FDA.reportPublic FDA data

Dexycu

Product NDC
71879-001
11-digit product format
718790001
Labeler code
71879
Product ID
71879-001_44fdffcc-1f20-6598-e063-6294a90aba36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexamethasone
Dosage form
INJECTION, SUSPENSION
Route
INTRAOCULAR
Labeler
EyePoint Pharmaceuticals US, Inc
Application
NDA208912
Marketing category
NDA
Marketing start
2018-05-22
Substance
DEXAMETHASONE
Active strength
517 ug/.005mL
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
Dexycu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE517 ug/.005mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL
Rxcui2045404, 2045409

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71879-001-012025-12-02C16284748780-12cef2736-9150-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DEXYCU ® safely and effectively. See full prescribing information for DEXYCU. DEXYCU (dexamethasone intraocular suspension) 9%, for intraocular administration Initial U.S. Approval: 1958
71879-001-012025-01-30C16284748780-12cef2736-9150-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DEXYCU ® safely and effectively. See full prescribing information for DEXYCU. DEXYCU (dexamethasone intraocular suspension) 9%, for intraocular administration Initial U.S. Approval: 1958

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71879-001-01Dexycu0.5 mL in 1 VIAL, GLASSINJECTION, SUSPENSION0.511
71879-001-01Dexycu1 in 1 CARTONINJECTION, SUSPENSION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71879-001-01ML - Milliliter71879-001dca775d9-0f8c-4527-bcd7-f463fee575a612018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71879-001DEXYCU (DEXAMETHASONE) INJECTION, SUSPENSION [EYEPOINT PHARMACEUTICALS US, INC]10Current NDC, Legacy NDC, 2 package rows20230429_583d70ed-bc42-465b-983d-c770db58406f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2045404dexAMETHasone 9 % in 0.005 ML Intraocular InjectionPSN583d70ed-bc42-465b-983d-c770db58406f11
2045409DEXYCU 9 % in 0.005 ML Intraocular InjectionPSN583d70ed-bc42-465b-983d-c770db58406f11
20454090.005 ML dexamethasone 103.4 MG/ML Injection [Dexycu]SBD583d70ed-bc42-465b-983d-c770db58406f11
20454040.005 ML dexamethasone 103.4 MG/ML InjectionSCD583d70ed-bc42-465b-983d-c770db58406f11
20454090.005 ML Dexycu 103.4 MG/ML InjectionSY583d70ed-bc42-465b-983d-c770db58406f11
2045404dexamethasone 517 MCG per 0.005 ML Intraocular InjectionSY583d70ed-bc42-465b-983d-c770db58406f11
2045404dexamethasone 9 % per 0.005 ML Intraocular InjectionSY583d70ed-bc42-465b-983d-c770db58406f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71879-001-01718790001011 VIAL, GLASS in 1 CARTON (71879-001-01) / .5 mL in 1 VIAL, GLASS2018-05-220000-00-00NoNoCurrent