Norepinephrine Bitartrate

Product NDC: 63323-940
11-digit product format: 633230940
Labeler code: 63323
Product ID: 63323-940_c7fb762a-d42e-44a1-9c3a-af503aa96fb5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NOREPINEPHRINE BITARTRATE
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA211382
Marketing category: ANDA
Marketing start: 2021-03-01
Substance: NOREPINEPHRINE BITARTRATE
Active strength: 1 mg/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211382-001	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2020-11-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211382-001	AP

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211382-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-03	`a50c72e98297…`

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	A211382-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211382-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211382-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211382-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211382-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211382-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211382-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211382-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211382-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211382-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211382-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211382-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211382-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211382-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211382-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211382-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211382-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211382-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211382-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211382-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211382-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211382-001	AP	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211382-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211382-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211382-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211382-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211382-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211382-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211382-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211382-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211382-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211382-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211382-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211382-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211382-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211382-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NOREPINEPHRINE BITARTRATE	1 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
242969	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
c297757e-35ff-4f39-bccd-61002ac51e23	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
63323-940-04	Norepinephrine Bitartrate	10 in 1 CARTON	SOLUTION	10		7
63323-940-21	Norepinephrine Bitartrate	4 mL in 1 VIAL, SINGLE-DOSE	SOLUTION	4		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-940-04	ML - Milliliter	63323-940	59261f8f-5f67-43aa-b02c-816c1de210cc	1	2021-08-05
63323-940-21	ML - Milliliter	63323-940	18b7db3e-f217-4335-9691-7ff33592c7db	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-940	NOREPINEPHRINE BITARTRATE SOLUTION [FRESENIUS KABI USA, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20210908_c297757e-35ff-4f39-bccd-61002ac51e23.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	dfed53ef-2060-44b8-a62e-9f8ee10a05a5	2023-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211382 application number: ANDA211382
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	c297757e-35ff-4f39-bccd-61002ac51e23	2020-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211382 application number: ANDA211382 ndc (product): 63323-940

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
242969	norepinephrine bitartrate 4 MG in 4 mL Injection	PSN	c297757e-35ff-4f39-bccd-61002ac51e23	7
242969	4 ML norepinephrine 1 MG/ML Injection	SCD	c297757e-35ff-4f39-bccd-61002ac51e23	7
242969	norepinephrine (as bitartrate) 4 MG per 4 ML Injection	SY	c297757e-35ff-4f39-bccd-61002ac51e23	7
242969	norepinephrine 4 MG per 4 ML Injection	SY	c297757e-35ff-4f39-bccd-61002ac51e23	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-940-04	63323094004	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-940-04) / 4 mL in 1 VIAL, SINGLE-DOSE (63323-940-21)		2021-03-01	0000-00-00	No	No	Current
63323-940-21	63323094021	4 mL in 1 VIAL, SINGLE-DOSE	4 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Norepinephrine Bitartrate	Fresenius Kabi USA, LLC \| Indoco Remedies Limited	2020-12-02	HUMAN PRESCRIPTION DRUG LABEL	7