OXYTOCIN INJECTION, SOLUTION [CANTRELL DRUG COMPANY]

OXYTOCIN INJECTION, SOLUTION [CANTRELL DRUG COMPANY]
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NDC	52533-105-44
Set ID	48d3f634-c7f4-48d4-895a-9ef77456cf49
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	Cantrell Drug Company
Generic Name
Product Class
Product Number
Application Number

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PRINCIPAL DISPLAY PANEL
SPL UNCLASSIFIED SECTION

INGREDIENTS AND APPEARANCE

OXYTOCIN
oxytocin injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:52533-105
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN)	OXYTOCIN	2 [USP'U] in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
May contain	ACETIC ACID (UNII: Q40Q9N063P)
May contain	SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52533-105-44	1000 mL in 1 BAG

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/12/2012

Labeler - Cantrell Drug Company (035545763)

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