NOREPINEPHRINE BITARTRATE

Product NDC: 0338-0040
11-digit product format: 003380040
Labeler code: 0338
Product ID: 0338-0040_b40627c0-67bf-4740-9d21-83054aa6afd9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: norepinephrine bitartrate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA214313
Marketing category: NDA
Marketing start: 2023-11-21
Substance: NOREPINEPHRINE BITARTRATE
Active strength: 4 mg/250mL
Pharmacologic classes: Catecholamine [EPC], Catecholamines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-01-15
N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-01-15
N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2023-11-21
N214313-004	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2026-02-06
N214313-005	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2026-02-06
N214313-006	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2026-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N214313-001	AP
N214313-002	AP
N214313-003	AP

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214313-001	12097170	2041-03-08	U-3995	Drug product	2024-09-30
N214313-001	12290494	2041-03-08		Drug product	2025-05-16
N214313-002	12097170	2041-03-08	U-3995	Drug product	2024-09-30
N214313-002	12290494	2041-03-08		Drug product	2025-05-16
N214313-003	12097170	2041-03-08	U-3995	Drug product	2024-09-30

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 3 · 91 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214313-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214313-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214313-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214313-002	AP	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214313-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214313-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214313-003	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

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	N214313-001	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214313-001	12290494	2041-03-08		Drug product	2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214313-002	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214313-002	12290494	2041-03-08		Drug product	2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214313-003	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214313-001	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214313-001	12290494	2041-03-08		Drug product	2025-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214313-002	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214313-002	12290494	2041-03-08		Drug product	2025-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214313-003	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214313-001	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214313-001	12290494	2041-03-08		Drug product	2025-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214313-002	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214313-002	12290494	2041-03-08		Drug product	2025-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214313-003	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214313-001	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214313-002	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214313-003	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214313-001	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214313-002	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214313-003	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214313-001	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214313-002	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214313-003	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214313-001	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214313-002	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214313-003	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214313-001	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214313-002	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214313-003	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214313-001	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214313-002	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214313-003	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214313-001	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214313-001	12290494	2041-03-08		Drug product	2025-05-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214313-002	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214313-002	12290494	2041-03-08		Drug product	2025-05-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214313-003	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: NOREPINEPHRINE BITARTRATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NOREPINEPHRINE BITARTRATE	4 mg/250mL

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
6363e9b4-29df-4553-904d-a563e5adda6e	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-0040-20	NOREPINEPHRINE BITARTRATE	20 in 1 CARTON	INJECTION, SOLUTION	20		13
0338-0040-20	NOREPINEPHRINE BITARTRATE	250 mL in 1 BAG	INJECTION, SOLUTION	250		13

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 BITARTRATE	NOREPINEPHRINE BITARTRATE	Baxter Healthcare Corporation	6363e9b4-29df-4553-904d-a563e5adda6e	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214313 application number: NDA214313 ndc (product): 0338-0040

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	6363e9b4-29df-4553-904d-a563e5adda6e	13
2475337	norepinephrine bitartrate 4 MG in 250 ML Injection	PSN	6363e9b4-29df-4553-904d-a563e5adda6e	13
2475340	norepinephrine bitartrate 8 MG in 250 ML Injection	PSN	6363e9b4-29df-4553-904d-a563e5adda6e	13
2475337	250 ML norepinephrine 0.016 MG/ML Injection	SCD	6363e9b4-29df-4553-904d-a563e5adda6e	13
2475340	250 ML norepinephrine 0.032 MG/ML Injection	SCD	6363e9b4-29df-4553-904d-a563e5adda6e	13
2619579	250 ML norepinephrine 0.064 MG/ML Injection	SCD	6363e9b4-29df-4553-904d-a563e5adda6e	13
2619579	norepinephrine (as bitartrate) 16 MG per 250 ML Injection	SY	6363e9b4-29df-4553-904d-a563e5adda6e	13
2475337	norepinephrine (as bitartrate) 4 MG per 250 ML Injection	SY	6363e9b4-29df-4553-904d-a563e5adda6e	13
2475340	norepinephrine (as bitartrate) 8 MG per 250 ML Injection	SY	6363e9b4-29df-4553-904d-a563e5adda6e	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0338-0040-20	00338004020	20 BAG in 1 CARTON (0338-0040-20) / 250 mL in 1 BAG	20 bag	2026-02-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NOREPINEPHRINE BITARTRATE	Baxter Healthcare Corporation	2026-02-06	HUMAN PRESCRIPTION DRUG LABEL	13