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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 use Initial U.S. Approval: 1954

Approved
Approval ID

5788f8c6-f868-4b83-81dc-dc485d8716c0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 17, 2022

Manufacturers
FDA

Sandoz Inc

DUNS: 005387188

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 Code0781-9228
Application NumberANDA208905
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenylephrine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 17, 2022
FDA Product Classification

INGREDIENTS (8)

SODIUM CHLORIDEInactive
Quantity: 3.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 4 mg in 1 mL
Code: B22547B95K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 1 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 2 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

Phenylephrine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0781-9227
Application NumberANDA208905
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenylephrine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 17, 2022
FDA Product Classification

INGREDIENTS (8)

CITRIC ACID MONOHYDRATEInactive
Quantity: 1 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 2 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 3.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 4 mg in 1 mL
Code: B22547B95K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB

Phenylephrine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0781-9226
Application NumberANDA208905
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenylephrine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 17, 2022
FDA Product Classification

INGREDIENTS (8)

SODIUM CHLORIDEInactive
Quantity: 3.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 4 mg in 1 mL
Code: B22547B95K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 1 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB
SODIUM METABISULFITEInactive
Quantity: 2 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

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Phenylephrine Hydrochloride - FDA Drug Approval Details