FDA.reportPublic FDA data

DermasilkRx DicloPak

Product NDC
69329-330
11-digit product format
693290330
Labeler code
69329
Product ID
69329-330_1c948de4-dbc1-309a-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium delayed release tablets, ranitidine tablets, capsaicin cream
Dosage form
KIT
Labeler
Patchwerx Labs, Inc.
Application
ANDA074514
Marketing category
ANDA
Marketing start
2015-08-05
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
69329-330-002020-01-31C16284748780-19d75b9d0-d13b-f424-e053-dadaa90a57ce1c948de4-dbbf-309a-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0228-2551-06DermasilkRx DicloPak60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6075 mg1
69329-330-00DermasilkRx DicloPak1 in 1 PACKAGEKIT11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSICUM OLEORESINACTIVE INGREDIENTUW86K581WYDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
CAPSICUM OLEORESINACTIVE MOIETYUW86K581WYDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
DICLOFENACACTIVE MOIETY144O8QL0L1DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69329-330DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]1Legacy NDC, 2 package rows20150805_1c948de4-dbbf-309a-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN1c948de4-dbbf-309a-e054-00144ff8d46c1
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD1c948de4-dbbf-309a-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0228-2551-060022825510660 in 1 BOTTLE, PLASTICHistorical
69329-330-00693290330001 in 1 PACKAGEHistorical