Application 214313

Type: NDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NOREPINEPHRINE BITARTRATE;DEXTROSE	NOREPINEPHRINE BITARTRATE;DEXTROSE	INJECTABLE;INJECTION	16 MCG/ML	No	No
002	NOREPINEPHRINE BITARTRATE;DEXTROSE	NOREPINEPHRINE BITARTRATE;DEXTROSE	INJECTABLE;INJECTION	32 MCG/ML	Yes	No
003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	SOLUTION;INTRAVENOUS	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	Yes	Yes
004	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	SOLUTION;INTRAVENOUS	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	Yes	Yes
005	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	SOLUTION;INTRAVENOUS	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	Yes	Yes
006	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	SOLUTION;INTRAVENOUS	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 97 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
2026-08-18 06:07:40	2026-07	N214313-001	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214313-002	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214313-003	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2023-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214313-004	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2026-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214313-005	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2026-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214313-006	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2026-02-06	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N214313-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214313-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214313-003	AP	1	`caaa826d4ba7…`
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#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214313-001	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214313-001	12290494	2041-03-08		Drug product	2025-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214313-002	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214313-002	12290494	2041-03-08		Drug product	2025-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214313-003	12097170	2041-03-08	U-3995	Drug product	2024-09-30	`caaa826d4ba7…`
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…`

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): 0338-0112 ndc (product): 0338-0108

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0108	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	Baxter Healthcare Corporation	NDA	Current
0338-0108	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	Baxter Healthcare Corporation	NDA	Current
0338-0108	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	Baxter Healthcare Corporation	NDA	Current
0338-0108	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	Baxter Healthcare Corporation	NDA	Current
0338-0108	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	Baxter Healthcare Corporation	NDA	Current
0338-0108	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	Baxter Healthcare Corporation	NDA	Current
0338-0112	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	Baxter Healthcare Corporation	NDA	Current
0338-0112	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	Baxter Healthcare Corporation	NDA	Current
0338-0112	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	Baxter Healthcare Corporation	NDA	Current
0338-0112	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	Baxter Healthcare Corporation	NDA	Current
0338-0112	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	Baxter Healthcare Corporation	NDA	Current
0338-0112	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84997	SUPPL	2026-02-11
84970	SUPPL	2026-02-09
80176	SUPPL	2024-11-07
80014	SUPPL	2024-10-28
78981	SUPPL	2024-07-05
71848	SUPPL	2022-08-19
71840	SUPPL	2022-08-18
68094	ORIG	2021-07-15
65935	ORIG	2021-01-19
65914	ORIG	2021-01-15