83679-0000 NDC - ZINC OXIDE

Drug Information

Product NDC: 83679-0000

Proprietary Name:

Non Proprietary Name: Zinc Oxide

Active Ingredient(s):
  • 100 kg/100kg ZINC OXIDE


Administration Route(s):

Dosage Form(s): POWDER

Labeler Information

Labeler Name: Advance ZincTek Limited
Product Type: DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:9/21/2023

Package Information

No. Package Code Package Description Billing Unit
183679-0000-112.5 kg in 1 BOX (83679-0000-1)
283679-0000-2500 kg in 1 BAG (83679-0000-2)

NDC Record

Field Name Field Value Definition
PRODUCT NDC83679-0000The 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 NAMEDRUG FOR FURTHER PROCESSINGIndicates 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.
NON PROPRIETARY NAMEZinc OxideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPOWDERThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE9/21/2023This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEDRUG FOR FURTHER PROCESSINGProduct 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 NAMEAdvance ZincTek LimitedName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEZINC OXIDEAn 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 STRENGTH100 
ACTIVE INGRED UNITkg/100kg 

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This page was last updated on: 5/3/2024