FDA.reportPublic FDA data

diclofenac epolamine

Product NDC
50436-1335
11-digit product format
504361335
Labeler code
50436
Product ID
50436-1335_f6f7d077-51eb-4e88-97cf-1bf2703c0d8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Epolamine
Dosage form
SYSTEM
Route
TOPICAL
Labeler
Unit Dose Services
Application
NDA021234
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-01-02
Marketing end
0000-00-00
Substance
DICLOFENAC EPOLAMINE
Active strength
0 g/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], 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
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-1335-12024-01-30C16284748780-11030e365-4ab2-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% safely and effectively. See full prescribing information for DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%. DICLOFENAC EPOLAMINE TOPICAL SYSTEM Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-1335-1diclofenac epolamine6 in 1 CARTONSYSTEM62
50436-1335-1diclofenac epolamine5 in 1 POUCHSYSTEM52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-1335-1EA - Each50436-1335e803d921-109e-4a30-8cd3-9041f42f753f12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-1335DICLOFENAC EPOLAMINE SYSTEM [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20220524_fb512554-c37e-4fd2-b06d-eadf7ab62442.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchPSNfb512554-c37e-4fd2-b06d-eadf7ab624422
855626Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated PatchSCDfb512554-c37e-4fd2-b06d-eadf7ab624422
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchSYfb512554-c37e-4fd2-b06d-eadf7ab624422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-1335-1504361335016 POUCH in 1 CARTON (50436-1335-1) > 5 SYSTEM in 1 POUCH6 pouch2022-03-010000-00-00NoNoCurrent