Flector

Product NDC
52959-518
11-digit product format
529590518
Labeler code
52959
Product ID
52959-518_94fc9e99-c19d-4e8c-91be-b469ec44513d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Epolamine
Dosage form
PATCH
Route
TOPICAL
Labeler
H.J. Harkins Company, Inc.
Application
NDA021234
Marketing category
NDA
Marketing start
2008-01-14
Marketing end
0000-00-00
Substance
DICLOFENAC EPOLAMINE
Active strength
180 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-518-05Flector5 in 1 CARTONPATCH53
52959-518-30Flector30 in 1 CARTONPATCH303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-518-30EA - Each52959-51811dc4f14-dd53-459c-9beb-ae98c0ab757b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diclofenac EpolamineACTIVE INGREDIENTX5F8EKL9ZGFLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
DiclofenacACTIVE MOIETY144O8QL0L1FLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RAFLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS311FLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
Dihydroxyaluminum AminoacetateINACTIVE INGREDIENTDO250MG0W6FLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KFLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
GelatinINACTIVE INGREDIENT2G86QN327LFLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
KaolinINACTIVE INGREDIENT24H4NWX5COFLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TFLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HFLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
PovidoneINACTIVE INGREDIENTFZ989GH94EFLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3FLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHFLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
SorbitolINACTIVE INGREDIENT506T60A25RFLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
Tartaric AcidINACTIVE INGREDIENTW4888I119HFLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPFLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RFLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-518FLECTOR (DICLOFENAC EPOLAMINE) PATCH [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 2 package rows20120120_4bca1472-9a43-4510-a2de-5a2d80edbfbc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchPSN4bca1472-9a43-4510-a2de-5a2d80edbfbc3
855628Flector 1.3 % Twice-Daily Medicated PatchPSN4bca1472-9a43-4510-a2de-5a2d80edbfbc3
855628Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch [Flector]SBD4bca1472-9a43-4510-a2de-5a2d80edbfbc3
855626Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated PatchSCD4bca1472-9a43-4510-a2de-5a2d80edbfbc3
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchSY4bca1472-9a43-4510-a2de-5a2d80edbfbc3
855628Flector 1.3 % Twice-Daily Medicated PatchSY4bca1472-9a43-4510-a2de-5a2d80edbfbc3
855628Twice-Daily Flector 0.013 MG/MG Medicated PatchSY4bca1472-9a43-4510-a2de-5a2d80edbfbc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-518-05529590518055 in 1 CARTONHistorical
52959-518-305295905183030 in 1 CARTONHistorical