ML Injectable Solution	SY	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
1490057	Adrenalin 1:1000 Injectable Solution	SY	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
1490057	Adrenalin 30 MG per 30 ML Injectable Solution	SY	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
310132	epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable Solution	SY	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
1660014	epinephrine 1 MG per 1 ML Injection	SY	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
310132	epinephrine 1:1000 Injectable Solution	SY	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
310132	epinephrine 500 MCG per 0.5 ML Injectable Solution	SY	3b7a4364-668d-4eb2-a20c-04adc35aabe4	20
1490057	Adrenalin 1 MG/ML Injectable Solution	PSN	b27e06aa-5b40-44bc-8de7-80b027580a3b	11
310132	EPINEPHrine 1 MG/ML (1:1000) Injectable Solution	PSN	b27e06aa-5b40-44bc-8de7-80b027580a3b	11
1490057	epinephrine 1 MG/ML Injectable Solution [Adrenalin]	SBD	b27e06aa-5b40-44bc-8de7-80b027580a3b	11
310132	epinephrine 1 MG/ML Injectable Solution	SCD	b27e06aa-5b40-44bc-8de7-80b027580a3b	11
1490057	Adrenalin 1 MG/ML Injectable Solution	SY	b27e06aa-5b40-44bc-8de7-80b027580a3b	11
1490057	Adrenalin 1:1000 Injectable Solution	SY	b27e06aa-5b40-44bc-8de7-80b027580a3b	11
1490057	Adrenalin 30 MG per 30 ML Injectable Solution	SY	b27e06aa-5b40-44bc-8de7-80b027580a3b	11
310132	epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable Solution	SY	b27e06aa-5b40-44bc-8de7-80b027580a3b	11
310132	epinephrine 1:1000 Injectable Solution	SY	b27e06aa-5b40-44bc-8de7-80b027580a3b	11
310132	epinephrine 500 MCG per 0.5 ML Injectable Solution	SY	b27e06aa-5b40-44bc-8de7-80b027580a3b	11
1490057	Adrenalin 1 MG/ML Injectable Solution	PSN	a5ce0c01-dd47-4997-ab09-490de65d3835	10
310132	EPINEPHrine 1 MG/ML (1:1000) Injectable Solution	PSN	a5ce0c01-dd47-4997-ab09-490de65d3835	10
1490057	epinephrine 1 MG/ML Injectable Solution [Adrenalin]	SBD	a5ce0c01-dd47-4997-ab09-490de65d3835	10
310132	epinephrine 1 MG/ML Injectable Solution	SCD	a5ce0c01-dd47-4997-ab09-490de65d3835	10
1490057	Adrenalin 1 MG/ML Injectable Solution	SY	a5ce0c01-dd47-4997-ab09-490de65d3835	10
1490057	Adrenalin 1:1000 Injectable Solution	SY	a5ce0c01-dd47-4997-ab09-490de65d3835	10
1490057	Adrenalin 30 MG per 30 ML Injectable Solution	SY	a5ce0c01-dd47-4997-ab09-490de65d3835	10
310132	epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable Solution	SY	a5ce0c01-dd47-4997-ab09-490de65d3835	10
310132	epinephrine 1:1000 Injectable Solution	SY	a5ce0c01-dd47-4997-ab09-490de65d3835	10
310132	epinephrine 500 MCG per 0.5 ML Injectable Solution	SY	a5ce0c01-dd47-4997-ab09-490de65d3835	10
310132	EPINEPHrine 1 MG/ML (1:1000) Injectable Solution	PSN	76462d55-5448-0fd0-e053-2991aa0aa49f	4
310132	epinephrine 1 MG/ML Injectable Solution	SCD	76462d55-5448-0fd0-e053-2991aa0aa49f	4
310132	epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable Solution	SY	76462d55-5448-0fd0-e053-2991aa0aa49f	4
310132	epinephrine 1:1000 Injectable Solution	SY	76462d55-5448-0fd0-e053-2991aa0aa49f	4
310132	epinephrine 500 MCG per 0.5 ML Injectable Solution	SY	76462d55-5448-0fd0-e053-2991aa0aa49f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42023-168-01	42023016801	1 VIAL in 1 CARTON (42023-168-01) / 30 mL in 1 VIAL	1 vial	2014-03-01	0000-00-00	No	No	Current
42023-168-89	42023016889	1 VIAL in 1 CARTON (42023-168-89) / 30 mL in 1 VIAL	1 vial	2020-12-04	0000-00-00	No	No	Current
42023-168-99	42023016899	1 VIAL in 1 CARTON (42023-168-99) / 30 mL in 1 VIAL	1 vial	2020-12-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Adrenalin	Par Health USA, LLC	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	24
Adrenalin	Par Health USA, LLC \| Endo USA, Inc.	2026-04-08	HUMAN PRESCRIPTION DRUG LABEL	11
Adrenalin	Par Health USA, LLC \| Endo USA, Inc.	2026-04-08	HUMAN PRESCRIPTION DRUG LABEL	10
ADRENALIN(R) INJECTION (EPINEPHRINE INJECTION, USP) 1mg/mL 30mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2022-12-09	HUMAN PRESCRIPTION DRUG LABEL	4