diclofenac epolamine

Product NDC
50436-3727
11-digit product format
504363727
Labeler code
50436
Product ID
50436-3727_88a7932d-07a2-4c42-a987-7583d0da5179
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
2020-05-01
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3727-1diclofenac epolamine6 in 1 CARTONSYSTEM62
50436-3727-1diclofenac epolamine5 in 1 POUCHSYSTEM52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3727-1EA - Each50436-372747cb48eb-8927-4f0d-9f7c-e6ec50d1c8d212022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3727DICLOFENAC EPOLAMINE SYSTEM [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20220727_18593350-32df-4562-8bfe-e38de53e2b93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchPSN18593350-32df-4562-8bfe-e38de53e2b932
855626Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated PatchSCD18593350-32df-4562-8bfe-e38de53e2b932
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchSY18593350-32df-4562-8bfe-e38de53e2b932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-3727-1504363727016 POUCH in 1 CARTON (50436-3727-1) > 5 SYSTEM in 1 POUCH6 pouch2022-07-010000-00-00NoNoCurrent