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FDA Approval

Phenylephrine Hydrochloride

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

FDA Approval Summary

Company

DUNS: 005387188

Effective Date

October 17, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Phenylephrine(10 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Delpharm Boucherville Canada Inc.

Labeler

Sandoz Inc

DUNS Number

242254227

Products3

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

Phenylephrine Hydrochloride

Product Details

NDC Product Code

0781-9228

Application Number

ANDA208905

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

October 17, 2022

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 3.5 mg in 1 mL

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACTQuantity: 4 mg in 1 mL

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACTQuantity: 1 mg in 1 mL

SODIUM METABISULFITEInactive

Code: 4VON5FNS3CClass: IACTQuantity: 2 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

PhenylephrineActive

Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

Phenylephrine Hydrochloride

Product Details

NDC Product Code

0781-9227

Application Number

ANDA208905

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

October 17, 2022

Ingredients

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACTQuantity: 1 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3CClass: IACTQuantity: 2 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 3.5 mg in 1 mL

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACTQuantity: 4 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

PhenylephrineActive

Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 1 mL

Phenylephrine Hydrochloride

Product Details

NDC Product Code

0781-9226

Application Number

ANDA208905

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

October 17, 2022

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 3.5 mg in 1 mL

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACTQuantity: 4 mg in 1 mL

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACTQuantity: 1 mg in 1 mL

PhenylephrineActive

Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 1 mL

SODIUM METABISULFITEInactive

Code: 4VON5FNS3CClass: IACTQuantity: 2 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

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