NDC 69301-030-15 Top Quality Mfg Apf

Sodium Fluoride

  1. Labeler Index
  2. Top Quality Manufacturing, Inc.
  3. 69301-030
  4. NDC Code: 69301-030-15 Top Quality Mfg Apf

NDC Package Code 69301-030-15

The NDC Code 69301-030-15 is assigned to a package of 454 g in 1 bottle, plastic of Top Quality Mfg Apf, a human prescription drug labeled by Top Quality Manufacturing, Inc.. The product's dosage form is gel and is administered via dental form.

Field Name Field Value
NDC Code 69301-030-15
Package Description 454 g in 1 BOTTLE, PLASTIC
Proprietary Name Top Quality Mfg Apf 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 69301003015 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.
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 Top Quality Manufacturing, Inc.
Dosage Form Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s)
  • Dental - Administration to a tooth or teeth.
Active Ingredient(s)
  • SODIUM FLUORIDE 5.6 g/454g
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 05-01-2014 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. Values = ‘Y’ or ‘N’.

NDC Code Structure

  • 69301 - Top Quality Manufacturing, Inc.
    • 69301-030 - Top Quality Mfg Apf
      • 69301-030-15 - 454 g 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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