NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE

Product NDC: 44567-643
11-digit product format: 445670643
Labeler code: 44567
Product ID: 44567-643_a0cf3162-9ed3-4774-a076-fc8af5bbe3d0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NOREPINEPHRINE BITARTRATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: WG Critical Care, LLC
Application: NDA215700
Marketing category: NDA
Marketing start: 2022-09-15
Substance: NOREPINEPHRINE BITARTRATE
Active strength: .128 mg/mL
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15
N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15
N215700-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15
N215700-004	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	EQ 32MG BASE/250ML (EQ 128MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-10-15

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N215700-001	RE49422	2035-02-26	Drug product	2025-03-03
N215700-001	10888534	2039-04-26	Drug product	2022-09-21
N215700-002	RE49422	2035-02-26	Drug product	2025-03-03
N215700-002	10888534	2039-04-26	Drug product	2022-09-21
N215700-003	RE49422	2035-02-26	Drug product	2025-03-03
N215700-003	RE49443	2035-02-26	Drug product	2025-03-03
N215700-003	10888534	2039-04-26	Drug product	2022-09-21
N215700-004	RE49422	2035-02-26	Drug product	2026-01-22
N215700-004	RE49443	2035-02-26	Drug product	2026-01-22
N215700-004	10888534	2039-04-26	Drug product	2026-01-22

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 · 81 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	N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215700-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215700-004	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 32MG BASE/250ML (EQ 128MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215700-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215700-004	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 32MG BASE/250ML (EQ 128MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215700-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215700-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215700-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215700-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215700-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215700-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215700-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215700-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215700-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215700-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215700-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215700-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-15	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 103 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215700-001	RE49422	2035-02-26	Drug product	2025-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215700-001	10888534	2039-04-26	Drug product	2022-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215700-002	RE49422	2035-02-26	Drug product	2025-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215700-002	10888534	2039-04-26	Drug product	2022-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215700-003	10251848	2035-02-26	Drug product	2025-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215700-003	RE49422	2035-02-26	Drug product	2025-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215700-003	RE49443	2035-02-26	Drug product	2025-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215700-003	10888534	2039-04-26	Drug product	2022-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215700-004	RE49422	2035-02-26	Drug product	2026-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215700-004	RE49443	2035-02-26	Drug product	2026-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215700-004	10888534	2039-04-26	Drug product	2026-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215700-001	RE49422	2035-02-26	Drug product	2025-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215700-001	10888534	2039-04-26	Drug product	2022-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215700-002	RE49422	2035-02-26	Drug product	2025-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215700-002	10888534	2039-04-26	Drug product	2022-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215700-003	10251848	2035-02-26	Drug product	2025-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215700-003	RE49422	2035-02-26	Drug product	2025-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215700-003	RE49443	2035-02-26	Drug product	2025-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215700-003	10888534	2039-04-26	Drug product	2022-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215700-001	RE49422	2035-02-26	Drug product	2025-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215700-001	10888534	2039-04-26	Drug product	2022-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215700-002	RE49422	2035-02-26	Drug product	2025-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215700-002	10888534	2039-04-26	Drug product	2022-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215700-003	10251848	2035-02-26	Drug product	2025-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215700-003	RE49422	2035-02-26	Drug product	2025-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215700-003	RE49443	2035-02-26	Drug product	2025-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215700-003	10888534	2039-04-26	Drug product	2022-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215700-001	10888534	2039-04-26	Drug product	2022-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215700-002	10888534	2039-04-26	Drug product	2022-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215700-003	10888534	2039-04-26	Drug product	2022-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215700-001	10888534	2039-04-26	Drug product	2022-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215700-002	10888534	2039-04-26	Drug product	2022-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215700-003	10888534	2039-04-26	Drug product	2022-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215700-001	10888534	2039-04-26	Drug product	2022-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215700-002	10888534	2039-04-26	Drug product	2022-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215700-003	10888534	2039-04-26	Drug product	2022-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215700-001	10888534	2039-04-26	Drug product	2022-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215700-002	10888534	2039-04-26	Drug product	2022-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215700-003	10888534	2039-04-26	Drug product	2022-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215700-001	10888534	2039-04-26	Drug product	2022-09-21	`5bbf6a4d5a75…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NOREPINEPHRINE BITARTRATE	.128 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2475337	Internal RxNorm lookup
2475340	Internal RxNorm lookup
2619579	Internal RxNorm lookup
2725614	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
ddbef60d-c20a-4ada-928f-e87074c08a54	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
44567-643-01	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE	250 mL in 1 BAG	INJECTION, SOLUTION	250		10
44567-643-10	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE	10 in 1 CARTON	INJECTION, SOLUTION	10		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44567-643-01	ML - Milliliter	44567-643	3f7e32ea-dc95-48f7-8f3c-9be3cbe2e6b0	1	2025-12-16
44567-643-10	ML - Milliliter	44567-643	a6bab38d-9fae-457e-8793-cc0b842f16a9	1	2025-12-16

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 IN SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	WG Critical Care, LLC	ddbef60d-c20a-4ada-928f-e87074c08a54	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215700 application number: NDA215700 ndc (product): 44567-643

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	ddbef60d-c20a-4ada-928f-e87074c08a54	10
2725614	norepinephrine bitartrate 32 MG in 250 ML Injection	PSN	ddbef60d-c20a-4ada-928f-e87074c08a54	10
2475337	norepinephrine bitartrate 4 MG in 250 ML Injection	PSN	ddbef60d-c20a-4ada-928f-e87074c08a54	10
2475340	norepinephrine bitartrate 8 MG in 250 ML Injection	PSN	ddbef60d-c20a-4ada-928f-e87074c08a54	10
2475337	250 ML norepinephrine 0.016 MG/ML Injection	SCD	ddbef60d-c20a-4ada-928f-e87074c08a54	10
2475340	250 ML norepinephrine 0.032 MG/ML Injection	SCD	ddbef60d-c20a-4ada-928f-e87074c08a54	10
2619579	250 ML norepinephrine 0.064 MG/ML Injection	SCD	ddbef60d-c20a-4ada-928f-e87074c08a54	10
2725614	250 ML norepinephrine 0.128 MG/ML Injection	SCD	ddbef60d-c20a-4ada-928f-e87074c08a54	10
2619579	norepinephrine (as bitartrate) 16 MG per 250 ML Injection	SY	ddbef60d-c20a-4ada-928f-e87074c08a54	10
2725614	norepinephrine (as bitartrate) 32 MG per 250 ML Injection	SY	ddbef60d-c20a-4ada-928f-e87074c08a54	10
2475337	norepinephrine (as bitartrate) 4 MG per 250 ML Injection	SY	ddbef60d-c20a-4ada-928f-e87074c08a54	10
2475340	norepinephrine (as bitartrate) 8 MG per 250 ML Injection	SY	ddbef60d-c20a-4ada-928f-e87074c08a54	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
44567-643-01	44567064301	250 mL in 1 BAG	250 ml				Historical
44567-643-10	44567064310	10 BAG in 1 CARTON (44567-643-10) / 250 mL in 1 BAG (44567-643-01)	10 bag	2025-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE	WG Critical Care, LLC \| Inforlife SA	2026-02-17	HUMAN PRESCRIPTION DRUG LABEL	10