NDC Compounded Drug 71285-0112-1 Sodium Chloride; Sodium Gluconate; Magnesium Chloride; Sodium Acetate; Potassium Chloride; Mannitol; Magnesium Sulfate Heptahydrate; Tromethamine; Dextrose Monohydrate
Solution Intracoronary
Compounded Drug Product Information
Frequently Asked Questions
What is the NDC number assigned to Maintenance 4 To1 Low K (40 Meq) In Plasmalyte A, Ph 7.4 With Tromethamine?
Maintenance 4 To1 Low K (40 Meq) In Plasmalyte A, Ph 7.4 With Tromethamine was assigned by its manufacturer with NDC product code 71285-0112. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.
Which are the NDC package codes for Maintenance 4 To1 Low K (40 Meq) In Plasmalyte A, Ph 7.4 With Tromethamine?
The NDC package code 71285-0112-1 was assigned to a 1000 mL in 1 BAG of sodium chloride; sodium gluconate; magnesium chloride; sodium acetate; potassium chloride; mannitol; magnesium sulfate heptahydrate; tromethamine; dextrose monohydrate administered intracoronary via solution.
Who manufactures this product?
Maintenance 4 To1 Low K (40 Meq) In Plasmalyte A, Ph 7.4 With Tromethamine is manufactured by an outsourced facility and labeled by Central Admixture Pharmacy Services, Inc.. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.