NDC 49348-154 Antibiotic Bacitracin Zinc
Bacitracin Zinc Ointment Topical

Product Information

What is NDC 49348-154?

The NDC code 49348-154 is assigned by the FDA to the product Antibiotic Bacitracin Zinc which is a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Antibiotic Bacitracin Zinc is bacitracin zinc. The product's dosage form is ointment and is administered via topical form. The product is distributed in a single package with assigned NDC code 49348-154-72 1 tube in 1 carton / 28.4 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code49348-154
Proprietary Name 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.
Antibiotic Bacitracin Zinc
Non-Proprietary Name 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.
Bacitracin Zinc
Product Type 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.
Human Otc Drug
Dosage FormOintment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Strategic Sourcing Services Llc
Labeler Code49348
FDA Application Number What is the FDA Application Number?
This 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.
part333B
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
05-11-2006
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Antibiotic Bacitracin Zinc?


Product Packages

NDC Code 49348-154-72

Package Description: 1 TUBE in 1 CARTON / 28.4 g in 1 TUBE

Price per Unit: $0.08460 per GM

Product Details

What are Antibiotic Bacitracin Zinc Active Ingredients?

An 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.
  • BACITRACIN ZINC 500 [iU]/g - A complex of cyclic peptide antibiotics produced by the Tracy-I strain of Bacillus subtilis. The commercial preparation is a mixture of at least nine bacitracins with bacitracin A as the major constituent. It is used topically to treat open infections such as infected eczema and infected dermal ulcers. (From Goodman and Gilman, The Pharmacological Basis of Therapeutics, 8th ed, p1140)

Antibiotic Bacitracin Zinc Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Antibiotic Bacitracin Zinc Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Bacitracin Topical

Bacitracin Topical is pronounced as (bass i tray' sin)

Why is bacitracin topical medication prescribed?
Bacitracin is used to help prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Bacitracin is in a class of medications called antibiotics...
[Read More]

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Antibiotic Bacitracin Zinc Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts

Distributed by McKesson
One Post Street
San Francisco, CA 94104


Active Ingredient (Each Gram Contains)



Bacitracin Zinc 500 units


Purpose



First aid antibiotic


Uses



first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings



For external use only


Do Not Use



  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Ask A Doctor Before Use



  • on deep or puncture wounds, animal bites, or serious burns

Stop Use And Ask A Doctor If



  • condition persists or gets worse
  • a rash or other allergic reaction develops

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • clean the affected area and dry thoroughly
  • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Other Information



  • To open: unscrew cap, pull tab to remove foil seal
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients



mineral oil, white petrolatum


Questions?



Call 1-866-923-4914


Principal Display Panel - 28.4 G Tube Carton



sunmark®

antibiotic ointment

Bacitracin Zinc Ointment USP
FIRST AID ANTIBIOTIC

NET WT 1 OZ (28.4 g)


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