ADRENALIN(R)

Product NDC: 51662-1307
11-digit product format: 516621307
Labeler code: 51662
Product ID: 51662-1307_ef6c1e17-5335-ac5f-e053-2995a90a83e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ADRENALIN(R)
Dosage form: INJECTION
Route: INTRAMUSCULAR; SUBCUTANEOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: NDA204640
Marketing category: NDA
Marketing start: 2018-09-19
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: 2026-12-31
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(R)
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310132	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
76462d55-5448-0fd0-e053-2991aa0aa49f	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51662-1307-1	2020-02-07	C162847	48780-1	9d75b9d0-0bda-f424-e053-dadaa90a57ce	ADRENALIN(R) INJECTION (EPINEPHRINE INJECTION, USP) 1mg/mL 30mL VIAL
51662-1307-1	2020-01-31	C162847	48780-1	9d75b9d0-0bda-f424-e053-dadaa90a57ce	ADRENALIN(R) INJECTION (EPINEPHRINE INJECTION, USP) 1mg/mL 30mL VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51662-1307-1	ADRENALIN(R)	30 mL in 1 VIAL, MULTI-DOSE	INJECTION	30		4
51662-1307-1	ADRENALIN(R)	1 in 1 CARTON	INJECTION	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1307	ADRENALIN(R) INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	4	Current NDC, Legacy NDC, 2 package rows	20221211_76462d55-5448-0fd0-e053-2991aa0aa49f.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
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
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
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 ndc (product): 51662-1307

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
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	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1307-1	51662130701	1 VIAL, MULTI-DOSE in 1 CARTON (51662-1307-1) / 30 mL in 1 VIAL, MULTI-DOSE	2018-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ADRENALIN(R) INJECTION (EPINEPHRINE INJECTION, USP) 1mg/mL 30mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2022-12-09	HUMAN PRESCRIPTION DRUG LABEL	4