LABETALOL HCL injection, solution

Labetalol HCl by

Drug Labeling and Warnings

Labetalol HCl by is a Prescription medication manufactured, distributed, or labeled by Cantrell Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Label

SPL UNCLASSIFIED SECTION

INGREDIENTS AND APPEARANCE

LABETALOL HCL 
labetalol hcl injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52533-034
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95)	LABETALOL HYDROCHLORIDE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Anhydrous Dextrose (UNII: 5SL0G7R0OK)	45 mg  in 1 mL
Edetate Disodium (UNII: 7FLD91C86K)	0.1 mg  in 1 mL
Methylparaben (UNII: A2I8C7HI9T)	0.8 mg  in 1 mL
Propylparaben (UNII: Z8IX2SC1OH)	0.1 mg  in 1 mL
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52533-034-20	4 mL in 1 SYRINGE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/23/2012

Labeler - Cantrell Drug Company (035545763)