MAXIDEX

Product NDC
82667-600
11-digit product format
826670600
Labeler code
82667
Product ID
82667-600_34661206-e37a-6ce7-e063-6394a90aaf85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexamethasone
Dosage form
FOR SUSPENSION
Route
OPHTHALMIC
Labeler
Harrow Eye, LLC
Application
NDA013422
Marketing category
NDA
Marketing start
2025-04-07
Substance
DEXAMETHASONE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui205669, 309692

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
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
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82667-600-05MAXIDEX5 mL in 1 BOTTLE, PLASTICFOR SUSPENSION52
82667-600-05MAXIDEX1 in 1 CARTONFOR SUSPENSION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82667-600-05ML - Milliliter82667-600a867a4e9-0151-4eba-a8e3-a079ce26ca6712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82667-600MAXIDEX (DEXAMETHASONE) FOR SUSPENSION [HARROW EYE, LLC]2Current NDC, 2 package rows20250507_35e47fcd-e020-43e5-8322-41f8060d220d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309692dexAMETHasone 0.1 % Ophthalmic SuspensionPSN35e47fcd-e020-43e5-8322-41f8060d220d2
205669Maxidex 0.1 % Ophthalmic SuspensionPSN35e47fcd-e020-43e5-8322-41f8060d220d2
205669dexamethasone 1 MG/ML Ophthalmic Suspension [Maxidex]SBD35e47fcd-e020-43e5-8322-41f8060d220d2
309692dexamethasone 1 MG/ML Ophthalmic SuspensionSCD35e47fcd-e020-43e5-8322-41f8060d220d2
309692dexamethasone 0.1 % Ophthalmic SuspensionSY35e47fcd-e020-43e5-8322-41f8060d220d2
205669Maxidex 0.1 % Ophthalmic SuspensionSY35e47fcd-e020-43e5-8322-41f8060d220d2
205669Maxidex 1 MG/ML Ophthalmic SuspensionSY35e47fcd-e020-43e5-8322-41f8060d220d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82667-600-05826670600051 BOTTLE, PLASTIC in 1 CARTON (82667-600-05) / 5 mL in 1 BOTTLE, PLASTIC2025-04-07NoNoHistorical