LEVOPHED

Product NDC: 0409-0161
11-digit product format: 004090161
Labeler code: 0409
Product ID: 0409-0161_0fe551f3-b031-4c1b-b567-cc2fc6a52105
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NOREPINEPHRINE BITARTRATE
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: NDA007513
Marketing category: NDA
Marketing start: 2024-03-11
Substance: NOREPINEPHRINE BITARTRATE
Active strength: 1 mg/mL
Pharmacologic classes: Catecholamine [EPC], Catecholamines [CS]
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 42.

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 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N007513-001	LEVOPHED	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	N007513-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N007513-001	AP	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NOREPINEPHRINE BITARTRATE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IFY5PE3ZRW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
209217	Internal RxNorm lookup
242969	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
2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ab36713-99a4-1d04-c42f-907afc73b6f9	Product name	7	20260105
209a4db0-2639-413d-9ad3-274ad7be11f7	Product name	1	20230912
08ddeef6-6d79-428b-a00b-432b50fc2b32	Product name	1	20230831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0409-0161-01	LEVOPHED	4 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	4		5
0409-0161-10	LEVOPHED	10 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	10		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-0161-01	ML - Milliliter	0409-0161	c1fccfe9-96d1-41da-9442-aa7a273312bc	1	2024-04-05
0409-0161-10	ML - Milliliter	0409-0161	19a1d79a-897e-4d18-b3bc-d1591eca92e8	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-0161	LEVOPHED (NOREPINEPHRINE BITARTRATE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]	4	Current NDC, 2 package rows	20240805_2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10.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 · 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 ndc (product): 0409-0161
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IFY5PE3ZRW	NOREPINEPHRINE BITARTRATE	108341-18-0	NOREPINEPHRINE BITARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
209217	Levophed 4 MG in 4 ML Injection	PSN	2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10	5
242969	norepinephrine bitartrate 4 MG in 4 mL Injection	PSN	2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10	5
209217	4 ML norepinephrine 1 MG/ML Injection [Levophed]	SBD	2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10	5
242969	4 ML norepinephrine 1 MG/ML Injection	SCD	2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10	5
209217	4 ML Levophed 1 MG/ML Injection	SY	2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10	5
209217	Levophed 4 MG per 4 ML Injection	SY	2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10	5
242969	norepinephrine (as bitartrate) 4 MG per 4 ML Injection	SY	2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10	5
242969	norepinephrine 4 MG per 4 ML Injection	SY	2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0409-0161-01	00409016101	4 mL in 1 VIAL, SINGLE-DOSE	4 ml				Historical
0409-0161-10	00409016110	10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0161-10) / 4 mL in 1 VIAL, SINGLE-DOSE (0409-0161-01)		2024-03-11	No	No	Current