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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
Lifestar Pharma LLC
DUNS: 080268943
Effective Date
March 29, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Phenylephrine(50 mg in 5 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Mankind Pharma Limited

915834068

Manufacturing Establishments1

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

Mankind Pharma Limited

Lifestar Pharma LLC

Mankind Pharma Limited

916512493

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
70756-622
Application Number
ANDA217069
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
March 29, 2023
PhenylephrineActive
Code: 04JA59TNSJClass: ACTIBQuantity: 50 mg in 5 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT

Phenylephrine hydrochloride

Product Details

NDC Product Code
70756-623
Application Number
ANDA217069
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
March 29, 2023
PhenylephrineActive
Code: 04JA59TNSJClass: ACTIBQuantity: 100 mg in 10 mL
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

Phenylephrine hydrochloride

Product Details

NDC Product Code
70756-621
Application Number
ANDA217069
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
March 29, 2023
PhenylephrineActive
Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
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