Labetalol Hydrochloride
LABETALOL HYDROCHLORIDE INJECTION, USP Rx only
Approved
Approval ID
77152699-1ca8-442a-8cb4-80b0ffbec6f2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2021
Manufacturers
FDA
Caplin Steriles Limited
DUNS: 650744670
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Labetalol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65145-124
Application NumberANDA214533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Labetalol Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 15, 2021
FDA Product Classification
INGREDIENTS (7)
METHYLPARABENInactive
Quantity: 0.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
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
PROPYLPARABENInactive
Quantity: 0.1 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Labetalol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65145-125
Application NumberANDA214533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Labetalol Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 15, 2021
FDA Product Classification
INGREDIENTS (7)
LABETALOL HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 1GEV3BAW9J
Classification: ACTIB
PROPYLPARABENInactive
Quantity: 0.1 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Quantity: 0.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ANHYDROUS DEXTROSEInactive
Quantity: 45 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT