69301-030 NDC - TOP QUALITY MFG APF (SODIUM FLUORIDE)

Drug Information

Product NDC: 69301-030

Proprietary Name: Top Quality Mfg APF

Non Proprietary Name: Sodium Fluoride

Active Ingredient(s):
  • 5.6 g/454g SODIUM FLUORIDE


Administration Route(s): DENTAL

Dosage Form(s): GEL

Labeler Information

Labeler Name: Top Quality Manufacturing, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:5/1/2014

Package Information

No. Package Code Package Description Billing Unit
169301-030-15454 g in 1 BOTTLE, PLASTIC (69301-030-15)

NDC Record

Field Name Field Value Definition
PRODUCT NDC69301-030The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMETop Quality Mfg APFThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMESodium FluorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEGELThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEDENTALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/1/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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.
LABELER NAMETop Quality Manufacturing, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESODIUM FLUORIDEAn 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.
ACTIVE NUMERATOR STRENGTH5.6 
ACTIVE INGRED UNITg/454g 

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This page was last updated on: 2/1/2023