NDC Compounded Drug 5446-0993-01 Cyclopentolate Hydrochloride; Phenylephrine Hydrochloride; Tropicamide; Ketorolac Tromethamine
Solution Ophthalmic
Compounded Drug Product Information
NDC Crossover Products Matching Cyclopentolate Hydrochloride; Phenylephrine Hydrochloride; Tropicamide; Ketorolac Tromethamine
NDC crossover of Phenylephrine 2.5% / Cyclopentolate 0.25% / Tropicamide 0.25% / Ketorolac 0.125% 1ml Syringe with NDC 5446-0993 a human compounded drug with other similar products matching the same substance name (Cyclopentolate Hydrochloride; Phenylephrine Hydrochloride; Tropicamide; Ketorolac Tromethamine) and the same administration route (ophthalmic) or dosage form (solution).
NDC | Proprietary Name | Non-Proprietary Name | Package Desc | Dosage Form | Route Name | Company Name |
---|---|---|---|---|---|---|
5446-0859-03 | Phenylephrine 10% / Cyclopentolate 0.25% / Tropicamide 0.25% / Ketorolac 0.125% 10ml Dropper | Phenylephrine, Cyclopentolate, Tropicamide, Ketorolac | 10 mL in 1 BOTTLE, DROPPER | Solution | Ophthalmic | Edge Pharma Llc |
Frequently Asked Questions
What is the NDC number assigned to Phenylephrine 10% / Cyclopentolate 0.25% / Tropicamide 0.25% / Ketorolac 0.125% 10ml Dropper?
Phenylephrine 10% / Cyclopentolate 0.25% / Tropicamide 0.25% / Ketorolac 0.125% 10ml Dropper was assigned by its manufacturer with NDC product code 5446-0993. 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 Phenylephrine 10% / Cyclopentolate 0.25% / Tropicamide 0.25% / Ketorolac 0.125% 10ml Dropper?
The NDC package code 5446-0993-01 was assigned to a 1 mL in 1 SYRINGE, PLASTIC of cyclopentolate hydrochloride; phenylephrine hydrochloride; tropicamide; ketorolac tromethamine administered ophthalmic via solution.
Who manufactures this product?
Phenylephrine 10% / Cyclopentolate 0.25% / Tropicamide 0.25% / Ketorolac 0.125% 10ml Dropper 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.
Which are the NDC crossover matchings for this product?
We found 1 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Edge Pharma LLC with NDC product codes 5446-0859-03.