NDC 72189-017 Bacitracin Zinc And Polymyxin B Sulfate

Bacitracin Zinc And Polymyxin B Sulfate

NDC Product Code 72189-017

NDC Code: 72189-017

Proprietary Name: Bacitracin Zinc And Polymyxin B Sulfate 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: Bacitracin Zinc And Polymyxin B Sulfate 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.

NDC Code Structure

  • 72189 - Direct_rx
    • 72189-017 - Bacitracin Zinc And Polymyxin B Sulfate

NDC 72189-017-35

Package Description: 3.5 g in 1 BOTTLE

NDC Product Information

Bacitracin Zinc And Polymyxin B Sulfate with NDC 72189-017 is a a human prescription drug product labeled by Direct_rx. The generic name of Bacitracin Zinc And Polymyxin B Sulfate is bacitracin zinc and polymyxin b sulfate. The product's dosage form is ointment and is administered via ophthalmic form.

Labeler Name: Direct_rx

Dosage Form: Ointment - 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.

Product Type: Human Prescription Drug 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.

Bacitracin Zinc And Polymyxin B Sulfate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BACITRACIN ZINC 500 [USP'U]/g
  • POLYMYXIN B SULFATE 10000 [USP'U]/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • MINERAL OIL (UNII: T5L8T28FGP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Decreased Cell Wall Synthesis & Repair - [PE] (Physiologic Effect)
  • Polymyxin-class Antibacterial - [EPC] (Established Pharmacologic Class)
  • Polymyxins - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Direct_rx
Labeler Code: 72189
FDA Application Number: ANDA064046 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New 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.

Start Marketing Date: 07-24-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Bacitracin Zinc And Polymyxin B Sulfate Product Label Images

Bacitracin Zinc And Polymyxin B Sulfate 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.

Product Labeling Index

Other

Rx only

Description

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP is a sterile antimicrobial ointment formulated for ophthalmic use.Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units/mg. The structural formula for bacitracin A is:[Bacitracin A (Strucural Formula)]Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units/mg, calculated on an anhydrous basis. The structural formulae are:[Polymyxin B Sulfate (Structural Formula)]Each gram contains: Actives: Bacitracin Zinc equal to 500 bacitracin units and Polymyxin B Sulfate equal to 10,000 polymyxin B units; Inactives: Mineral Oil and White Petrolatum.

Clinical Pharmacology

Polymyxin B sulfate attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and Haemophilus influenzae species.Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.

Indications & Usage

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.

Contraindications

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Warnings

Ophthalmic ointments may retard corneal healing.

Precautions

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Dosage & Administration

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.FOR OPHTHALMIC USE ONLY

How Supplied

HOW SUPPLIEDBacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP is available in tubes with an ophthalmic tip applicator in the following size:3.5 g tube DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.StorageStore between 15°-25°C (59°-77°F). KEEP TIGHTLY CLOSED.Keep out of reach of childrenBausch + Lomb, a division of

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA
© Bausch & Lomb IncorporatedRevised: November 20179130702 (Folded)

9130602 (Flat)

* Please review the disclaimer below.

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