FDA.reportPublic FDA data

NEVANAC

Product NDC
0078-0778
11-digit product format
000780778
Labeler code
0078
Product ID
0078-0778_a2909252-c5f1-421f-9073-b7be90b45b51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nepafenac
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA021862
Marketing category
NDA
Marketing start
2005-09-06
Marketing end
0000-00-00
Substance
NEPAFENAC
Active strength
1 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
2023-12-31
Current FDA listing
Historical FDA.report record

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
0078-0778-032025-01-30C16284748780-12cef2736-6612-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use NEVANAC safely and effectively. See full prescribing information for NEVANAC. NEVANAC ® (nepafenac ophthalmic suspension) 0.1%, for topical ophthalmic use Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0778-03NEVANAC3 mL in 1 BOTTLESUSPENSION/ DROPS32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0778-03ML - Milliliter0078-077864e45c5f-0c08-430c-9d3d-78c1390b78f112023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0778NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION]2Legacy NDC, 1 package rows20230420_a2909252-c5f1-421f-9073-b7be90b45b51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
578044nepafenac 0.1 % Ophthalmic SuspensionPSNa2909252-c5f1-421f-9073-b7be90b45b512
603978Nevanac 0.1 % Ophthalmic SuspensionPSNa2909252-c5f1-421f-9073-b7be90b45b512
603978nepafenac 1 MG/ML Ophthalmic Suspension [Nevanac]SBDa2909252-c5f1-421f-9073-b7be90b45b512
578044nepafenac 1 MG/ML Ophthalmic SuspensionSCDa2909252-c5f1-421f-9073-b7be90b45b512
578044nepafenac 0.1 % Ophthalmic SuspensionSYa2909252-c5f1-421f-9073-b7be90b45b512
603978Nevanac 0.1 % Ophthalmic SuspensionSYa2909252-c5f1-421f-9073-b7be90b45b512
603978Nevanac 1 MG/ML Ophthalmic SuspensionSYa2909252-c5f1-421f-9073-b7be90b45b512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0778-03000780778033 mL in 1 BOTTLE (0078-0778-03) 3 ml2022-07-050000-00-00NoNoCurrent