EPINEPHRINE

Product NDC: 51662-1531
11-digit product format: 516621531
Labeler code: 51662
Product ID: 51662-1531_1032c441-4e3d-930a-e063-6394a90a5f35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: EPINEPHRINE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: NDA209359
Marketing category: NDA
Marketing start: 2021-04-25
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
N209359-001	EPINEPHRINE	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2019-11-05

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209359-001	EPINEPHRINE (COPACKAGED)	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209359-001	EPINEPHRINE (COPACKAGED)	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209359-001	EPINEPHRINE (COPACKAGED)	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209359-001	EPINEPHRINE (COPACKAGED)	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209359-001	EPINEPHRINE (COPACKAGED)	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-11-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209359-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-11-05	`a50c72e98297…`

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
727373	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
c0d1def8-9f47-0d3e-e053-2995a90af955	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	SPL version
51662-1531-1	EPINEPHRINE	10 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	10	3
51662-1531-1	EPINEPHRINE	1 in 1 CARTON	INJECTION, SOLUTION	1	3
51662-1531-2	EPINEPHRINE	1 in 1 POUCH	INJECTION, SOLUTION	1	3
51662-1531-2	EPINEPHRINE	1 in 1 CARTON	INJECTION, SOLUTION	1	3
51662-1531-3	EPINEPHRINE	50 in 1 CARTON	INJECTION, SOLUTION	50	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1531	EPINEPHRINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	3	Current NDC, Legacy NDC, 5 package rows	20240131_c0d1def8-9f47-0d3e-e053-2995a90af955.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	c0d1def8-9f47-0d3e-e053-2995a90af955	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209359 application number: NDA209359 ndc (product): 51662-1531
EPINEPHRINE	EPINEPHRINE	Medical Purchasing Solutions, LLC	c4327095-3a89-d86a-e053-2a95a90ac255	2023-04-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209359 application number: NDA209359

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
727373	EPINEPHrine 1 MG in 10 ML Prefilled Syringe	PSN	c0d1def8-9f47-0d3e-e053-2995a90af955	3
727373	10 ML epinephrine 0.1 MG/ML Prefilled Syringe	SCD	c0d1def8-9f47-0d3e-e053-2995a90af955	3
727373	epinephrine 1 MG per 10 ML Prefilled Syringe	SY	c0d1def8-9f47-0d3e-e053-2995a90af955	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1531-1	51662153101	1 SYRINGE, GLASS in 1 CARTON (51662-1531-1) / 10 mL in 1 SYRINGE, GLASS		2021-04-25	0000-00-00	No	No	Current
51662-1531-2	51662153102	1 in 1 POUCH						Historical
51662-1531-3	51662153103	50 POUCH in 1 CARTON (51662-1531-3) / 1 CARTON in 1 POUCH (51662-1531-2) / 1 SYRINGE, GLASS in 1 CARTON / 10 mL in 1 SYRINGE, GLASS	50 pouch	2021-04-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EPINEPHRINE INJECTION, USP 1mg/10mL (0.1mg/mL) 10mL SYR	HF Acquisition Co LLC, DBA HealthFirst	2024-01-30	HUMAN PRESCRIPTION DRUG LABEL	3