Epinephrine

Product NDC: 84549-018
11-digit product format: 845490018
Labeler code: 84549
Product ID: 84549-018_3d728e53-92c1-114e-e063-6394a90ad404
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Epinephrine
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: ProPharma Distribution
Application: NDA211363
Marketing category: NDA
Marketing start: 2023-01-30
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
N211363-001	EPINEPHRINE	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-08-15

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	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211363-001	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-08-15	`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
3d728e53-92c2-114e-e063-6394a90ad404	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84549-018-01	Epinephrine	10 mL in 1 SYRINGE	INJECTION	10		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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epinephrine	EPINEPHRINE	A-S Medication Solutions	6e811e28-0199-4df7-a916-5940c632401d	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211363 application number: NDA211363
Epinephrine	EPINEPHRINE	REMEDYREPACK INC.	0172280c-f7d6-4613-9dbd-f94d3ae5825a	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211363 application number: NDA211363
EPINEPHRINE	EPINEPHRINE	Henry Schein, Inc.	3b1ac82f-6920-4e40-a77e-598398679f2d	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211363 application number: NDA211363
Epinephrine	EPINEPHRINE	ProPharma Distribution	3d728e53-92c2-114e-e063-6394a90ad404	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211363 application number: NDA211363 ndc (product): 84549-018
Epinephrine	EPINEPHRINE	International Medication Systems, Limited	f2b5f15b-8541-466a-a27a-ee57bc4aac67	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211363 application number: NDA211363
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	f9c82678-5f4d-fded-e053-6394a90ac16d	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211363 application number: NDA211363
Epinephrine	EPINEPHRINE	Medical Purchasing Solutions, LLC	093312af-6eed-1f4b-e063-6294a90a155d	2023-11-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211363 application number: NDA211363

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	3d728e53-92c2-114e-e063-6394a90ad404	1
727373	10 ML epinephrine 0.1 MG/ML Prefilled Syringe	SCD	3d728e53-92c2-114e-e063-6394a90ad404	1
727373	epinephrine 1 MG per 10 ML Prefilled Syringe	SY	3d728e53-92c2-114e-e063-6394a90ad404	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84549-018-01	84549001801	10 mL in 1 SYRINGE (84549-018-01)	10 ml	2025-09-01	No	No	Current