epinephrine

Product NDC: 76420-467
Requested package NDC: 76420-467-02
11-digit product format: 764200467
Labeler code: 76420
Product ID: 76420-467_3df3dccf-4cd0-db35-e063-6394a90a08dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: epinephrine
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: ASCLEMED USA INC.
Application: NDA020800
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2010-04-01
Substance: EPINEPHRINE
Active strength: .3 mg/.3mL
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

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: epinephrine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EPINEPHRINE	.3 mg/.3mL

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
1870230	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
76f65a94-4b26-4c40-8a74-79a73afbb4e2	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76420-467-02	epinephrine	1 in 1 CASE	INJECTION	1		1
76420-467-02	epinephrine	2 in 1 CARTON	INJECTION	2		1

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 ndc (package): 76420-467-02 ndc (product): 76420-467 ndc11 (package): 76420046702
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	76f65a94-4b26-4c40-8a74-79a73afbb4e2	1
1870230	NDA020800 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	76f65a94-4b26-4c40-8a74-79a73afbb4e2	1
1870230	epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-Injector	SY	76f65a94-4b26-4c40-8a74-79a73afbb4e2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-467-02	76420046702	2 CASE in 1 CARTON (76420-467-02) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS	2 case	2025-09-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
epinephrine	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-09-04	HUMAN PRESCRIPTION DRUG LABEL	1