Application 209359

Type: NDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPINEPHRINE (COPACKAGED)	EPINEPHRINE	SOLUTION;INTRAVENOUS	1MG/10ML (0.1MG/ML)	Yes	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…`

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 ndc (product): 71872-7250

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-4933	EPINEPHRINE	epinephrine	Hospira, Inc.	NDA	Current
0409-4933	EPINEPHRINE	epinephrine	Hospira, Inc.	NDA	Current
0409-4933	EPINEPHRINE	epinephrine	Hospira, Inc.	NDA	Current
51662-1531	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1531	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
71872-7250	EPINEPHRINE	epinephrine	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82215	SUPPL	2025-05-21
82201	SUPPL	2025-05-19
72500	SUPPL	2022-10-31
72488	SUPPL	2022-10-28
69992	SUPPL	2022-01-28
63760	ORIG	2020-06-30
62772	ORIG	2020-04-30
60787	ORIG	2019-11-07