NDC 0126-0072-92 Prevident 5000 Booster Plus Fruitastic

Sodium Fluoride

NDC Package Code 0126-0072-92

The NDC Code 0126-0072-92 is assigned to a package of 100 ml in 1 bottle, plastic of Prevident 5000 Booster Plus Fruitastic, a human prescription drug labeled by Colgate Oral Pharmaceuticals, Inc.. The product's dosage form is paste, dentifrice and is administered via dental form.

Field Name Field Value
NDC Code 0126-0072-92
Package Description 100 mL in 1 BOTTLE, PLASTIC
Proprietary Name Prevident 5000 Booster Plus Fruitastic 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 Sodium Fluoride 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 00126007292 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.
RxNorm Crosswalk392038 and 630194 - RxCUIs What is RxNorm?
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
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 Colgate Oral Pharmaceuticals, Inc.
Dosage Form Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route(s)
  • Dental - Administration to a tooth or teeth.
Active Ingredient(s)
  • SODIUM FLUORIDE 6 mg/mL
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 03-01-2015 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 12-31-2021 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.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

NDC Code Structure

  • 0126 - Colgate Oral Pharmaceuticals, Inc.
    • 0126-0072 - Prevident 5000 Booster Plus Fruitastic
      • 0126-0072-92 - 100 mL in 1 BOTTLE, PLASTIC

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.

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