MedPath

Norepinephrine bitartrate

These highlights do not include all the information needed to use safely and effectively. See full prescribing information for .  Initial U.S. Approval: 1950

Approved
Approval ID

d3ea12e0-88cc-49b0-b06e-5199ecd6ca69

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 15, 2021

Manufacturers
FDA

Mylan Institutional LLC

DUNS: 790384502

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Norepinephrine bitartrate

PRODUCT DETAILS

NDC Product Code67457-852
Application NumberANDA211242
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateOctober 22, 2018
Generic NameNorepinephrine bitartrate

INGREDIENTS (3)

NOREPINEPHRINE BITARTRATEActive
Quantity: 1 mg in 1 mL
Code: IFY5PE3ZRW
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Norepinephrine bitartrate - FDA Drug Approval Details