epinephrine

Product NDC: 68788-6376
11-digit product format: 687886376
Labeler code: 68788
Product ID: 68788-6376_9a010290-186a-4182-a6bd-c6ae75b3cbeb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: epinephrine
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Preferred Pharmaceuticals Inc.
Application: NDA020800
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-04-14
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	68788-6376		I	Inactivated by FDA		2026-08-10
excluded package	package	68788-6376	68788-6376-2	I	Inactivated by FDA		2026-08-10

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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-6376-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-6376-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-6376-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-6376-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-6376-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-6376-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-6376-2	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-6376-2	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-6376-2	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-6376-2	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-6376-2	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-6376-2	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68788-6376-2	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68788-6376-2	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68788-6376-2	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68788-6376-2	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68788-6376-2	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68788-6376-2	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68788-6376-2	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68788-6376-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68788-6376-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68788-6376-2	E	Excluded after deficient or non-compliant submission was not corrected	`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
N020800-001	TWINJECT	EPINEPHRINE	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30
N020800-002	TWINJECT	EPINEPHRINE	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28
N020800-003	ADRENACLICK	EPINEPHRINE	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25
N020800-004	ADRENACLICK	EPINEPHRINE	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020800-003	BX
N020800-004	BX

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	N020800-001	TWINJECT	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020800-002	TWINJECT	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020800-001	TWINJECT	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020800-002	TWINJECT	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020800-001	TWINJECT	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020800-002	TWINJECT	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N020800-003	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020800-004	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020800-003	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020800-004	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020800-003	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020800-004	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020800-003	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020800-004	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020800-003	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020800-004	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020800-003	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020800-004	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020800-003	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020800-004	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020800-003	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020800-004	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020800-003	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020800-004	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020800-003	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020800-004	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020800-003	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020800-004	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020800-003	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020800-004	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020800-003	BX	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020800-004	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020800-003	BX	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020800-004	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-003	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-004	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020800-003	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-004	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020800-003	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-004	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020800-003	BX	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020800-004	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020800-003	BX	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-004	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020800-003	BX	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020800-004	BX	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 182 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-001	7297136	2025-01-18	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-001	7621891	2025-02-04	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-002	7297136	2025-01-18	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-002	7621891	2025-02-04	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-003	10166334	2025-01-21	Drug product	2020-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-003	7905352	2027-04-12	Drug product	2017-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-004	10166334	2025-01-21	Drug product	2020-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-004	7905352	2027-04-12	Drug product	2017-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020800-001	7297136	2025-01-18	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-001	7621891	2025-02-04	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-002	7297136	2025-01-18	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-002	7621891	2025-02-04	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-003	10166334	2025-01-21	Drug product	2020-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-003	7905352	2027-04-12	Drug product	2017-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-004	10166334	2025-01-21	Drug product	2020-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-004	7905352	2027-04-12	Drug product	2017-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020800-001	7297136	2025-01-18	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-001	7621891	2025-02-04	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-002	7297136	2025-01-18	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-002	7621891	2025-02-04	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-003	10166334	2025-01-21	Drug product	2020-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-003	7905352	2027-04-12	Drug product	2017-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-004	10166334	2025-01-21	Drug product	2020-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-004	7905352	2027-04-12	Drug product	2017-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020800-001	7297136	2025-01-18	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020800-001	7621891	2025-02-04	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020800-002	7297136	2025-01-18	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020800-002	7621891	2025-02-04	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020800-003	7905352	2027-04-12	Drug product	2017-06-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020800-004	7905352	2027-04-12	Drug product	2017-06-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020800-001	7297136	2025-01-18	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-001	7621891	2025-02-04	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-002	7297136	2025-01-18	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-002	7621891	2025-02-04	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-003	10166334	2025-01-21	Drug product	2020-02-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-003	7905352	2027-04-12	Drug product	2017-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-004	10166334	2025-01-21	Drug product	2020-02-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-004	7905352	2027-04-12	Drug product	2017-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020800-001	7297136	2025-01-18	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020800-001	7621891	2025-02-04	Drug product		`782e0a99824c…`

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
68788-6376-2	2020-01-31	C162847	48780-1	9d75b9d0-7834-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use EPINEPHRINE INJECTION, USP AUTO-INJECTOR safely and effectively. See full prescribing information for EPINEPHRINE INJECTION, USP AUTO-INJECTOR. Epinephrine injection, USP auto-injector 0.3 mg, 0.15 mg, for intramuscular or subcutaneous use Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-6376-2	epinephrine	2 in 1 CARTON	INJECTION	2		1
68788-6376-2	epinephrine	1 in 1 CASE	INJECTION	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-6376	EPINEPHRINE INJECTION [PREFERRED PHARMACEUTICALS INC.]	1	Legacy NDC, 2 package rows	20160415_9a010290-186a-4182-a6bd-c6ae75b3cbeb.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	REMEDYREPACK INC.	c66de0d3-3b0f-4e52-a712-60357a107676	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
epinephrine	EPINEPHRINE	Amneal Pharmaceuticals of New York LLC	e13f05f1-7d21-49bb-b8d5-24bf9301c3d7	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
epinephrine	EPINEPHRINE	REMEDYREPACK INC.	bfc7ab3d-1e0e-4fd9-b6df-09603eb5808c	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
epinephrine	EPINEPHRINE	Sportpharm LLC	e7798493-9407-4a5d-9c90-0cc336c59ec1	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
Epinephrine Pediatrics	EPINEPHRINE 0.15 PEDIATRICS	Sina Health Inc	287930f8-c5c6-56bd-e063-6394a90ad32e	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
Epinephrine 0.3 Adults	EPINEPHRINE 0.3 ADULTS	Sina Health Inc	28642ad9-b839-ce3a-e063-6394a90ab866	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
epinephrine	EPINEPHRINE	A-S Medication Solutions	a5134e63-9a31-4573-826f-b442d069b3e6	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
epinephrine	EPINEPHRINE	ASCLEMED USA INC.	76f65a94-4b26-4c40-8a74-79a73afbb4e2	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
Epinephrine	EPINEPHRINE	Advanced Rx Pharmacy of Tennessee, LLC	f4d7aca4-0acd-74c2-e053-2995a90a9d94	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
epinephrine	EPINEPHRINE	Asclemed USA, Inc.	0a29fe62-e241-4272-b91c-c1036b031cd4	2024-08-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	75dbc3f5-9caf-9f55-e053-2a91aa0a4719	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800

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
1870230	EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-Injector	PSN	9a010290-186a-4182-a6bd-c6ae75b3cbeb	1
1870230	NDA020800 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	9a010290-186a-4182-a6bd-c6ae75b3cbeb	1
1870230	epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-Injector	SY	9a010290-186a-4182-a6bd-c6ae75b3cbeb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68788-6376-2	68788637602	2 in 1 CARTON	Historical