epinephrine

Product NDC: 0517-1171
11-digit product format: 005171171
Labeler code: 0517
Product ID: 0517-1171_ca2af610-a1fe-420d-812c-d1ae3d07d6fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: epinephrine
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; SUBCUTANEOUS
Labeler: American Regent, Inc.
Application: ANDA207568
Marketing category: ANDA
Marketing start: 2023-01-31
Substance: EPINEPHRINE
Active strength: 1 mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207568-001	EPINEPHRINE	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2018-07-06

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	AP	2018-07-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2018-07-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2018-07-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2018-07-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2018-07-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2018-07-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	AP	2018-07-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207568-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		2018-07-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A207568-001	AP	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207568-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207568-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207568-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207568-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207568-001	AP	1	`3a93d1ddd44b…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EPINEPHRINE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YKH834O4BH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1660014	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
6add7604-71f6-4d8a-9447-17ad01fa839d	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
0517-1171-01	epinephrine	1 mL in 1 AMPULE	INJECTION, SOLUTION	1		4
0517-1171-10	epinephrine	10 in 1 BOX	INJECTION, SOLUTION	10		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-1171-01	ML - Milliliter	0517-1171	12899cb1-9d94-4b8c-b0c5-3996e74ed49d	1	2023-02-06
0517-1171-10	ML - Milliliter	0517-1171	2d07635b-64ed-4230-9732-f584b77392ae	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0517-1171	EPINEPHRINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240517_6add7604-71f6-4d8a-9447-17ad01fa839d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
epinephrine	EPINEPHRINE	American Regent, Inc.	6add7604-71f6-4d8a-9447-17ad01fa839d	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207568 application number: ANDA207568 ndc (product): 0517-1171

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
1660014	EPINEPHrine 1 MG in 1 ML Injection	PSN	6add7604-71f6-4d8a-9447-17ad01fa839d	4
1660014	1 ML epinephrine 1 MG/ML Injection	SCD	6add7604-71f6-4d8a-9447-17ad01fa839d	4
1660014	epinephrine 1 MG per 1 ML Injection	SY	6add7604-71f6-4d8a-9447-17ad01fa839d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0517-1171-01	00517117101	1 mL in 1 AMPULE	1 ml					Historical
0517-1171-10	00517117110	10 AMPULE in 1 BOX (0517-1171-10) / 1 mL in 1 AMPULE (0517-1171-01)	10 ampule	2023-01-31	0000-00-00	No	No	Current