FDA.reportPublic FDA data

diclofenac epolamine

Product NDC
80425-0364
11-digit product format
804250364
Labeler code
80425
Product ID
80425-0364_2a994ea2-2577-6513-e063-6394a90a7bc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac epolamine
Dosage form
SYSTEM
Route
TOPICAL
Labeler
Advanced Rx of Tennessee, LLC
Application
NDA021234
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-11-27
Substance
DICLOFENAC EPOLAMINE
Active strength
.013 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC EPOLAMINE.013 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX5F8EKL9ZG
Rxcui855626

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0364-1diclofenac epolamine5 in 1 POUCHSYSTEM52
80425-0364-1diclofenac epolamine6 in 1 CARTONSYSTEM62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0364-1EA - Each80425-0364fd0c6d4f-eea9-41f9-a8d3-7b83b2e3b19d12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0364DICLOFENAC EPOLAMINE SYSTEM [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 2 package rows20250101_08b8737f-b6d2-77da-e063-6294a90a1a3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchPSN08b8737f-b6d2-77da-e063-6294a90a1a3e2
855626Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated PatchSCD08b8737f-b6d2-77da-e063-6294a90a1a3e2
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchSY08b8737f-b6d2-77da-e063-6294a90a1a3e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0364-1804250364016 POUCH in 1 CARTON (80425-0364-1) / 5 SYSTEM in 1 POUCH6 pouch2023-11-27NoNoHistorical