NDC Compounded Drug 5446-1189-01 Tetracaine; Tropicamide; Phenylephrine Hydrochloride; Ketorolac Tromethamine
Solution Ophthalmic
Compounded Drug Product Information
Frequently Asked Questions
What is the NDC number assigned to Phenylpherine 2.5% / Tropicamide 1% / Ketoloralac 0.125% / Tetracaine 0.5%?
Phenylpherine 2.5% / Tropicamide 1% / Ketoloralac 0.125% / Tetracaine 0.5% was assigned by its manufacturer with NDC product code 5446-1189. 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 Phenylpherine 2.5% / Tropicamide 1% / Ketoloralac 0.125% / Tetracaine 0.5%?
The NDC package code 5446-1189-01 was assigned to a .5 mL in 1 SYRINGE, PLASTIC of tetracaine; tropicamide; phenylephrine hydrochloride; ketorolac tromethamine administered ophthalmic via solution.
Who manufactures this product?
Phenylpherine 2.5% / Tropicamide 1% / Ketoloralac 0.125% / Tetracaine 0.5% is manufactured by an outsourced facility and labeled by Edge Pharma Llc. 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.