NDC 73614-454 Ixoba M

Moxifloxacin 0.5%, Ketorolac 0.5%, Prednisolone Acetate 1%

NDC Product Code 73614-454

NDC CODE: 73614-454

Proprietary Name: Ixoba M 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: Moxifloxacin 0.5%, Ketorolac 0.5%, Prednisolone Acetate 1% 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.

Product Characteristics

Color(s):
YELLOW (C48330 - YELLOW COLORED TRANSPARENT)

NDC Code Structure

  • 73614 - Brisk Pharmaceuticals, Inc.

NDC 73614-454-03

Package Description: 1 KIT in 1 CARTON * 1 BOTTLE in 1 CARTON > 5 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON > 3 mL in 1 BOTTLE * 5 mL in 1 BOTTLE

NDC Product Information

Ixoba M with NDC 73614-454 is a a human prescription drug product labeled by Brisk Pharmaceuticals, Inc.. The generic name of Ixoba M is moxifloxacin 0.5%, ketorolac 0.5%, prednisolone acetate 1%. The product's dosage form is kit and is administered via ophthalmic form.

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • WATER (UNII: 059QF0KO0R)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BISULFITE (UNII: TZX5469Z6I)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BORIC ACID (UNII: R57ZHV85D4)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • BORIC ACID (UNII: R57ZHV85D4)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)

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.

Product Labeler Information

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

Labeler Name: Brisk Pharmaceuticals, Inc.
Labeler Code: 73614
Marketing Category: UNAPPROVED DRUG OTHER - 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: 08-26-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Ixoba M Product Label Images

Ixoba M 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

Description

Rx OnlyNDC 73614-454-03For Use in Eyes OnlyIXOBA MEach Pack Contains:Moxifloxacin 0.5% Ophthalmic Solution - 3mlKetorolac 0.5% Ophthalmic Solution - 5mlPrednisolone Acetate 1% Ophthalmic Suspension - 5mlBrisk Pharmaceuticals

See Instructions on the bottom of the packageWhat is Ixoba M used for: Ixoba M is a convenient pack containing 3 ophthalmic medication bottles.
How Supplied: Ixoba M is supplied as a co-pack containing Moxifloxacin 0.5% Ophthalmic Suspension 3ml bottle, Ketorolac 0.5% Ophthalmic Suspension 5ml bottle, Prednisolone Acetate 1% Ophthalmic Suspen-sion 5ml bottle.
Storage: Store at 20C to 25C (68F-77F). Protect from light.
Please read the leaflet inside each bottle for ‘full prescribing information’ about that medication.Patient Counseling Information:Risk of Contamination: Do not touch the dropper tip to any surface to avoid contaminating the contents by common bacteria known to cause ocular infections.
Concomitant Use of Contact Lenses: Do not administer Moxifloxacin Ophthalmic Suspension, Ketorolac Ophthalmic Suspension or Prednisolone Acetate Ophthalmic Suspension while wearing contact lenses.
Concomitant Topical Ocular Therapy: If more than one topical ophthalmic medication is being used, the medications should be administered at least 5 minutes apart.
For questions on your ophthalmic medical condition or procedure, please call your Ophthalmologist office.
For questions on Ixoba M, please call your Ophthalmologist Office or Ixoba Assist at 866-694-9622

Keep out of the reach of children.TAMPER EVIDENT: Do not use the individual eye drops inside the pack if the seal on its carton is broken or missing.
Lot: See the lot number on each individual bottle inside the pack.
Exp: See the expiration date on each individual bottle inside the pack.
Packaged By: Unit Dose Solutions Inc., Morrisville, NC 27560Packaged for: Brisk Pharmaceuticals, Dallas, TX 75217

* Please review the disclaimer below.