Labetalol Hydrochloride
LABETALOL HYDROCHLORIDE INJECTION, USP
Approved
Approval ID
5b059ef2-dec0-4cea-b8df-d87df3fea9e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2018
Manufacturers
FDA
West-Ward Pharmaceuticals Corp
DUNS: 001230762
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9320
Application NumberANDA075303
Product Classification
M
Marketing Category
C73584
G
Generic Name
Labetalol Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS DEXTROSEInactive
Quantity: 45 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT
LABETALOL HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 1GEV3BAW9J
Classification: ACTIB
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
PROPYLPARABENInactive
Quantity: 0.1 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT