NDC 0517-3900-25 Calcium Gluconate

Calcium Gluconate

NDC Package Code 0517-3900-25

The NDC Code 0517-3900-25 is assigned to a package of 25 vial, pharmacy bulk package in 1 tray > 100 ml in 1 vial, pharmacy bulk package of Calcium Gluconate, a human prescription drug labeled by American Regent, Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

Field Name Field Value
NDC Code 0517-3900-25
Package Description 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
Proprietary Name Calcium Gluconate 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.
Non-Proprietary Name Calcium Gluconate 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.
11-Digit NDC Billing Format 00517390025 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.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type Human Prescription Drug 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.
Labeler Name American Regent, Inc.
Dosage Form Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s)
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
  • CALCIUM GLUCONATE MONOHYDRATE 98 mg/mL
Pharmacological Class(es)
  • Calcium - [CS]
  • Calcium - [EPC] (Established Pharmacologic Class)
  • Phosphate Binder - [EPC] (Established Pharmacologic Class)
  • Phosphate Chelating Activity - [MoA] (Mechanism of Action)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Start Marketing Date 12-01-1992 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

NDC Code Structure

  • 0517 - American Regent, Inc.
    • 0517-3900 - Calcium Gluconate
      • 0517-3900-25 - 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0517-3900-25 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
00517390025J0610Calcium gluconate injection10 ML1002510250

* Please review the disclaimer below.

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