FDA.reportPublic FDA data

Diclotral Pak

Product NDC
69329-510
11-digit product format
693290510
Labeler code
69329
Product ID
69329-510_2dd1e16d-c7dd-0eb6-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium, capsaicin
Dosage form
KIT
Route
TOPICAL
Labeler
Patchwerx Labs, Inc.
Application
ANDA202027
Marketing category
ANDA
Marketing start
2014-05-28
Marketing end
0000-00-00
Active strength
0
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
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
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
69329-510-012020-01-31C16284748780-19d75b9cf-f2b7-f424-e053-dadaa90a57ceDiclofenac Sodium Topical Solution, 1.5% (w/w) These highlights do not include all the information needed to use Diclofenac Sodium Topical Solution safely and effectively. See full prescribing information for Diclofenac Sodium Topical Solution. DICLOFENAC Sodium Topical Solution 1.5% w/w is for topical use only. Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0399-5Diclotral Pak150 mL in 1 BOTTLESOLUTION150 mL16.05 mg in 1mL4
60505-0399-5Diclotral Pak1 in 1 CARTONSOLUTION16.05 mg in 1mL4
69329-510-01Diclotral Pak1 in 1 CARTONKIT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69329-510-01ML - Milliliter69329-5108e782096-b7d0-425b-bef5-4c9acde5a9b912016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69329-510DICLOTRAL PAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PATCHWERX LABS, INC.]4Legacy NDC, 3 package rows20160312_2d8f4048-14cb-7484-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198555capsaicin 0.025 % Topical CreamPSN2d8f4048-14cb-7484-e054-00144ff88e884
857700diclofenac sodium 1.5 % Topical SolutionPSN2d8f4048-14cb-7484-e054-00144ff88e884
198555capsaicin 0.25 MG/ML Topical CreamSCD2d8f4048-14cb-7484-e054-00144ff88e884
857700diclofenac sodium 15 MG/ML Topical SolutionSCD2d8f4048-14cb-7484-e054-00144ff88e884
198555capsaicin 0.025 % Topical CreamSY2d8f4048-14cb-7484-e054-00144ff88e884
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY2d8f4048-14cb-7484-e054-00144ff88e884
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY2d8f4048-14cb-7484-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
60505-0399-560505039905150 mL in 1 BOTTLE150 mlHistorical
69329-510-01693290510011 in 1 CARTONHistorical