EPINEPHRINE

Product NDC: 51662-1706
Requested package NDC: 51662-1706-3
11-digit product format: 516621706
Labeler code: 51662
Product ID: 51662-1706_582bb7c6-e26c-48e9-e063-6394a90a0fe7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: EPINEPHRINE
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: NDA205029
Marketing category: NDA
Marketing start: 2022-03-16
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 43.

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N205029-003	EPINEPHRINE	EPINEPHRINE	1MG/ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2023-05-12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 · 133 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
2026-09-14 22:38:34	2026-08	N205029-001	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	AP	RLD, RS	2014-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205029-002	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205029-004	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2024-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205029-005	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2024-03-04	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N205029-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205029-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205029-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205029-005	AP	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: EPINEPHRINE
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1660014	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
5726eeca-db88-ba8e-e063-6294a90a927d	Available on FDA.report

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	REMEDYREPACK INC.	5ba14408-c8fb-4734-aad9-ee19696acac2	2026-08-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205029 application number: NDA205029
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 ndc (package): 51662-1706-3 ndc (product): 51662-1706 ndc11 (package): 51662170603
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
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
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
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
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	Medical Purchasing Solutions, LLC	677c33a2-4e16-406e-e053-2991aa0a4594	2022-10-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205029 application number: NDA205029

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51662-1706-3	51662170603	25 POUCH in 1 BOX (51662-1706-3) / 1 VIAL in 1 POUCH (51662-1706-2) / 1 mL in 1 VIAL (51662-1706-1)	25 pouch	2022-03-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
51662--1706 Epinephrine Injection USP (1mg/mL)	HF Acquisition Co LLC, DBA HealthFirst	2026-08-03	HUMAN PRESCRIPTION DRUG LABEL	2