Norepinephrine

Product NDC: 81298-9658
11-digit product format: 812989658
Labeler code: 81298
Product ID: 81298-9658_329c5273-4dc5-4738-bf21-660e73d91eb9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norepinephrine Bitartrate
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: Long Grove Pharmaceuticals, LLC
Application: NDA214628
Marketing category: NDA
Marketing start: 2024-02-02
Substance: NOREPINEPHRINE BITARTRATE
Active strength: 64 ug/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 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NOREPINEPHRINE BITARTRATE	64 ug/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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2475337	Internal RxNorm lookup
2475340	Internal RxNorm lookup
2619579	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
759807dd-61a8-4f6f-8bf5-f6ee773c81bc	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	SPL version
81298-9658-1	Norepinephrine	250 mL in 1 BAG	SOLUTION	250	2
81298-9658-1	Norepinephrine	1 in 1 POUCH	SOLUTION	1	2
81298-9658-3	Norepinephrine	10 in 1 BOX	SOLUTION	10	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81298-9658-1	ML - Milliliter	81298-9658	be5bd178-fd61-488f-ad19-b577fc316947	1	2024-06-10
81298-9658-3	ML - Milliliter	81298-9658	48b0933e-bb7e-4890-9064-814d008a279a	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81298-9658	NOREPINEPHRINE (NOREPINEPHRINE BITARTRATE) SOLUTION [LONG GROVE PHARMACEUTICALS, LLC]	1	Current NDC, 3 package rows	20240202_759807dd-61a8-4f6f-8bf5-f6ee773c81bc.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 ndc (product): 81298-9658

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	759807dd-61a8-4f6f-8bf5-f6ee773c81bc	2
2475337	norepinephrine bitartrate 4 MG in 250 ML Injection	PSN	759807dd-61a8-4f6f-8bf5-f6ee773c81bc	2
2475340	norepinephrine bitartrate 8 MG in 250 ML Injection	PSN	759807dd-61a8-4f6f-8bf5-f6ee773c81bc	2
2475337	250 ML norepinephrine 0.016 MG/ML Injection	SCD	759807dd-61a8-4f6f-8bf5-f6ee773c81bc	2
2475340	250 ML norepinephrine 0.032 MG/ML Injection	SCD	759807dd-61a8-4f6f-8bf5-f6ee773c81bc	2
2619579	250 ML norepinephrine 0.064 MG/ML Injection	SCD	759807dd-61a8-4f6f-8bf5-f6ee773c81bc	2
2619579	norepinephrine (as bitartrate) 16 MG per 250 ML Injection	SY	759807dd-61a8-4f6f-8bf5-f6ee773c81bc	2
2475337	norepinephrine (as bitartrate) 4 MG per 250 ML Injection	SY	759807dd-61a8-4f6f-8bf5-f6ee773c81bc	2
2475340	norepinephrine (as bitartrate) 8 MG per 250 ML Injection	SY	759807dd-61a8-4f6f-8bf5-f6ee773c81bc	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81298-9658-1	81298965801	250 mL in 1 BAG	250 ml				Historical
81298-9658-3	81298965803	10 POUCH in 1 BOX (81298-9658-3) / 1 BAG in 1 POUCH (81298-9658-1) / 250 mL in 1 BAG	10 pouch	2024-02-02	No	No	Current