Norepinephrine bitartrate

Product NDC: 72078-002
11-digit product format: 720780002
Labeler code: 72078
Product ID: 72078-002_f55bd465-c5b2-4542-8765-00480fd6043d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norepinephrine bitartrate
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Mylan Institutional LLC
Application: ANDA211242
Marketing category: ANDA
Marketing start: 2020-12-04
Marketing end: 0000-00-00
Substance: NOREPINEPHRINE BITARTRATE
Active strength: 1 mg/mL
Pharmacologic classes: Catecholamine [EPC],Catecholamines [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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
A211242-001	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2018-10-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211242-001	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.

Product history page 1 of 2 · 41 observed 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	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211242-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2018-10-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211242-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211242-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211242-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211242-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211242-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211242-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211242-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211242-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211242-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211242-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211242-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211242-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211242-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211242-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211242-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211242-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211242-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211242-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211242-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211242-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211242-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211242-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211242-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211242-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211242-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211242-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211242-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211242-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211242-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211242-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211242-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211242-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211242-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211242-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211242-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211242-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211242-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211242-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211242-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211242-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Norepinephrine bitartrate

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
7a4950ea-6369-4dd5-97be-df21a5a5055f	Available on FDA.report

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72078-002-00	ML - Milliliter	72078-002	6b6c2614-a27d-405e-867e-c1a88bdec23d	1	2021-01-08
72078-002-04	ML - Milliliter	72078-002	4b343ddb-7996-47be-9490-7936732b3f61	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72078-002	NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC]	2	Legacy NDC	20210327_7a4950ea-6369-4dd5-97be-df21a5a5055f.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	Mylan Institutional LLC	d3ea12e0-88cc-49b0-b06e-5199ecd6ca69	2021-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211242 application number: ANDA211242
Norepinephrine bitartrate	NOREPINEPHRINE BITARTRATE	Mylan Institutional LLC	7a4950ea-6369-4dd5-97be-df21a5a5055f	2021-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211242 application number: ANDA211242 ndc (product): 72078-002

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IFY5PE3ZRW	NOREPINEPHRINE BITARTRATE	108341-18-0	NOREPINEPHRINE BITARTRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72078-002-04	72078000204	10 VIAL, SINGLE-DOSE in 1 CARTON (72078-002-04) > 4 mL in 1 VIAL, SINGLE-DOSE (72078-002-00)	2020-12-04	0000-00-00	No	No	Current