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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

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NOREPINEPHRINE BITARTRATE - FDA Drug Approval Details