Phenylephrine hydrochloride
These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE 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
e1d3881f-fa9e-4d68-8ef0-9e03435fc292
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
Provepharm Inc.
DUNS: 086861066
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 Code81284-213
Application NumberANDA211081
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenylephrine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 17, 2021
FDA Product Classification
INGREDIENTS (8)
SODIUM CHLORIDEInactive
Quantity: 3.50 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 4.00 mg in 1 mL
Code: B22547B95K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Quantity: 1.00 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 2.00 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Phenylephrine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81284-212
Application NumberANDA211081
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenylephrine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 17, 2021
FDA Product Classification
INGREDIENTS (8)
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 3.50 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 1.00 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 2.00 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 4.00 mg in 1 mL
Code: B22547B95K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Phenylephrine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81284-211
Application NumberANDA211081
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenylephrine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 17, 2021
FDA Product Classification
INGREDIENTS (8)
SODIUM METABISULFITEInactive
Quantity: 2.00 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 3.50 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 4.00 mg in 1 mL
Code: B22547B95K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 1.00 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT