FDA.reportPublic FDA data

MAXITROL

Product NDC
0078-0771
11-digit product format
000780771
Labeler code
0078
Product ID
0078-0771_6328676b-98d9-4548-bc41-117e0e21eba6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and dexamethasone
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA050065
Marketing category
NDA
Marketing start
1972-01-17
Marketing end
2027-02-28
Substance
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
1; 3.5; 10000 mg/g; mg/g; [USP'U]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MAXITROL

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL, 057Y626693, 19371312D4
Rxcui208601, 309679

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
0078-0771-01MAXITROL3.5 g in 1 TUBEOINTMENT3.56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0771MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) OINTMENT [NOVARTIS PHARMACEUTICALS CORPORATION]4Current NDC, Legacy NDC, 1 package rows20230628_22c6d2db-85af-4a3b-a014-80d901a86717.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN22c6d2db-85af-4a3b-a014-80d901a867176
208601Maxitrol 1 MG / 3.5 MG / 10,000 UNT per GM Ophthalmic OintmentPSN22c6d2db-85af-4a3b-a014-80d901a867176
208601dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment [Maxitrol]SBD22c6d2db-85af-4a3b-a014-80d901a867176
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD22c6d2db-85af-4a3b-a014-80d901a867176
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSY22c6d2db-85af-4a3b-a014-80d901a867176
208601Maxitrol (neomycin 3.5 MG / polymyxin b 10,000 UNT / dexamethasone 1 MG) per GM Ophthalmic OintmentSY22c6d2db-85af-4a3b-a014-80d901a867176

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0771-01000780771013.5 g in 1 TUBE (0078-0771-01) 3.5 g2020-08-252027-02-28NoNoCurrent