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.

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Oxytocin 20 USP Units Added to 5% Dextrose/Lactated Ringer's 1,000 mL Bag

Label

OXYTOCIN 
oxytocin injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-105
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN) OXYTOCIN2 [USP'U]  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X) 600 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) 310 mg  in 100 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) 30 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 20 mg  in 100 mL
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) 5 g  in 100 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:52533-105-441000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/12/2012
Labeler - Cantrell Drug Company (035545763)

Revised: 12/2014
Document Id: 5219e93f-e249-44ee-b692-92f3e76b3d26
Set id: 48d3f634-c7f4-48d4-895a-9ef77456cf49
Version: 3
Effective Time: 20141211
 
Cantrell Drug Company