NEVANAC

Product NDC
82667-500
11-digit product format
826670500
Labeler code
82667
Product ID
82667-500_42dbdcfd-3edd-46a3-e063-6394a90ac694
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nepafenac
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Harrow Eye, LLC
Application
NDA021862
Marketing category
NDA
Marketing start
2025-01-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NEVANAC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEPAFENAC1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J9L7J6V8C
Rxcui578044, 603978

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
e884a219-2715-9672-1489-3e3d6a8897e6Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82667-500-03NEVANAC1 in 1 CARTONSUSPENSION/ DROPS13
82667-500-03NEVANAC3 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82667-500-03ML - Milliliter82667-50049a258c7-232f-4fca-8a94-4f3d74869ebb12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82667-500NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [HARROW EYE, LLC]1Current NDC, 2 package rows20250101_11b9a0cf-2a70-17ef-e063-6394a90a5d9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
578044nepafenac 0.1 % Ophthalmic SuspensionPSN11b9a0cf-2a70-17ef-e063-6394a90a5d9e3
603978Nevanac 0.1 % Ophthalmic SuspensionPSN11b9a0cf-2a70-17ef-e063-6394a90a5d9e3
603978nepafenac 1 MG/ML Ophthalmic Suspension [Nevanac]SBD11b9a0cf-2a70-17ef-e063-6394a90a5d9e3
578044nepafenac 1 MG/ML Ophthalmic SuspensionSCD11b9a0cf-2a70-17ef-e063-6394a90a5d9e3
578044nepafenac 0.1 % Ophthalmic SuspensionSY11b9a0cf-2a70-17ef-e063-6394a90a5d9e3
603978Nevanac 0.1 % Ophthalmic SuspensionSY11b9a0cf-2a70-17ef-e063-6394a90a5d9e3
603978Nevanac 1 MG/ML Ophthalmic SuspensionSY11b9a0cf-2a70-17ef-e063-6394a90a5d9e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82667-500-03826670500031 BOTTLE, PLASTIC in 1 CARTON (82667-500-03) / 3 mL in 1 BOTTLE, PLASTIC2025-01-01NoNoHistorical