FDA.reportPublic FDA data

Diclofenac Epolamine

Product NDC
76420-673
11-digit product format
764200673
Labeler code
76420
Product ID
76420-673_1244caf6-4b25-dd22-e063-6294a90a81bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Epolamine
Dosage form
SYSTEM
Route
TOPICAL
Labeler
Asclemed USA, Inc.
Application
NDA021234
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-11-18
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-673-30Diclofenac Epolamine6 in 1 CARTONSYSTEM61
76420-673-30Diclofenac Epolamine5 in 1 POUCHSYSTEM51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-673DICLOFENAC EPOLAMINE SYSTEM [ASCLEMED USA, INC.]1Current NDC, 2 package rows20240228_45e191b6-c6c9-45f9-96d5-cf30f8aa910c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchPSN45e191b6-c6c9-45f9-96d5-cf30f8aa910c1
855626Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated PatchSCD45e191b6-c6c9-45f9-96d5-cf30f8aa910c1
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchSY45e191b6-c6c9-45f9-96d5-cf30f8aa910c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-673-30764200673306 POUCH in 1 CARTON (76420-673-30) / 5 SYSTEM in 1 POUCH6 pouch2024-02-26NoNoCurrent