FLECTOR

Product NDC
61919-566
11-digit product format
619190566
Labeler code
61919
Product ID
61919-566_4418b335-8108-1395-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLECTOR
Dosage form
PATCH
Route
TOPICAL
Labeler
DIRECT RX
Application
NDA021234
Marketing category
NDA
Marketing start
2014-01-01
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-566-30FLECTOR30 in 1 CARTONPATCH304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-566-30EA - Each61919-566663e7788-d204-4c93-b637-21087459908e12016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diclofenac EpolamineACTIVE INGREDIENTX5F8EKL9ZGFLECTOR PATCH [DIRECT RX]1
DICLOFENACACTIVE MOIETY144O8QL0L1FLECTOR PATCH [DIRECT RX]1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RAFLECTOR PATCH [DIRECT RX]1
Dihydroxyaluminum AminoacetateINACTIVE INGREDIENTDO250MG0W6FLECTOR PATCH [DIRECT RX]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KFLECTOR PATCH [DIRECT RX]1
GelatinINACTIVE INGREDIENT2G86QN327LFLECTOR PATCH [DIRECT RX]1
KaolinINACTIVE INGREDIENT24H4NWX5COFLECTOR PATCH [DIRECT RX]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TFLECTOR PATCH [DIRECT RX]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HFLECTOR PATCH [DIRECT RX]1
PovidonesINACTIVE INGREDIENTFZ989GH94EFLECTOR PATCH [DIRECT RX]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3FLECTOR PATCH [DIRECT RX]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHFLECTOR PATCH [DIRECT RX]1
SorbitolINACTIVE INGREDIENT506T60A25RFLECTOR PATCH [DIRECT RX]1
Tartaric AcidINACTIVE INGREDIENTW4888I119HFLECTOR PATCH [DIRECT RX]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPFLECTOR PATCH [DIRECT RX]1
WaterINACTIVE INGREDIENT059QF0KO0RFLECTOR PATCH [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-566FLECTOR PATCH [DIRECT RX]4Legacy NDC, 1 package rows20161220_0f11e37c-1aa4-455a-98b8-6aae72294a25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchPSN0f11e37c-1aa4-455a-98b8-6aae72294a254
855626Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated PatchSCD0f11e37c-1aa4-455a-98b8-6aae72294a254
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchSY0f11e37c-1aa4-455a-98b8-6aae72294a254

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-566-306191905663030 in 1 CARTONHistorical