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NOREPINEPHRINE BITARTRATE

These highlights do not include all the information needed to use NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION. NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION, for intravenous useInitial U.S. Approval: 1950

Approved
Approval ID

1f112215-cef7-46a0-b838-ba0542a99d2c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 20, 2022

Manufacturers
FDA

Par Pharmaceutical, Inc.

DUNS: 092733690

Products 3

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

Norepinephrine in Sodium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42023-247
Application NumberNDA214628
Product Classification
M
Marketing Category
C73594
G
Generic Name
Norepinephrine in Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 20, 2022
FDA Product Classification

INGREDIENTS (5)

SODIUM CHLORIDEInactive
Quantity: 2.25 g in 250 mL
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 2.5 mg in 250 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
NOREPINEPHRINE BITARTRATEActive
Quantity: 16 mg in 250 mL
Code: IFY5PE3ZRW
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

NOREPINEPHRINE in Sodium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42023-246
Application NumberNDA214628
Product Classification
M
Marketing Category
C73594
G
Generic Name
NOREPINEPHRINE in Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 20, 2022
FDA Product Classification

INGREDIENTS (5)

NOREPINEPHRINE BITARTRATEActive
Quantity: 8 mg in 250 mL
Code: IFY5PE3ZRW
Classification: ACTIM
EDETATE DISODIUMInactive
Quantity: 2.5 mg in 250 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 2.25 g in 250 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

NOREPINEPHRINE IN SODIUM CHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42023-245
Application NumberNDA214628
Product Classification
M
Marketing Category
C73594
G
Generic Name
NOREPINEPHRINE IN SODIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 20, 2022
FDA Product Classification

INGREDIENTS (5)

NOREPINEPHRINE BITARTRATEActive
Quantity: 4 mg in 250 mL
Code: IFY5PE3ZRW
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 2.25 g in 250 mL
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 2.5 mg in 250 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

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NOREPINEPHRINE BITARTRATE - FDA Drug Approval Details