LICART

Product NDC
71858-0305
11-digit product format
718580305
Labeler code
71858
Product ID
71858-0305_4e7d176c-1593-6214-e063-6394a90a4042
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac epolamine
Dosage form
SYSTEM
Route
TOPICAL
Labeler
IBSA Pharma Inc.
Application
NDA206976
Marketing category
NDA
Marketing start
2020-09-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LICART
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX5F8EKL9ZG
Rxcui2372911, 2385117

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac74f96-3910-44b9-8551-036880fbb1fbProduct name120260108
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
2c999b01-2a13-4eff-8eb4-00b87316ef79Product name120231116
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
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71858-0305-1LICART2 in 1 POUCHSYSTEM215
71858-0305-2LICART1 in 1 CARTONSYSTEM115
71858-0305-4LICART5 in 1 POUCHSYSTEM515
71858-0305-5LICART3 in 1 CARTONSYSTEM315

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71858-0305-2EA - Each71858-030504a16a93-66fb-454b-a738-4cbb3773b48a12020-07-13
71858-0305-4EA - Each71858-0305a13300d9-a67f-4ce6-b09e-a6272dc160de12020-07-13
71858-0305-5EA - Each71858-0305004b98cd-9034-45b7-a4d7-36783d01390a12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71858-0305LICART (DICLOFENAC EPOLAMINE) SYSTEM [IBSA PHARMA INC.]13Current NDC, Legacy NDC, 4 package rows20241201_851c8b39-6056-4bbc-812e-b9b13977c1ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2385117diclofenac epolamine 1.3 % Once-Daily Medicated PatchPSN851c8b39-6056-4bbc-812e-b9b13977c1ac15
2372911Licart 1.3 % Once-Daily Medicated PatchPSN851c8b39-6056-4bbc-812e-b9b13977c1ac15
2372911Once-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch [Licart]SBD851c8b39-6056-4bbc-812e-b9b13977c1ac15
2385117Once-Daily diclofenac epolamine 0.013 MG/MG Medicated PatchSCD851c8b39-6056-4bbc-812e-b9b13977c1ac15
2385117diclofenac epolamine 1.3 % Once-Daily Medicated PatchSY851c8b39-6056-4bbc-812e-b9b13977c1ac15
2372911Licart 1.3 % Once-Daily Medicated PatchSY851c8b39-6056-4bbc-812e-b9b13977c1ac15
2372911Once-Daily Licart 0.013 MG/MG Medicated PatchSY851c8b39-6056-4bbc-812e-b9b13977c1ac15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71858-0305-1718580305012 in 1 POUCHHistorical
71858-0305-2718580305021 POUCH in 1 CARTON (71858-0305-2) / 2 SYSTEM in 1 POUCH (71858-0305-1) 1 pouch2020-09-010000-00-00YesNoCurrent
71858-0305-4718580305045 in 1 POUCHHistorical
71858-0305-5718580305053 POUCH in 1 CARTON (71858-0305-5) / 5 SYSTEM in 1 POUCH (71858-0305-4) 3 pouch2020-09-010000-00-00NoNoCurrent