EPINEPHRINE

Product NDC: 62250-103
Requested package NDC: 62250-103-10
11-digit product format: 622500103
Labeler code: 62250
Product ID: 62250-103_0b5e145a-fe14-458c-b8b0-b54f63296c30
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: EPINEPHRINE
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Belcher Pharmaceuticals, LLC
Application: NDA205029
Marketing category: NDA
Marketing start: 2014-08-08
Marketing end: 0000-00-00
Substance: EPINEPHRINE
Active strength: 1 mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	62250-103	62250-103-10	D	Discontinued by firm		2026-08-17

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62250-103-10	2025-07-02	C162847	48780-1	f386c649-dcb5-0266-e053-dadaa90a7c1a	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, 1 mg/mL ampule, for intravenous, intramuscular, subcutaneous, and intraocular use Initial U.S. Approval: 1939
62250-103-10	2023-01-30	C162847	48780-1	f386c649-dcb5-0266-e053-dadaa90a7c1a	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, 1 mg/mL ampule, for intravenous, intramuscular, subcutaneous, and intraocular use Initial U.S. Approval: 1939

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62250-103-01	ML - Milliliter	62250-103	c059bdce-2262-44c3-b978-ef0992075d0f	1	2014-12-01
62250-103-10	ML - Milliliter	62250-103	10aa9f4e-cd28-4bf8-94c3-65e614fcac4e	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Epinephrine	ACTIVE INGREDIENT	YKH834O4BH	EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE [BELCHER PHARMACEUTICALS, LLC]	5
Epinephrine	ACTIVE MOIETY	YKH834O4BH	EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE [BELCHER PHARMACEUTICALS, LLC]	5
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE [BELCHER PHARMACEUTICALS, LLC]	5
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE [BELCHER PHARMACEUTICALS, LLC]	5
Water	INACTIVE INGREDIENT	059QF0KO0R	EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE [BELCHER PHARMACEUTICALS, LLC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62250-103	EPINEPHRINE (EPINEPHRINE) INJECTION, SOLUTION, CONCENTRATE [BELCHER PHARMACEUTICALS, LLC]	17	Legacy NDC	20210918_e51c9ca2-6057-4830-9dcc-e8c7491f861b.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62250-103-10	62250010310	10 AMPULE in 1 BOX (62250-103-10) > 1 mL in 1 AMPULE	10 ampule	2014-08-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EPINEPHRINE	Belcher Pharmaceuticals, LLC \| Sintetica SA	2021-09-14	HUMAN PRESCRIPTION DRUG LABEL	17