FDA.reportPublic FDA data

OZURDEX

Product NDC
0023-3348
11-digit product format
000233348
Labeler code
0023
Product ID
0023-3348_007c310d-2cfe-4c54-a27e-693e0d7fa78a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexamethasone
Dosage form
IMPLANT
Route
INTRAVITREAL
Labeler
Allergan, Inc.
Application
NDA022315
Marketing category
NDA
Marketing start
2009-09-01
Substance
DEXAMETHASONE
Active strength
.7 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OZURDEX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE.7 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui854177, 854181

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
0023-3348-07OZURDEX1 in 1 POUCHIMPLANT138
0023-3348-07OZURDEX1 in 1 CARTONIMPLANT138
0023-3348-08OZURDEX1 in 1 CARTONIMPLANT138
0023-3348-08OZURDEX1 in 1 POUCHIMPLANT138

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-3348-07EA - Each0023-334803187c19-2364-4417-954f-cf41e85eef4312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dexamethasoneACTIVE INGREDIENT7S5I7G3JQLOZURDEX (DEXAMETHASONE) IMPLANT [ALLERGAN, INC. ]12
dexamethasoneACTIVE MOIETY7S5I7G3JQLOZURDEX (DEXAMETHASONE) IMPLANT [ALLERGAN, INC. ]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-3348OZURDEX (DEXAMETHASONE) IMPLANT [ALLERGAN, INC.]29Current NDC, Legacy NDC, 4 package rows20250523_4b204f44-6e8a-4d17-803c-268f0b04679f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854177dexAMETHasone 0.7 MG Intravitreal Drug ImplantPSN4b204f44-6e8a-4d17-803c-268f0b04679f38
854181Ozurdex 0.7 MG Intravitreal Drug ImplantPSN4b204f44-6e8a-4d17-803c-268f0b04679f38
854181dexamethasone 0.7 MG Drug Implant [Ozurdex]SBD4b204f44-6e8a-4d17-803c-268f0b04679f38
854177dexamethasone 0.7 MG Drug ImplantSCD4b204f44-6e8a-4d17-803c-268f0b04679f38
854177dexamethasone 0.7 MG Intraocular Drug ImplantSY4b204f44-6e8a-4d17-803c-268f0b04679f38
854181Ozurdex 0.7 MG Intravitreal Drug ImplantSY4b204f44-6e8a-4d17-803c-268f0b04679f38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-3348-07000233348071 POUCH in 1 CARTON (0023-3348-07) / 1 IMPLANT in 1 POUCH1 pouch2009-09-010000-00-00NoNoCurrent
0023-3348-08000233348081 POUCH in 1 CARTON (0023-3348-08) / 1 IMPLANT in 1 POUCH1 pouch2009-09-010000-00-00YesNoCurrent