Application 205029

Type: NDA
Sponsor: BELCHER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPINEPHRINE	EPINEPHRINE	SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	Yes	Yes
002	EPINEPHRINE	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	10MG/10ML (1MG/ML)	Yes	No
003	EPINEPHRINE	EPINEPHRINE	SOLUTION;INTRAVENOUS	1MG/ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No
004	EPINEPHRINE	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	30MG/30ML (1MG/ML)	Yes	Yes
005	EPINEPHRINE	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	1MG/ML (1MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205029-001	EPINEPHRINE	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	AP	RLD, RS	2014-07-29
N205029-002	EPINEPHRINE	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-02-04
N205029-003	EPINEPHRINE	EPINEPHRINE	1MG/ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2023-05-12
N205029-004	EPINEPHRINE	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2024-02-14
N205029-005	EPINEPHRINE	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2024-03-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N205029-001	AP
N205029-002	AP
N205029-004	AP
N205029-005	AP

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 · 128 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
2026-08-18 06:07:40	2026-07	N205029-001	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	AP	RLD, RS	2014-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205029-002	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205029-003	EPINEPHRINE	1MG/ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2023-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205029-004	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2024-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205029-005	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2024-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205029-001	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	AP	RLD, RS	2014-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205029-002	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205029-003	EPINEPHRINE	1MG/ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2023-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205029-004	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2024-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205029-005	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205029-001	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	AP	RLD, RS	2014-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205029-002	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205029-003	EPINEPHRINE	1MG/ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2023-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205029-004	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2024-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205029-005	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205029-001	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	AP	RLD, RS	2014-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205029-002	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205029-003	EPINEPHRINE	1MG/ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2023-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205029-004	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205029-005	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205029-001	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	AP	RLD, RS	2014-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205029-002	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205029-003	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205029-004	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205029-005	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205029-001	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	AP	RLD, RS	2014-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205029-002	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205029-003	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205029-004	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205029-005	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205029-001	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	AP	RLD, RS	2014-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205029-002	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205029-003	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205029-004	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205029-005	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205029-001	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	AP	RLD, RS	2014-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205029-002	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205029-003	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205029-004	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205029-005	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-03-04	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N205029-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205029-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205029-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205029-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205029-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205029-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205029-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205029-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205029-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205029-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205029-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205029-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205029-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205029-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205029-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205029-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205029-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205029-001	AP	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205029-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205029-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205029-004	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205029-005	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 190 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N205029-001	10004700	2034-08-14	U-2325	Drug product, Delist requested	2018-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205029-001	10039728	2034-08-14	U-1828	Delist requested	2018-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205029-001	9283197	2034-08-15	U-1829	Drug product, Delist requested	2016-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205029-001	9283197	2034-08-15	U-1828	Drug product, Delist requested	2016-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205029-001	9283197	2034-08-15	U-1830	Drug product, Delist requested	2016-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205029-001	10004700	2034-08-14	U-2325	Drug product, Delist requested	2018-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205029-001	10039728	2034-08-14	U-1828	Delist requested	2018-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205029-001	9283197	2034-08-15	U-1829	Drug product, Delist requested	2016-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205029-001	9283197	2034-08-15	U-1828	Drug product, Delist requested	2016-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205029-001	9283197	2034-08-15	U-1830	Drug product, Delist requested	2016-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205029-001	10004700	2034-08-14	U-2325	Drug product, Delist requested	2018-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205029-001	10039728	2034-08-14	U-1828	Delist requested	2018-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205029-001	9283197	2034-08-15	U-1829	Drug product, Delist requested	2016-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205029-001	9283197	2034-08-15	U-1828	Drug product, Delist requested	2016-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205029-001	9283197	2034-08-15	U-1830	Drug product, Delist requested	2016-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205029-001	10004700	2034-08-14	U-2325	Drug product, Delist requested	2018-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205029-001	10039728	2034-08-14	U-1828	Delist requested	2018-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205029-001	9283197	2034-08-15	U-1829	Drug product, Delist requested	2016-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205029-001	9283197	2034-08-15	U-1828	Drug product, Delist requested	2016-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205029-001	9283197	2034-08-15	U-1830	Drug product, Delist requested	2016-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205029-001	10004700	2034-08-14	U-2325	Drug product, Delist requested	2018-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205029-001	10039728	2034-08-14	U-1828	Delist requested	2018-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205029-001	9283197	2034-08-15	U-1829	Drug product, Delist requested	2016-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205029-001	9283197	2034-08-15	U-1828	Drug product, Delist requested	2016-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205029-001	9283197	2034-08-15	U-1830	Drug product, Delist requested	2016-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205029-001	10004700	2034-08-14	U-2325	Drug product, Delist requested	2018-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205029-001	10039728	2034-08-14	U-1828	Delist requested	2018-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205029-001	9283197	2034-08-15	U-1829	Drug product, Delist requested	2016-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205029-001	9283197	2034-08-15	U-1828	Drug product, Delist requested	2016-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205029-001	9283197	2034-08-15	U-1830	Drug product, Delist requested	2016-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205029-001	10004700	2034-08-14	U-2325	Drug product, Delist requested	2018-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205029-001	10039728	2034-08-14	U-1828	Delist requested	2018-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205029-001	9283197	2034-08-15	U-1829	Drug product, Delist requested	2016-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205029-001	9283197	2034-08-15	U-1828	Drug product, Delist requested	2016-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205029-001	9283197	2034-08-15	U-1830	Drug product, Delist requested	2016-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205029-001	10004700	2034-08-14	U-2325	Drug product, Delist requested	2018-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205029-001	10039728	2034-08-14	U-1828	Delist requested	2018-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205029-001	9283197	2034-08-15	U-1829	Drug product, Delist requested	2016-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205029-001	9283197	2034-08-15	U-1828	Drug product, Delist requested	2016-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205029-001	9283197	2034-08-15	U-1830	Drug product, Delist requested	2016-04-07	`d06236e962d9…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	5726eeca-db88-ba8e-e063-6294a90a927d	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205029 application number: NDA205029
Epinephrine	EPINEPHRINE	A-S Medication Solutions	386519ba-7a44-4edd-9eb1-748419b7a71b	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205029 application number: NDA205029 ndc (product): 50090-3039
EPINEPHRINE	EPINEPHRINE	Henry Schein, Inc.	af10f2bb-b0ad-45a6-b525-e715613350af	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205029 application number: NDA205029 ndc (product): 0404-9857
EPINEPHRINE	EPINEPHRINE	BPI Labs, LLC	7499cbca-b8fe-4fc3-a318-13859ab989a7	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205029 application number: NDA205029
EPINEPHRINE	EPINEPHRINE	BPI Labs, LLC	3fd8dd51-0aeb-43dd-9de0-c11b0330b15e	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205029 application number: NDA205029
EPINEPHRINE	EPINEPHRINE	BPI Labs, LLC	db18519b-82a9-435b-85c7-a040d644f057	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205029 application number: NDA205029 ndc (product): 54288-120
Epinephrine	EPINEPHRINE	BPI Labs, LLC	5b5282a9-b149-4f0a-978e-5adbf48ec8aa	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205029 application number: NDA205029 ndc (product): 54288-103
Epinephrine	EPINEPHRINE	ProPharma Distribution	384445ac-0696-e367-e063-6394a90a019f	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205029 application number: NDA205029
EPINEPHRINE	EPINEPHRINE	Medical Purchasing Solutions, LLC.	409581e7-ab70-41f3-e063-6294a90a15dc	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205029 application number: NDA205029
EPINEPHRINE	EPINEPHRINE	REMEDYREPACK INC.	5ba14408-c8fb-4734-aad9-ee19696acac2	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205029 application number: NDA205029
Epinephrine	EPINEPHRINE	Medical Purchasing Solutions, LLC	677c33a2-4e16-406e-e053-2991aa0a4594	2022-10-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205029 application number: NDA205029 ndc (product): 71872-7117

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9857	EPINEPHRINE	EPINEPHRINE	Henry Schein, Inc.	NDA	Current
0404-9857	EPINEPHRINE	EPINEPHRINE	Henry Schein, Inc.	NDA	Current
0404-9857	EPINEPHRINE	EPINEPHRINE	Henry Schein, Inc.	NDA	Current
50090-3039	Epinephrine	Epinephrine	A-S Medication Solutions	NDA	Current
52584-103	EPINEPHRINE	EPINEPHRINE	General Injectables and Vaccines, Inc.	NDA	Current
52584-103	EPINEPHRINE	EPINEPHRINE	General Injectables and Vaccines, Inc.	NDA	Current
52584-103	EPINEPHRINE	EPINEPHRINE	General Injectables and Vaccines, Inc.	NDA	Current
52584-103	EPINEPHRINE	EPINEPHRINE	General Injectables and Vaccines, Inc.	NDA	Current
52584-103	EPINEPHRINE	EPINEPHRINE	General Injectables and Vaccines, Inc.	NDA	Current
54288-103	Epinephrine	Epinephrine	BPI Labs, LLC	NDA	Current
54288-103	Epinephrine	Epinephrine	BPI Labs, LLC	NDA	Current
54288-103	Epinephrine	Epinephrine	BPI Labs, LLC	NDA	Current
54288-103	Epinephrine	Epinephrine	BPI Labs, LLC	NDA	Current
54288-120	EPINEPHRINE	EPINEPHRINE	BPI Labs, LLC	NDA	Current
54288-120	EPINEPHRINE	EPINEPHRINE	BPI Labs, LLC	NDA	Current
62250-102	EPINEPHRINE	EPINEPHRINE	Belcher Pharmaceuticals, LLC	NDA	Current
62250-103	EPINEPHRINE	EPINEPHRINE	Belcher Pharmaceuticals, LLC	NDA	Current
62250-103	EPINEPHRINE	EPINEPHRINE	Belcher Pharmaceuticals, LLC	NDA	Current
62250-103	EPINEPHRINE	EPINEPHRINE	Belcher Pharmaceuticals, LLC	NDA	Current
62250-103	EPINEPHRINE	EPINEPHRINE	Belcher Pharmaceuticals, LLC	NDA	Current
62250-103	EPINEPHRINE	EPINEPHRINE	Belcher Pharmaceuticals, LLC	NDA	Current
62250-103	EPINEPHRINE	EPINEPHRINE	Belcher Pharmaceuticals, LLC	NDA	Current
70518-1215	Epinephrine	Epinephrine	REMEDYREPACK INC.	NDA	Current
70518-1215	Epinephrine	Epinephrine	REMEDYREPACK INC.	NDA	Current
70518-1215	Epinephrine	Epinephrine	REMEDYREPACK INC.	NDA	Current
70518-1215	Epinephrine	Epinephrine	REMEDYREPACK INC.	NDA	Current
71872-7117	Epinephrine	Epinephrine	Medical Purchasing Solutions, LLC	NDA	Current
71872-7117	Epinephrine	Epinephrine	Medical Purchasing Solutions, LLC	NDA	Current
71872-7117	Epinephrine	Epinephrine	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83605	SUPPL	2025-09-30
83602	SUPPL	2025-09-30
82739	SUPPL	2025-07-07
82709	SUPPL	2025-06-30
78408	SUPPL	2024-05-07
78407	SUPPL	2024-05-07
77605	SUPPL	2024-02-23
77603	SUPPL	2024-02-23
74249	SUPPL	2023-05-15
74242	SUPPL	2023-05-15
73864	SUPPL	2023-04-04
73865	SUPPL	2023-03-27
68622	SUPPL	2021-09-15
68594	SUPPL	2021-09-13
67925	SUPPL	2021-06-28
67898	SUPPL	2021-06-24
40434	SUPPL	2016-05-20
10415	SUPPL	2016-05-19
40433	SUPPL	2016-02-18
32618	SUPPL	2016-02-12
19616	SUPPL	2015-10-27
32617	SUPPL	2015-10-26
43482	ORIG	2015-03-31
19615	ORIG	2014-08-14
32616	ORIG	2014-07-31