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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-852
Application NumberANDA211242
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norepinephrine bitartrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 22, 2018
FDA Product Classification
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