NOREPINEPHRINE BITARTRATE
These highlights do not include all the information needed to use NOREPINEPHRINE BITARTRATE INJECTION safely and effectively. See full prescribing information for NOREPINEPHRINE BITARTRATE INJECTION. NOREPINEPHRINE BITARTRATE injection, for intravenous use Initial U.S. Approval: 1950
Approved
Approval ID
2ffda6e7-d45d-4af3-a3b1-250a4c95e736
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 20, 2023
Manufacturers
FDA
Caplin Steriles Limited
DUNS: 650744670
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 Code65145-133
Application NumberANDA217575
Product Classification
M
Marketing Category
C73584
G
Generic Name
norepinephrine bitartrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 20, 2023
FDA Product Classification
INGREDIENTS (3)
NOREPINEPHRINE BITARTRATEActive
Quantity: 1 mg in 1 mL
Code: IFY5PE3ZRW
Classification: ACTIM
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT