FDA.reportPublic FDA data

Flector

Product NDC
21695-707
11-digit product format
216950707
Labeler code
21695
Product ID
21695-707_3c9f9507-8f72-4850-aa43-9ff5532f1396
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac epolamine
Dosage form
PATCH
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
NDA021234
Marketing category
NDA
Marketing start
2008-11-17
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-707-012019-09-24C16284748780-1934fe258-4b5a-48b1-e053-8cdaa90a720aFlector® Patch (diclofenac epolamine topical patch) 1.3%
21695-707-302019-09-24C16284748780-1934fe258-4b5a-48b1-e053-8cdaa90a720aFlector® Patch (diclofenac epolamine topical patch) 1.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-707-01Flector1 in 1 PACKAGEPATCH12
21695-707-30Flector30 in 1 BOXPATCH302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-707-01EA - Each21695-707133f80ff-d896-4690-a55b-aaa1e2495de312012-07-24
21695-707-30EA - Each21695-707e74728f7-2907-4fe1-8138-b8d7d8dfedc812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC EPOLAMINEACTIVE INGREDIENTX5F8EKL9ZGFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
DICLOFENACACTIVE MOIETY144O8QL0L1FLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
dihydroxyaluminum aminoacetateINACTIVE INGREDIENTDO250MG0W6FLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
gelatinINACTIVE INGREDIENT2G86QN327LFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
KAOLININACTIVE INGREDIENT24H4NWX5COFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
povidoneINACTIVE INGREDIENTFZ989GH94EFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3FLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
SORBITOLINACTIVE INGREDIENT506T60A25RFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
tartaric acidINACTIVE INGREDIENTW4888I119HFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2
waterINACTIVE INGREDIENT059QF0KO0RFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-707FLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]2Legacy NDC, 2 package rows20110224_e58641de-b6fd-484c-8902-b9262d7ce251.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchPSNe58641de-b6fd-484c-8902-b9262d7ce2512
855628Flector 1.3 % Twice-Daily Medicated PatchPSNe58641de-b6fd-484c-8902-b9262d7ce2512
855628Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch [Flector]SBDe58641de-b6fd-484c-8902-b9262d7ce2512
855626Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated PatchSCDe58641de-b6fd-484c-8902-b9262d7ce2512
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchSYe58641de-b6fd-484c-8902-b9262d7ce2512
855628Flector 1.3 % Twice-Daily Medicated PatchSYe58641de-b6fd-484c-8902-b9262d7ce2512
855628Twice-Daily Flector 0.013 MG/MG Medicated PatchSYe58641de-b6fd-484c-8902-b9262d7ce2512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-707-01216950707011 in 1 PACKAGEHistorical
21695-707-302169507073030 in 1 BOXHistorical