OXYTOCIN - oxytocin 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.

----------

Oxytocin 30 USP Units Added to 5% Dextrose/Lactated Ringer's 500 mL Bag

Label

OXYTOCIN 
oxytocin injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-054
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN) OXYTOCIN30 [USP'U]  in 500 mL
Inactive Ingredients
Ingredient NameStrength
DEXTROSE (UNII: IY9XDZ35W2) 25 g  in 500 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 3 g  in 500 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) 1.55 g  in 500 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) 0.15 g  in 500 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 0.1 g  in 500 mL
Other Ingredients
Ingredient KindIngredient NameQuantity
May containACETIC ACID (UNII: Q40Q9N063P)  
May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52533-054-30500 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/20/2011
Labeler - Cantrell Drug Company (035545763)

Revised: 12/2014
Document Id: a7bd8a1a-594b-4c80-a4a0-0b720a728d53
Set id: d0c29c3a-4dc1-4c00-add9-3075318e74ca
Version: 2
Effective Time: 20141203
 
Cantrell Drug Company