FDA.reportPublic FDA data

Maxitrol

Product NDC
82667-100
11-digit product format
826670100
Labeler code
82667
Product ID
82667-100_41ef9a7f-c1aa-de10-e063-6394a90adeec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and dexamethasone
Dosage form
SUSPENSION
Route
OPHTHALMIC
Labeler
Harrow Eye, LLC
Application
NDA050023
Marketing category
NDA
Marketing start
1964-11-15
Substance
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Maxitrol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE1 mg/mL
NEOMYCIN SULFATE3.5 mg/mL
POLYMYXIN B SULFATE10000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL, 057Y626693, 19371312D4
Rxcui208591, 309680

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82667-100-05Maxitrol5 mL in 1 BOTTLE, PLASTICSUSPENSION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82667-100-05ML - Milliliter82667-1007eee55a9-afce-4572-9f17-a266b4b1497012024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82667-100MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [HARROW EYE, LLC]4Current NDC, 1 package rows20241126_ecfb954f-5554-0ad2-e053-2995a90a7516.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208591Maxitrol 3.5 MG/mL / 10,000 UNT/mL / dexAMETHasone 0.1 % Ophthalmic SuspensionPSNecfb954f-5554-0ad2-e053-2995a90a75165
309680neomycin sulfate 3.5 MG/ML / polymyxin B sulfate 10,000 UNT/mL / dexAMETHasone 0.1 % Ophthalmic SuspensionPSNecfb954f-5554-0ad2-e053-2995a90a75165
208591dexamethasone 1 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic Suspension [Maxitrol]SBDecfb954f-5554-0ad2-e053-2995a90a75165
309680dexamethasone 1 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic SuspensionSCDecfb954f-5554-0ad2-e053-2995a90a75165
309680dexamethasone 0.1 % / neomycin 0.35 % / polymyxin B 10,000 UNT per ML Ophthalmic SuspensionSYecfb954f-5554-0ad2-e053-2995a90a75165
208591Maxitrol (neomycin 3.5 MG / polymyxin B 10,000 UNT / dexamethasone 1 MG) per 1 ML Ophthalmic SuspensionSYecfb954f-5554-0ad2-e053-2995a90a75165

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82667-100-05826670100055 mL in 1 BOTTLE, PLASTIC (82667-100-05) 5 ml2023-11-01NoNoHistorical