Labetalol Hydrochloride
Labetalol Hydrochloride
Approved
Approval ID
d3579d45-a964-40fe-e3a2-a3a997c8b7b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 28, 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.
Labetalol Hydrochloride
PRODUCT DETAILS
NDC Product Code0409-2339
Application NumberANDA075239
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 28, 2021
Generic NameLabetalol Hydrochloride
INGREDIENTS (7)
LABETALOL HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 1GEV3BAW9J
Classification: ACTIB
ANHYDROUS DEXTROSEInactive
Quantity: 45 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
METHYLPARABENInactive
Quantity: 0.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.1 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT