LABETALOL HCL - labetalol hydrochloride injection, solution 
Cantrell Drug Company

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Labetalol HCl 5 mg/mL 4 mL Syringe

Label

Label

LABETALOL HCL 
labetalol hcl injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-034
Route of Administration INTRAVENOUS DEA Schedule     
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)

Revised: 5/2014
Document Id: dc956ab6-b338-4b27-8ae3-050bc5a7aef0
Set id: f0a9df5b-45b5-4be5-aeb6-76d0c27a7799
Version: 5
Effective Time: 20140502
 
Cantrell Drug Company