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LEVOPHED

These highlights do not include all the information needed to use LEVOPHED safely and effectively. See full prescribing information for LEVOPHED. LEVOPHED (norepinephrine bitartrate) injection, for intravenous use Initial U.S. Approval: 1950

Approved
Approval ID

c4de72a8-2a75-4984-ce90-e4870226dc12

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 2, 2020

Manufacturers
FDA

Hospira, Inc.

DUNS: 141588017

Products 2

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 Code0409-3375
Application NumberNDA007513
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateOctober 31, 2020
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

NOREPINEPHRINE BITARTRATE

PRODUCT DETAILS

NDC Product Code0409-1443
Application NumberNDA007513
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateOctober 31, 2020
Generic NameNOREPINEPHRINE BITARTRATE

INGREDIENTS (3)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
NOREPINEPHRINE BITARTRATEActive
Quantity: 1 mg in 1 mL
Code: IFY5PE3ZRW
Classification: ACTIM
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
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LEVOPHED - FDA Approval | MedPath