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FDA Approval

labetalol hydrochloride

CompanySagent Pharmaceuticals (DUNS: 796852890)

Effective Date

April 12, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Labetalol(5 mg in 1 mL)

Products (1)

labetalol hydrochloride

NDC Product Code

25021-317

Application Number

ANDA214533

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

February 14, 2022

Ingredients

Anhydrous DextroseInactive

Code: 5SL0G7R0OKClass: IACT

MethylparabenInactive

Code: A2I8C7HI9TClass: IACT

Edetate DisodiumInactive

Code: 7FLD91C86KClass: IACT

Citric Acid MonohydrateInactive

Code: 2968PHW8QPClass: IACT

PropylparabenInactive

Code: Z8IX2SC1OHClass: IACT

Sodium HydroxideInactive

Code: 55X04QC32IClass: IACT

LabetalolActive

Code: 1GEV3BAW9JClass: ACTIBQuantity: 5 mg in 1 mL

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