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Animal NDC 51672-1354-1 Mupirocin

Animal Product Information

Field Name Field Value
Animal NDC Code 51672-1354-1
Proprietary Name Mupirocin 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 Mupirocin 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.
Labeler Name Taro Pharmaceuticals U.s.a., Inc.
Product Type Prescription Animal Drug
Usage Information
    Mupirocin ointment is indicated for the topical treatment of canine bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius.
Active Ingredient(s)
  • Mupirocin
Inactive Ingredient(s)
  • POLYETHYLENE GLYCOL 400 (B697894SGQ)
  • POLYETHYLENE GLYCOL 3350 (G2M7P15E5P)
  • POLYETHYLENE GLYCOL 400 (B697894SGQ)
  • POLYETHYLENE GLYCOL 3350 (G2M7P15E5P)
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION 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.
FDA Application Number ANADA200457 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.

Mupirocin Images

Mupirocin Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Caution



Federal law restricts this drug to use by or on the order of a licensed veterinarian.


Description



Each gram of mupirocin ointment contains 20 mg of mupirocin in a bland, water-washable ointment base consisting of polyethylene glycol 400 and polyethylene glycol 3350 (polyethylene glycol ointment). Mupirocin is a naturally-occurring, broad-spectrum antibiotic. The chemical name is 9-4-[5S-(2S,3S-epoxy-5S-hydroxy-4S-methylhexyl)-3R,4R-dihydroxytetrahydropyran-2S-yl]-3-methylbut-2(E)-enoyloxy-nonanoic acid. The chemical structure is:


Clinical Pharmacology



Mupirocin is a chemical entity produced by fermentation of the organism Pseudomonas fluorescens. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to this mode of action, mupirocin shows no cross resistance with chloramphenicol, erythromycin, gentamicin, lincomycin, neomycin, novobiocin, penicillin, streptomycin, and tetracycline. Mupirocin is an antimicrobial agent that inhibits the growth of gram-positive and gram-negative bacteria.

Bacteria susceptible to the action of mupirocin in vitro include the aerobic isolates of Staphylococcus aureus (including methicillin-resistant strains and β-lactamase-producing strains), Staphylococcus intermedius, Staphylococcus epidermidis, other coagulase positive or negative Staphylococci, α-hemolytic Streptococci, β group A Streptococci (including S. pyogenes), other β Streptococci (including S. agalactiae), group D Streptococci (including S. faecalis and S. faecium), group Viridans Streptococci, Streptococcus pneumoniae, Corynebacterium hofmanii, Bacillus subtilis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Enterobacter cloacae, Enterobacter aerogenes, Citrobacter freundii, Hemophilus influenzae (including β-lactamase-producing strains), Neisseria gonorrheae (including β-lactamase-producing strains), Neisseria meningitidis, Branhamella catarrhalis and Pasteurella multocida, and the anaerobic isolates of Peptostreptococcus anaerobius, Clostridium difficile, and Clostridium sporogenes.

Clinical significance of the in vitro data is unknown except for susceptible strains of Staphylcoccus aureus and Staphylococcus intermedius.


Indications For Use



Mupirocin ointment is indicated for the topical treatment of canine bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius.


Contraindications



This drug is contraindicated in animals with a history of sensitivity reactions to any of its components.


Warnings



Because of the potential hazard of nephrotoxicity due to the polyethylene glycol content of the base, care should be exercised when using this product in treating extensive deep lesions where absorption of large quantities of polyethylene glycol is possible.

Safety of use in pregnant or breeding animals has not been determined.

Mupirocin ointment is not for ophthalmic use.


Adverse Reactions



No adverse reactions have been reported with this product. If a skin reaction such as irritation should occur, treatment should be discontinued and appropriate therapy instituted.


Dosage And Administration



Prior to treatment, the lesion should be cleansed. Mupirocin ointment should be applied to the affected area twice a day. Apply a sufficient amount of ointment to completely cover the infected area. Maximum duration of treatment should not exceed 30 days.


How Supplied



Mupirocin ointment is supplied in 5 g, 15 g, 22 g, and 30 g tubes.


Storage And Handling



Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Keep Out of Reach of Children


Other



Mfd. by: Taro Pharmaceutical Industries Ltd.
Haifa Bay, Israel 2624761

Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Revised: November 2020

5210551-1120-0 37


Principal Display Panel - 22 G Tube Carton



NDC 51672-1354-0

Mupirocin
Ointment USP, 2%

For dermatologic use on dogs.
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Approved by FDA under ANADA # 200-457

Net Weight
22 g

Keep Out of Reach of Children.

TARO


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.