IXOBA M

Manufacturer
Brisk Pharmaceuticals, Inc. | Unit Dose Solutions, Inc
Effective date
2021-11-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:38:15

Label Images#

IXOBA M insert front
IXOBA M insert front
IXOBA M insert back
IXOBA M insert back
IXOBA M box
IXOBA M box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN2
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN2
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN2
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD2
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD2
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD2
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY2
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY2
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOROLAC Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
MOXIFLOXACIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230421
PREDNISOLONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
84b851da-be59-d750-14d1-e4d93cc3b4daProduct name920250630
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659Product name220250218
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
2194a6ab-15bb-de49-cced-f09e642b1b64Product name820240313
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5Product name220240102
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611
18d57d04-4a34-a130-5dd5-b7fc47f3b567Product name120140508
379bc253-901a-e6e1-92b7-0fc574249e07Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954Product name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
9f10552a-9a7b-8e6c-3223-dc44310af6cfProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73614-454-032023-01-30C16284748780-1f386c649-bdae-0266-e053-dadaa90a7c1aIXOBA M

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73614-454-03IXOBA M1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73614-454IXOBA M (MOXIFLOXACIN 0.5%, KETOROLAC 0.5%, PREDNISOLONE ACETATE 1%) KIT [BRISK PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20211104_ca7a8de8-9185-e89f-e053-2995a90a5e04.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-126-05ML - Milliliter61314-126f4fb4671-d063-4c4d-aec0-6375e56e8f4412012-07-24
61314-126-10ML - Milliliter61314-126432b55f9-20ea-4307-873d-9d0c70b80b5a12012-07-24
60758-119-05ML - Milliliter60758-1190583cff3-db8a-4969-82eb-c9947fd1ba4112012-07-24
60758-119-10ML - Milliliter60758-1193e1bf846-dac5-439d-b5a3-be6d4a18c71712012-07-24
60758-119-15ML - Milliliter60758-1195377df34-3004-4e14-8fcd-1b41cca8692012012-07-24
68180-422-01ML - Milliliter68180-422e6bd441f-79e7-4e7a-9f6c-87d36199ac0012017-08-11

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73614-45473614-454-03
61314-126
60758-119
68180-422

Ingredients#

Complete SPL Sections#

DESCRIPTION SECTION

DESCRIPTION SECTION

Rx Only NDC 73614-454-03 For Use in Eyes Only IXOBA M Each Pack Contains: Moxifloxacin 0.5% Ophthalmic Solution - 3ml Ketorolac 0.5% Ophthalmic Solution - 5ml Prednisolone Acetate 1% Ophthalmic Suspension - 5ml Brisk Pharmaceuticals

DESCRIPTION SECTION

DESCRIPTION SECTION

See Instructions on the bottom of the package What 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 Ixoba M , please call your Ophthalmologist Office or Ixoba Assist at 469-342-1471.

DESCRIPTION SECTION

DESCRIPTION SECTION

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 27560 Packaged for: Brisk Pharmaceuticals, Dallas, TX 75217

Source Document#

Source XML