80489-006 NDC - DRS. ANTIBIOTIC BACITRACIN (BACITRACIN)

Drug Information

  • Product NDC: 80489-006
  • Proprietary Name: Drs. Antibiotic Bacitracin
  • Non Proprietary Name: Bacitracin
  • Active Ingredient(s): 500 [USP'U]/g BACITRACIN ZINC
  • Administration Route(s): TOPICAL
  • Dosage Form(s): OINTMENT
  • Pharmacy Class(es): Decreased Cell Wall Synthesis & Repair [PE]

Labeler Information

Field Name Field Value
Labeler Name: OL PHARMA TECH, LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: M003
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:10/1/2021

Package Information

No. Package Code Package Description Billing Unit
180489-006-011 TUBE in 1 CARTON (80489-006-01) / 14 g in 1 TUBE
280489-006-021 TUBE in 1 CARTON (80489-006-02) / 28.3 g in 1 TUBE

NDC Record

Field Name Field Value Definition
PRODUCT NDC80489-006The 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 OTC DRUGThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAMEDrs. Antibiotic BacitracinThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBacitracinThis is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAMEOINTMENTProduct 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.
ROUTE NAMETOPICALThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
START MARKETING DATE10/1/2021Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct 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.
APPLICATION NUMBERM003This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEOL PHARMA TECH, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBACITRACIN ZINCAn 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 STRENGTH500 
ACTIVE INGRED UNIT[USP'U]/g 
PHARM CLASSESDecreased Cell Wall Synthesis & Repair [PE] 

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This page was last updated on: 12/6/2025

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