FDA.reportPublic FDA data

Flector

Product NDC
50436-1332
11-digit product format
504361332
Labeler code
50436
Product ID
50436-1332_0498faaf-5cd8-4aed-a750-444f16abf35f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Epolamine
Dosage form
PATCH
Route
TOPICAL
Labeler
Unit Dose Services
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
No
Listing certified through
2020-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-1332-12021-01-29C16284748780-1ba0f9c33-1868-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FLECTOR® PATCH safely and effectively. See full prescribing information for FLECTOR PATCH. FLECTOR® PATCH (diclofenac epolamine patch) 1.3%, for topical use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-1332-1Flector30 in 1 PATCHPATCH306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-1332-1EA - Each50436-1332323f205e-bd89-426a-a014-bb4546d1279112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diclofenac EpolamineACTIVE INGREDIENTX5F8EKL9ZGFLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
DiclofenacACTIVE MOIETY144O8QL0L1FLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RAFLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS311FLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
Dihydroxyaluminum AminoacetateINACTIVE INGREDIENTDO250MG0W6FLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KFLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
GelatinINACTIVE INGREDIENT2G86QN327LFLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
KaolinINACTIVE INGREDIENT24H4NWX5COFLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TFLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HFLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
PovidoneINACTIVE INGREDIENTFZ989GH94EFLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3FLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHFLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
SorbitolINACTIVE INGREDIENT506T60A25RFLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
Tartaric AcidINACTIVE INGREDIENTW4888I119HFLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPFLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2
WaterINACTIVE INGREDIENT059QF0KO0RFLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-1332FLECTOR (DICLOFENAC EPOLAMINE) PATCH [UNIT DOSE SERVICES]6Legacy NDC, 1 package rows20170702_f8b489ee-b48f-41b6-a759-c910e531576f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchPSNf8b489ee-b48f-41b6-a759-c910e531576f6
855628Flector 1.3 % Twice-Daily Medicated PatchPSNf8b489ee-b48f-41b6-a759-c910e531576f6
855628Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch [Flector]SBDf8b489ee-b48f-41b6-a759-c910e531576f6
855626Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated PatchSCDf8b489ee-b48f-41b6-a759-c910e531576f6
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchSYf8b489ee-b48f-41b6-a759-c910e531576f6
855628Flector 1.3 % Twice-Daily Medicated PatchSYf8b489ee-b48f-41b6-a759-c910e531576f6
855628Twice-Daily Flector 0.013 MG/MG Medicated PatchSYf8b489ee-b48f-41b6-a759-c910e531576f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-1332-15043613320130 in 1 PATCHHistorical