FDA.reportPublic FDA data

Diclofenac Epolamine

Product NDC
80425-0403
11-digit product format
804250403
Labeler code
80425
Product ID
80425-0403_1b563e42-3b07-5320-e063-6294a90a30e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Epolamine
Dosage form
SYSTEM
Route
TOPICAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
NDA021234
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-06-19
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
80425-0403-1Diclofenac Epolamine6 in 1 CARTONSYSTEM61
80425-0403-1Diclofenac Epolamine5 in 1 POUCHSYSTEM51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0403-1EA - Each80425-040309e1982f-0de8-4234-91ff-1ddd54546f6f12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0403DICLOFENAC EPOLAMINE SYSTEM [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 2 package rows20240622_1b563e42-3b06-5320-e063-6294a90a30e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchPSN1b563e42-3b06-5320-e063-6294a90a30e51
855626Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated PatchSCD1b563e42-3b06-5320-e063-6294a90a30e51
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchSY1b563e42-3b06-5320-e063-6294a90a30e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0403-1804250403016 POUCH in 1 CARTON (80425-0403-1) / 5 SYSTEM in 1 POUCH6 pouch2024-06-19NoNoCurrent