NDC Compounded Drug 71285-9005-1 Monobasic Potassium Phosphate; Mannitol; Lidocaine Hydrochloride; Magnesium Sulfate Heptahydrate; Magnesium Chloride; Sodium Gluconate; Sodium Acetate; Potassium Chloride; Sodium Chloride; Sodium Bicarbonate; Sodium Phosphate, Dibasic, Heptahydrate
Solution Intracoronary
Compounded Drug Product Information
| NDC Product Code | 71285-9005 |
| NDC Package Code | 71285-9005-1 |
| 11-Digit NDC Billing Format NDC Format for Billing For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration. |
71285900501 |
| Package Description | 1052.8 mL in 1 BAG |
| Product Type What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing. |
Human Compounded Drug |
| Proprietary Name What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
Del Nido Isolyte-s |
| Non-Proprietary Name What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
Del Nido Isolyte-s |
| Substance Name What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted. |
Monobasic Potassium Phosphate; Mannitol; Lidocaine Hydrochloride; Magnesium Sulfate Heptahydrate; Magnesium Chloride; Sodium Gluconate; Sodium Acetate; Potassium Chloride; Sodium Chloride; Sodium Bicarbonate; Sodium Phosphate, Dibasic, Heptahydrate |
| Dosage Form | Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents. |
| Route Name | Intracoronary - Administration within the coronary arteries. |
| Marketing Category | OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) |
| Labeler Code | 71285 |
| Labeler Name What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC. |
Central Admixture Pharmacy Services, Inc. |
| Substance Name | Monobasic Potassium Phosphate; Mannitol; Lidocaine Hydrochloride; Magnesium Sulfate Heptahydrate; Magnesium Chloride; Sodium Gluconate; Sodium Acetate; Potassium Chloride; Sodium Chloride; Sodium Bicarbonate; Sodium Phosphate, Dibasic, Heptahydrate |
| Active Ingredients Information | 8 mg/1052.8 mL; 3.26 g/1052.8 mL; 126 mg/1052.8 mL; 2 g/1052.8 mL; .3 g/1052.8 mL; 4.94 g/1052.8 mL; 3.68 g/1052.8 mL; 2.304 g/1052.8 mL; 5.26 g/1052.8 mL; 1.094 g/1052.8 mL; 116 mg/1052.8 mL |
| Reporting Period | 2025-1 |
Frequently Asked Questions
What is the NDC number assigned to Del Nido Isolyte-s?
Del Nido Isolyte-s was assigned by its manufacturer with NDC product code 71285-9005. 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 Del Nido Isolyte-s?
The NDC package code 71285-9005-1 was assigned to a 1052.8 mL in 1 BAG of monobasic potassium phosphate; mannitol; lidocaine hydrochloride; magnesium sulfate heptahydrate; magnesium chloride; sodium gluconate; sodium acetate; potassium chloride; sodium chloride; sodium bicarbonate; sodium phosphate, dibasic, heptahydrate administered intracoronary via solution.
Who manufactures this product?
Del Nido Isolyte-s 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.
