Retisert

Product NDC
24208-416
11-digit product format
242080416
Labeler code
24208
Product ID
24208-416_4e5bdc52-d1c0-760f-e063-6294a90a0264
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone Acetonide
Dosage form
IMPLANT
Route
INTRAVITREAL
Labeler
Bausch & Lomb Incorporated
Application
NDA021737
Marketing category
NDA
Marketing start
2005-04-08
Substance
FLUOCINOLONE ACETONIDE
Active strength
.59 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
Retisert
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINOLONE ACETONIDE.59 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191323, 1191325

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-416-01Retisert1 in 1 POUCHIMPLANT116
24208-416-01Retisert1 in 1 CARTONIMPLANT116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-416-01EA - Each24208-41699d6828e-3559-4feb-bde8-8e36ea4c3f6512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOCINOLONE ACETONIDEACTIVE INGREDIENT0CD5FD6S2MRETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]7
FLUOCINOLONE ACETONIDEACTIVE MOIETY0CD5FD6S2MRETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]7
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990RETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-416RETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]15Current NDC, Legacy NDC, 2 package rows20250417_1ab0f849-2a0d-47ce-ad05-768094da8cc9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191323fluocinolone acetonide 0.59 MG Intravitreal Drug ImplantPSN1ab0f849-2a0d-47ce-ad05-768094da8cc916
1191325Retisert 0.59 MG Intravitreal Drug ImplantPSN1ab0f849-2a0d-47ce-ad05-768094da8cc916
1191325fluocinolone acetonide 0.59 MG Drug Implant [Retisert]SBD1ab0f849-2a0d-47ce-ad05-768094da8cc916
1191323fluocinolone acetonide 0.59 MG Drug ImplantSCD1ab0f849-2a0d-47ce-ad05-768094da8cc916
1191325Retisert 0.59 MG Drug ImplantSY1ab0f849-2a0d-47ce-ad05-768094da8cc916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-416-01242080416011 POUCH in 1 CARTON (24208-416-01) > 1 IMPLANT in 1 POUCH1 pouch2005-04-080000-00-00NoNoCurrent