EPINEPHRINE

Product NDC: 54288-600
Requested package NDC: 54288-600-01
11-digit product format: 542880600
Labeler code: 54288
Product ID: 54288-600_79bfbdaf-2a2d-4b68-8f10-3daf37fdc423
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: EPINEPHRINE
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: BPI Labs, LLC
Application: NDA205029
Marketing category: NDA
Marketing start: 2023-01-16
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: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54288-600	54288-600-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54288-600	54288-600-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54288-600	54288-600-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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

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 · 123 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	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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205029-001	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS		RLD, RS	2014-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205029-002	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205029-003	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205029-004	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205029-005	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2024-03-04	`5bbf6a4d5a75…`

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	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…`

Additional Listing Data#

Finished product: Yes
Brand name base: EPINEPHRINE
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
3fd8dd51-0aeb-43dd-9de0-c11b0330b15e	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
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
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#

Effective, Related label table
Effective	Related label
2025-02-11	These highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION, USP 10 mg/10 mL (1 mg/mL) Multiple Dose Vial, for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939
2025-02-11	These highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION, USP for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939
2025-02-11	These highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION, USP for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939
2025-01-30	These highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION, USP 10 mg/10 mL (1 mg/mL) Multiple Dose Vial, for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939
2025-01-30	These highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION, USP for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939
2025-01-30	These highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION, USP for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54288-600-01	EPINEPHRINE	10 mL in 1 VIAL	INJECTION	10		5
54288-600-01	EPINEPHRINE	1 in 1 CARTON	INJECTION	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54288-600-01	ML - Milliliter	54288-600	1088c997-e58b-42f2-a34d-0b84fdbdb4b5	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54288-600	EPINEPHRINE INJECTION [BPI LABS, LLC]	3	Current NDC, 2 package rows	20250213_3fd8dd51-0aeb-43dd-9de0-c11b0330b15e.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 · 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
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 ndc (package): 54288-600-01 ndc (product): 54288-600 ndc11 (package): 54288060001
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	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

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	3fd8dd51-0aeb-43dd-9de0-c11b0330b15e	5
310132	epinephrine 1 MG/ML Injectable Solution	SCD	3fd8dd51-0aeb-43dd-9de0-c11b0330b15e	5
310132	epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable Solution	SY	3fd8dd51-0aeb-43dd-9de0-c11b0330b15e	5
310132	epinephrine 1:1000 Injectable Solution	SY	3fd8dd51-0aeb-43dd-9de0-c11b0330b15e	5
310132	epinephrine 500 MCG per 0.5 ML Injectable Solution	SY	3fd8dd51-0aeb-43dd-9de0-c11b0330b15e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
54288-600-01	54288060001	1 VIAL in 1 CARTON (54288-600-01) / 10 mL in 1 VIAL	1 vial	2023-01-16	No	No	Current