Application 204640

Type: NDA
Sponsor: PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADRENALIN	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	Yes	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…`

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 ndc (product): 51662-1307

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42023-168	Adrenalin	epinephrine	Par Pharmaceutical, Inc.	NDA	Current
42023-168	Adrenalin	epinephrine	Par Pharmaceutical, Inc.	NDA	Current
42023-168	Adrenalin	epinephrine	Par Pharmaceutical, Inc.	NDA	Current
42023-168	Adrenalin	epinephrine	Par Pharmaceutical, Inc.	NDA	Current
42023-168	Adrenalin	epinephrine	Par Pharmaceutical, Inc.	NDA	Current
42023-168	Adrenalin	epinephrine	Par Pharmaceutical, Inc.	NDA	Current
51662-1307	ADRENALIN(R)	ADRENALIN(R)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1307	ADRENALIN(R)	ADRENALIN(R)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1307	ADRENALIN(R)	ADRENALIN(R)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1307	ADRENALIN(R)	ADRENALIN(R)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85856	SUPPL	2026-05-08
73121	SUPPL	2023-01-09
73113	SUPPL	2023-01-06
61003	SUPPL	2019-11-20
57497	SUPPL	2019-02-11
57379	SUPPL	2019-01-30
49402	SUPPL	2017-08-15
49339	SUPPL	2017-08-11
40405	SUPPL	2016-05-20
10374	SUPPL	2016-05-19
10373	SUPPL	2015-12-30
40404	SUPPL	2015-12-28
43471	ORIG	2014-03-06
24475	ORIG	2014-03-06
10372	ORIG	2013-12-20
40403	ORIG	2013-12-19