NEVANAC

Product NDC
0065-0002
11-digit product format
000650002
Labeler code
0065
Product ID
0065-0002_11a9d60d-4ea7-4c77-aee4-232a4df6591b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nepafenac
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0002-03ML - Milliliter0065-00028b2004cc-d398-4573-8c50-157c1045b25012012-07-24

DailyMed Socrata Ingredients#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
578044nepafenac 0.1 % Ophthalmic SuspensionPSN52fe0332-388a-451c-b759-97e7608838371
603978Nevanac 0.1 % Ophthalmic SuspensionPSN52fe0332-388a-451c-b759-97e7608838371
603978nepafenac 1 MG/ML Ophthalmic Suspension [Nevanac]SBD52fe0332-388a-451c-b759-97e7608838371
578044nepafenac 1 MG/ML Ophthalmic SuspensionSCD52fe0332-388a-451c-b759-97e7608838371
578044nepafenac 0.1 % Ophthalmic SuspensionSY52fe0332-388a-451c-b759-97e7608838371
603978Nevanac 0.1 % Ophthalmic SuspensionSY52fe0332-388a-451c-b759-97e7608838371
603978Nevanac 1 MG/ML Ophthalmic SuspensionSY52fe0332-388a-451c-b759-97e7608838371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0065-0002-03000650002033 mL in 1 BOTTLE, PLASTIC (0065-0002-03) 3 ml2005-09-060000-00-00NoNoCurrent