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

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 Identifiers#

Field, Values table
Field	Values
Unii	IFY5PE3ZRW
Rxcui	242969

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

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