Norepinephrine Bitartrate

Product NDC: 25021-316
11-digit product format: 250210316
Labeler code: 25021
Product ID: 25021-316_61b38873-cf8d-48b6-b126-2e0a32ac5f7a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norepinephrine Bitartrate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA214323
Marketing category: ANDA
Marketing start: 2021-07-01
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
A214323-001	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2021-05-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214323-001	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	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214323-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2021-05-06	`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	A214323-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214323-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214323-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214323-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214323-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214323-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214323-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214323-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214323-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214323-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214323-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214323-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214323-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214323-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214323-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214323-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214323-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214323-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214323-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214323-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214323-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214323-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214323-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214323-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214323-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214323-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214323-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214323-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214323-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214323-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214323-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214323-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214323-001	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norepinephrine bitartrate	NOREPINEPHRINE BITARTRATE	Gland Pharma Limited	dec04acd-8e66-43c7-80b0-468802eba093	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214323 application number: ANDA214323
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	Sagent Pharmaceuticals	cc9ecec5-3bd7-4132-9745-7666bac8ceac	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214323 application number: ANDA214323 ndc (product): 25021-316
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	Baxter Healthcare Company	e375a0b9-4d26-4749-bbc3-43d63a7cf65a	2021-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214323 application number: ANDA214323

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
cc9ecec5-3bd7-4132-9745-7666bac8ceac	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
25021-316-04	Norepinephrine Bitartrate	4 mL in 1 VIAL	INJECTION, SOLUTION	4		3
25021-316-04	Norepinephrine Bitartrate	10 in 1 CARTON	INJECTION, SOLUTION	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-316-04	ML - Milliliter	25021-316	3ef407d1-2bd8-4ccb-b48a-edad305f5729	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-316	NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	3	Current NDC, Legacy NDC, 2 package rows	20241102_cc9ecec5-3bd7-4132-9745-7666bac8ceac.zip

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	cc9ecec5-3bd7-4132-9745-7666bac8ceac	3
242969	4 ML norepinephrine 1 MG/ML Injection	SCD	cc9ecec5-3bd7-4132-9745-7666bac8ceac	3
242969	norepinephrine (as bitartrate) 4 MG per 4 ML Injection	SY	cc9ecec5-3bd7-4132-9745-7666bac8ceac	3
242969	norepinephrine 4 MG per 4 ML Injection	SY	cc9ecec5-3bd7-4132-9745-7666bac8ceac	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-316-04	25021031604	10 VIAL in 1 CARTON (25021-316-04) / 4 mL in 1 VIAL	10 vial	2021-07-01	0000-00-00	No	No	Current