NOREPINEPHRINE BITARTRATE

Product NDC: 42023-245
11-digit product format: 420230245
Labeler code: 42023
Product ID: 42023-245_88d4fb55-561d-486a-b061-f7cc17b45e33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NOREPINEPHRINE IN SODIUM CHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Par Pharmaceutical, Inc.
Application: NDA214628
Marketing category: NDA
Marketing start: 2023-01-04
Marketing end: 0000-00-00
Substance: NOREPINEPHRINE BITARTRATE
Active strength: 4 mg/250mL
Pharmacologic classes: Catecholamine [EPC], Catecholamines [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42023-245		I	Inactivated by FDA		2026-08-11
excluded package	package	42023-245	42023-245-10	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42023-245-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42023-245-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42023-245-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42023-245-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42023-245-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42023-245-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42023-245-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42023-245-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42023-245-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42023-245-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42023-245-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42023-245-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42023-245-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42023-245-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42023-245-10	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06
N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06
N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214628-001	10159657	2038-01-30		Drug product	2022-11-02
N214628-001	10226436	2038-01-30	U-3461	Drug product	2022-11-02
N214628-001	10420735	2038-01-30	U-3461	Drug product	2022-11-02
N214628-001	10568850	2038-01-30		Drug product	2022-11-02
N214628-001	11413259	2038-01-30	U-3461	Drug product	2022-11-02
N214628-001	11602508	2038-01-30		Drug product	2023-03-14
N214628-001	12245996	2038-01-30		Drug product	2025-03-26
N214628-002	10159657	2038-01-30		Drug product	2022-11-02
N214628-002	10226436	2038-01-30	U-3461	Drug product	2022-11-02
N214628-002	10420735	2038-01-30	U-3461	Drug product	2022-11-02
N214628-002	10568850	2038-01-30		Drug product	2022-11-02
N214628-002	11413259	2038-01-30	U-3461	Drug product	2022-11-02
N214628-002	11602508	2038-01-30		Drug product	2023-03-14
N214628-002	12245996	2038-01-30		Drug product	2025-03-26
N214628-003	10159657	2038-01-30		Drug product	2022-11-02
N214628-003	10226436	2038-01-30	U-3461	Drug product	2022-11-02
N214628-003	10420735	2038-01-30	U-3461	Drug product	2022-11-02
N214628-003	10568850	2038-01-30		Drug product	2022-11-02
N214628-003	11413259	2038-01-30	U-3461	Drug product	2022-11-02
N214628-003	11602508	2038-01-30		Drug product	2023-03-14
N214628-003	12245996	2038-01-30		Drug product	2025-03-26

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 · 75 observed 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	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 456 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214628-001	10159657	2038-01-30		Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-001	10226436	2038-01-30	U-3461	Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-001	10420735	2038-01-30	U-3461	Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-001	10568850	2038-01-30		Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-001	11413259	2038-01-30	U-3461	Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-001	11602508	2038-01-30		Drug product	2023-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-001	12245996	2038-01-30		Drug product	2025-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-002	10159657	2038-01-30		Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-002	10226436	2038-01-30	U-3461	Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-002	10420735	2038-01-30	U-3461	Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-002	10568850	2038-01-30		Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-002	11413259	2038-01-30	U-3461	Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-002	11602508	2038-01-30		Drug product	2023-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-002	12245996	2038-01-30		Drug product	2025-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-003	10159657	2038-01-30		Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-003	10226436	2038-01-30	U-3461	Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-003	10420735	2038-01-30	U-3461	Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-003	10568850	2038-01-30		Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-003	11413259	2038-01-30	U-3461	Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-003	11602508	2038-01-30		Drug product	2023-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214628-003	12245996	2038-01-30		Drug product	2025-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-001	10159657	2038-01-30		Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-001	10226436	2038-01-30	U-3461	Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-001	10420735	2038-01-30	U-3461	Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-001	10568850	2038-01-30		Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-001	11413259	2038-01-30	U-3461	Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-001	11602508	2038-01-30		Drug product	2023-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-001	12245996	2038-01-30		Drug product	2025-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-002	10159657	2038-01-30		Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-002	10226436	2038-01-30	U-3461	Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-002	10420735	2038-01-30	U-3461	Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-002	10568850	2038-01-30		Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-002	11413259	2038-01-30	U-3461	Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-002	11602508	2038-01-30		Drug product	2023-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-002	12245996	2038-01-30		Drug product	2025-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-003	10159657	2038-01-30		Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-003	10226436	2038-01-30	U-3461	Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-003	10420735	2038-01-30	U-3461	Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-003	10568850	2038-01-30		Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214628-003	11413259	2038-01-30	U-3461	Drug product	2022-11-02	`31067a03dcf5…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ab36713-99a4-1d04-c42f-907afc73b6f9	Product name	7	20260105
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
209a4db0-2639-413d-9ad3-274ad7be11f7	Product name	1	20230912
08ddeef6-6d79-428b-a00b-432b50fc2b32	Product name	1	20230831
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42023-245-10	2024-01-30	C162847	48780-1	1030e365-647a-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION. NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION, for intravenous use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42023-245-10	NOREPINEPHRINE BITARTRATE	10 in 1 CARTON	INJECTION, SOLUTION	10		1
42023-245-10	NOREPINEPHRINE BITARTRATE	250 mL in 1 BAG	INJECTION, SOLUTION	250		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42023-245	NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE IN SODIUM CHLORIDE) INJECTION, SOLUTION NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE IN SODIUM CHLORIDE) INJECTION, SOLUTION NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE IN SODIUM CHLORIDE) INJECTION, SOLUTION [PAR PHARMACEUTICAL, INC.]	1	Legacy NDC, 2 package rows	20230105_1f112215-cef7-46a0-b838-ba0542a99d2c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norepinephrine	NOREPINEPHRINE BITARTRATE	Long Grove Pharmaceuticals, LLC	759807dd-61a8-4f6f-8bf5-f6ee773c81bc	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214628 application number: NDA214628

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
2619579	norepinephrine bitartrate 16 MG in 250 ML Injection	PSN	1f112215-cef7-46a0-b838-ba0542a99d2c	1
2475337	norepinephrine bitartrate 4 MG in 250 ML Injection	PSN	1f112215-cef7-46a0-b838-ba0542a99d2c	1
2475340	norepinephrine bitartrate 8 MG in 250 ML Injection	PSN	1f112215-cef7-46a0-b838-ba0542a99d2c	1
2475337	250 ML norepinephrine 0.016 MG/ML Injection	SCD	1f112215-cef7-46a0-b838-ba0542a99d2c	1
2475340	250 ML norepinephrine 0.032 MG/ML Injection	SCD	1f112215-cef7-46a0-b838-ba0542a99d2c	1
2619579	250 ML norepinephrine 0.064 MG/ML Injection	SCD	1f112215-cef7-46a0-b838-ba0542a99d2c	1
2619579	norepinephrine (as bitartrate) 16 MG per 250 ML Injection	SY	1f112215-cef7-46a0-b838-ba0542a99d2c	1
2475337	norepinephrine (as bitartrate) 4 MG per 250 ML Injection	SY	1f112215-cef7-46a0-b838-ba0542a99d2c	1
2475340	norepinephrine (as bitartrate) 8 MG per 250 ML Injection	SY	1f112215-cef7-46a0-b838-ba0542a99d2c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42023-245-10	42023024510	10 BAG in 1 CARTON (42023-245-10) > 250 mL in 1 BAG	10 bag	2023-01-04	0000-00-00	No	No	Current