FDA.reportPublic FDA data

ILEVRO

Product NDC
0078-0743
11-digit product format
000780743
Labeler code
0078
Product ID
0078-0743_4e6e6db9-e1cf-83cb-e063-6294a90a2420
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nepafenac
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA203491
Marketing category
NDA
Marketing start
2012-12-20
Substance
NEPAFENAC
Active strength
3 mg/mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEPAFENAC3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J9L7J6V8C
Rxcui1362132, 1365866

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e884a219-2715-9672-1489-3e3d6a8897e6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0078-0743-032025-01-30C16284748780-12cef2736-81fe-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ILEVRO ® safely and effectively. See full prescribing information for ILEVRO. ILEVRO ® (nepafenac ophthalmic suspension), topical ophthalmic Initial U.S. Approval: 2005
0078-0743-962025-01-30C16284748780-12cef2736-81fe-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ILEVRO ® safely and effectively. See full prescribing information for ILEVRO. ILEVRO ® (nepafenac ophthalmic suspension), topical ophthalmic Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0743-03ILEVRO3 mL in 1 BOTTLESUSPENSION/ DROPS35
0078-0743-03ILEVRO1 in 1 CARTONSUSPENSION/ DROPS15
0078-0743-96ILEVRO1 in 1 CARTONSUSPENSION/ DROPS15
0078-0743-96ILEVRO0.8 mL in 1 BOTTLESUSPENSION/ DROPS0.85

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0743-03ML - Milliliter0078-0743af0eb0ff-6cf8-4c1c-b651-88ec0600668512021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0743ILEVRO (NEPAFENAC) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION]4Current NDC, Legacy NDC, 4 package rows20230421_f089b583-0310-4ca8-8d41-52b06b08d1ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1365866ILEVRO 0.3 % Ophthalmic SuspensionPSNf089b583-0310-4ca8-8d41-52b06b08d1ed5
1362132nepafenac 0.3 % Ophthalmic SuspensionPSNf089b583-0310-4ca8-8d41-52b06b08d1ed5
1365866nepafenac 3 MG/ML Ophthalmic Suspension [Ilevro]SBDf089b583-0310-4ca8-8d41-52b06b08d1ed5
1362132nepafenac 3 MG/ML Ophthalmic SuspensionSCDf089b583-0310-4ca8-8d41-52b06b08d1ed5
1365866Ilevro 0.3 % Ophthalmic SuspensionSYf089b583-0310-4ca8-8d41-52b06b08d1ed5
1365866Ilevro 3 MG/ML Ophthalmic SuspensionSYf089b583-0310-4ca8-8d41-52b06b08d1ed5
1362132nepafenac 0.3 % Ophthalmic SuspensionSYf089b583-0310-4ca8-8d41-52b06b08d1ed5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0743-03000780743031 BOTTLE in 1 CARTON (0078-0743-03) > 3 mL in 1 BOTTLE1 bottle2021-01-150000-00-00NoNoCurrent
0078-0743-96000780743961 BOTTLE in 1 CARTON (0078-0743-96) > .8 mL in 1 BOTTLE1 bottle2021-01-150000-00-00YesNoCurrent