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Phenylephrine hydrochloride

These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE INJECTION.PHENYLEPHRINE HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 1954

Approved
Approval ID

4cea0781-2513-4030-8568-62dec253f866

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 29, 2023

Manufacturers
FDA

Lifestar Pharma LLC

DUNS: 080268943

Products 3

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

phenylephrine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70756-622
Application NumberANDA217069
Product Classification
M
Marketing Category
C73584
G
Generic Name
phenylephrine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 29, 2023
FDA Product Classification

INGREDIENTS (8)

PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 50 mg in 5 mL
Code: 04JA59TNSJ
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

phenylephrine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70756-623
Application NumberANDA217069
Product Classification
M
Marketing Category
C73584
G
Generic Name
phenylephrine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 29, 2023
FDA Product Classification

INGREDIENTS (8)

PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 100 mg in 10 mL
Code: 04JA59TNSJ
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

phenylephrine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70756-621
Application NumberANDA217069
Product Classification
M
Marketing Category
C73584
G
Generic Name
phenylephrine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 29, 2023
FDA Product Classification

INGREDIENTS (8)

PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT

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Phenylephrine hydrochloride - FDA Drug Approval Details