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Neo-Synephrine Hydrochloride

Neo-Synephrine HCl

Approved
Approval ID

120aa498-4834-4855-b74c-a02a93d5cf7f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 13, 2021

Manufacturers
FDA

Hospira, Inc.

DUNS: 141588017

Products 1

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 Code0409-1800
Product Classification
G
Generic Name
phenylephrine hydrochloride
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 13, 2021
FDA Product Classification

INGREDIENTS (5)

PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Quantity: 1 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 3.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 4 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT

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Neo-Synephrine Hydrochloride - FDA Drug Approval Details