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FDA Approval

NOREPINEPHRINE BITARTRATE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
October 20, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Norepinephrine(16 mg in 250 mL)

Products3

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 Code
42023-247
Application Number
NDA214628
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
October 20, 2022
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 2.25 g in 250 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 2.5 mg in 250 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: IFY5PE3ZRWClass: ACTIMQuantity: 16 mg in 250 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT

NOREPINEPHRINE BITARTRATE

Product Details

NDC Product Code
42023-246
Application Number
NDA214628
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
October 20, 2022
Code: IFY5PE3ZRWClass: ACTIMQuantity: 8 mg in 250 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 2.5 mg in 250 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 2.25 g in 250 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

NOREPINEPHRINE BITARTRATE

Product Details

NDC Product Code
42023-245
Application Number
NDA214628
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
October 20, 2022
Code: IFY5PE3ZRWClass: ACTIMQuantity: 4 mg in 250 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 2.25 g in 250 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 2.5 mg in 250 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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