EpiPen

Product NDC: 55045-3207
11-digit product format: 550453207
Labeler code: 55045
Product ID: 55045-3207_f72addbb-85a1-4830-b6db-c2e964b03385
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Epinephrine
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Dispensing Solutions, Inc.
Application: NDA019430
Marketing category: NDA
Marketing start: 1987-12-22
Marketing end: 0000-00-00
Substance: EPINEPHRINE
Active strength: 0 mg/.3mL
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: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55045-3207		I	Inactivated by FDA		2026-08-03
excluded package	package	55045-3207	55045-3207-2	I	Inactivated by FDA		2026-08-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55045-3207-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55045-3207-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55045-3207-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55045-3207-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55045-3207-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55045-3207-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55045-3207-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55045-3207-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55045-3207-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55045-3207-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55045-3207-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55045-3207-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55045-3207-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55045-3207-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55045-3207-2	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55045-3207-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55045-3207-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55045-3207-2	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55045-3207-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55045-3207-2	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	55045-3207-2	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	55045-3207-2	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019430-001	EPIPEN	EPINEPHRINE	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22
N019430-002	EPIPEN JR.	EPINEPHRINE	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22
N019430-003	EPIPEN E Z PEN	EPINEPHRINE	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03
N019430-004	EPI E Z PEN JR	EPINEPHRINE	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N019430-001	AB
N019430-002	AB

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 5 · 164 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	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019430-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019430-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019430-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019430-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019430-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019430-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019430-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019430-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019430-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019430-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019430-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019430-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019430-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019430-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019430-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019430-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019430-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019430-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019430-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019430-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019430-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019430-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019430-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019430-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019430-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019430-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019430-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019430-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019430-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019430-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019430-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019430-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019430-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 390 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-001	7449012	2025-09-11	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-001	7794432	2025-09-11	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-001	8048035	2025-09-11	Drug product	2011-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-001	8870827	2025-09-11	Drug product	2014-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-001	9586010	2025-09-11	Drug product	2017-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-002	7449012	2025-09-11	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-002	7794432	2025-09-11	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-002	8048035	2025-09-11	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-002	8870827	2025-09-11	Drug product	2014-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-002	9586010	2025-09-11	Drug product	2017-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019430-001	7449012	2025-09-11	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-001	7794432	2025-09-11	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-001	8048035	2025-09-11	Drug product	2011-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-001	8870827	2025-09-11	Drug product	2014-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-001	9586010	2025-09-11	Drug product	2017-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-002	7449012	2025-09-11	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-002	7794432	2025-09-11	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-002	8048035	2025-09-11	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-002	8870827	2025-09-11	Drug product	2014-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-002	9586010	2025-09-11	Drug product	2017-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-001	7449012	2025-09-11	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-001	7794432	2025-09-11	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-001	8048035	2025-09-11	Drug product	2011-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-001	8870827	2025-09-11	Drug product	2014-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-001	9586010	2025-09-11	Drug product	2017-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-002	7449012	2025-09-11	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-002	7794432	2025-09-11	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-002	8048035	2025-09-11	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-002	8870827	2025-09-11	Drug product	2014-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-002	9586010	2025-09-11	Drug product	2017-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-001	7449012	2025-09-11	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-001	7794432	2025-09-11	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-001	8048035	2025-09-11	Drug product	2011-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-001	8870827	2025-09-11	Drug product	2014-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-001	9586010	2025-09-11	Drug product	2017-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-002	7449012	2025-09-11	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-002	7794432	2025-09-11	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-002	8048035	2025-09-11	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-002	8870827	2025-09-11	Drug product	2014-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-002	9586010	2025-09-11	Drug product	2017-05-12	`b8a1b40f171c…`

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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55045-3207-2	2019-11-13	C162847	48780-1	97449f38-b786-f6ea-e053-dbdaa90aa703	EpiPen ® (epinephrine) Auto-Injector 0.3 mg EpiPen ® = one dose of 0.30 mg epinephrine (USP, 1:1000, 0.3 mL) EpiPen ® JR (epinephrine) Auto-Injector 0.15 mg EpiPen ® Jr = one dose of 0.15 mg epinephrine (USP, 1:2000, 0.3 mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55045-3207-2	EpiPen	1 in 1 CONTAINER	INJECTION	1		2
55045-3207-2	EpiPen	1 in 1 CARTON	INJECTION	1		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Epinephrine	ACTIVE INGREDIENT	YKH834O4BH	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2
Epinephrine	ACTIVE MOIETY	YKH834O4BH	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2
Nitrogen	INACTIVE INGREDIENT	N762921K75	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2
Sodium Metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55045-3207	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2	Legacy NDC, 2 package rows	20120926_f3f1a483-e29a-4e3e-b677-16fa87fe5e5a.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epinephrine 0.3 Adults	EPINEPHRINE 0.3 ADULTS	Sina Health Inc	2865e9a5-1228-e2bc-e063-6394a90af94e	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430
Epinephrine 0.15 Pediatrics	EPINEPHRINE 0.15 PEDIATRICS	Sina Health Inc	28649bcc-648c-c977-e063-6394a90a0b2b	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430
Epinephrine	EPINEPHRINE	A-S Medication Solutions	b7a4171c-7934-4723-a140-bd93ea84aae1	2023-11-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430
EPIPEN	EPINEPHRINE	Asclemed USA, Inc.	311af6d9-20c0-4b87-b236-4185bfa49988	2023-08-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430
Epinephrine	EPINEPHRINE	Medical Purchasing Solutions, LLC	6bce7d5c-bb6b-1f36-e053-2a91aa0a68ab	2023-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430
Epinephrine	EPINEPHRINE	Medical Purchasing Solutions, LLC	6bdca08a-65bf-f56c-e053-2a91aa0a56d8	2023-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430
EPIPEN	EPINEPHRINE	Viatris Specialty LLC	7560c201-9246-487c-a13b-6295db04274a	2023-02-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430
Epinephrine	EPINEPHRINE	Viatris Specialty LLC	778ac6ae-6bcb-47a4-bcb3-8dd0da9f8836	2023-02-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	75e96faa-545b-52d6-e053-2991aa0a8fb8	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430

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
1870207	EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-Injector	PSN	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
727347	EpiPen 0.3 MG in 0.3 ML Auto-Injector	PSN	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
727347	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector [Epipen]	SBD	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
1870207	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
727347	0.3 ML Epipen 1 MG/ML Auto-Injector	SY	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
1870207	epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-Injector	SY	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
727347	Epipen 0.3 MG per 0.3 ML Auto-Injector	SY	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
727347	NDA019430 0.3 ML Epipen 1 MG/ML Auto-Injector	SY	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55045-3207-2	55045320702	1 in 1 CONTAINER	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EpiPen	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-09-25	HUMAN PRESCRIPTION DRUG LABEL	2