Application 007513

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOPHED	NOREPINEPHRINE BITARTRATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N007513-001	LEVOPHED	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N007513-001	AP

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N007513-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N007513-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N007513-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N007513-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007513-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N007513-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007513-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007513-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007513-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007513-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007513-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007513-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N007513-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N007513-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N007513-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N007513-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N007513-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N007513-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N007513-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N007513-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N007513-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N007513-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N007513-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N007513-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N007513-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N007513-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N007513-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N007513-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N007513-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N007513-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N007513-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N007513-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N007513-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N007513-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N007513-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N007513-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N007513-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N007513-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N007513-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N007513-001	AP	1	`3a93d1ddd44b…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVOPHED	NOREPINEPHRINE BITARTRATE	Hospira, Inc.	2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 007513 application number: NDA007513
LEVOPHED	NOREPINEPHRINE BITARTRATE	Hospira, Inc.	c4de72a8-2a75-4984-ce90-e4870226dc12	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 007513 application number: NDA007513 ndc (product): 0409-3375 ndc (product): 0409-1443
LEVOPHED(R) NOREPINEPHRINE BITARTRATE	LEVOPHED(R) NOREPINEPHRINE BITARTRATE	HF Acquisition Co LLC, DBA HealthFirst	788b6c64-1b6d-0058-e053-2a91aa0aa99c	2021-02-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 007513 application number: NDA007513 ndc (product): 51662-1315

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-1443	Levophed	Norepinephrine bitartrate	Hospira, Inc.	NDA	Current
0409-1443	Levophed	Norepinephrine bitartrate	Hospira, Inc.	NDA	Current
0409-1443	Levophed	Norepinephrine bitartrate	Hospira, Inc.	NDA	Current
0409-1443	Levophed	Norepinephrine bitartrate	Hospira, Inc.	NDA	Current
0409-3375	LEVOPHED	NOREPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-3375	LEVOPHED	NOREPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-3375	LEVOPHED	NOREPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-3375	LEVOPHED	NOREPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-3375	LEVOPHED	NOREPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-3375	LEVOPHED	NOREPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-3375	LEVOPHED	NOREPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-3375	LEVOPHED	NOREPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
51662-1315	LEVOPHED(R) NOREPINEPHRINE BITARTRATE	LEVOPHED(R) NOREPINEPHRINE BITARTRATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1315	LEVOPHED(R) NOREPINEPHRINE BITARTRATE	LEVOPHED(R) NOREPINEPHRINE BITARTRATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1315	LEVOPHED(R) NOREPINEPHRINE BITARTRATE	LEVOPHED(R) NOREPINEPHRINE BITARTRATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1315	LEVOPHED(R) NOREPINEPHRINE BITARTRATE	LEVOPHED(R) NOREPINEPHRINE BITARTRATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1315	LEVOPHED(R) NOREPINEPHRINE BITARTRATE	LEVOPHED(R) NOREPINEPHRINE BITARTRATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1315	LEVOPHED(R) NOREPINEPHRINE BITARTRATE	LEVOPHED(R) NOREPINEPHRINE BITARTRATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-443	Levophed	Norepinephrine Bitartrate	General Injectables & Vaccines, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80153	SUPPL	2024-11-05
65014	SUPPL	2020-10-23
64985	SUPPL	2020-10-23
63601	SUPPL	2020-06-17
63584	SUPPL	2020-06-17
32953	SUPPL	2014-12-01
134	SUPPL	2007-10-04