FDA.reportPublic FDA data

DICLOFENAC POTASSIUM

Product NDC
12634-827
11-digit product format
126340827
Labeler code
12634
Product ID
12634-827_bf8d9912-f32f-41d3-8173-a60c80fddc77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICLOFENAC POTASSIUM
Dosage form
TABLET
Route
ORAL
Labeler
APOTHECA, INC
Application
ANDA075229
Marketing category
ANDA
Marketing start
2007-08-20
Marketing end
0000-00-00
Substance
DICLOFENAC POTASSIUM
Active strength
50 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
2019-12-31
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
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
12634-827-002020-01-31C16284748780-19d75b9d0-b5d2-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM, TABLET USP
12634-827-502020-01-31C16284748780-19d75b9d0-b5d2-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM, TABLET USP
12634-827-542020-01-31C16284748780-19d75b9d0-b5d2-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM, TABLET USP
12634-827-592020-01-31C16284748780-19d75b9d0-b5d2-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM, TABLET USP
12634-827-602020-01-31C16284748780-19d75b9d0-b5d2-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM, TABLET USP
12634-827-612020-01-31C16284748780-19d75b9d0-b5d2-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM, TABLET USP
12634-827-712020-01-31C16284748780-19d75b9d0-b5d2-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM, TABLET USP
12634-827-782020-01-31C16284748780-19d75b9d0-b5d2-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM, TABLET USP
12634-827-802020-01-31C16284748780-19d75b9d0-b5d2-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM, TABLET USP
12634-827-812020-01-31C16284748780-19d75b9d0-b5d2-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM, TABLET USP
12634-827-842020-01-31C16284748780-19d75b9d0-b5d2-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM, TABLET USP
12634-827-852020-01-31C16284748780-19d75b9d0-b5d2-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM, TABLET USP
12634-827-912020-01-31C16284748780-19d75b9d0-b5d2-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM, TABLET USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-827-00DICLOFENAC POTASSIUM10 in 1 BOTTLETABLET101
12634-827-50DICLOFENAC POTASSIUM50 in 1 BOTTLETABLET501
12634-827-54DICLOFENAC POTASSIUM14 in 1 BLISTER PACKTABLET141
12634-827-59DICLOFENAC POTASSIUM30 in 1 BLISTER PACKTABLET301
12634-827-60DICLOFENAC POTASSIUM60 in 1 BOTTLETABLET601
12634-827-61DICLOFENAC POTASSIUM10 in 1 BLISTER PACKTABLET101
12634-827-71DICLOFENAC POTASSIUM30 in 1 BOTTLETABLET301
12634-827-78DICLOFENAC POTASSIUM28 in 1 BOTTLETABLET281
12634-827-80DICLOFENAC POTASSIUM20 in 1 BOTTLETABLET201
12634-827-81DICLOFENAC POTASSIUM21 in 1 BOTTLETABLET211
12634-827-84DICLOFENAC POTASSIUM14 in 1 BOTTLETABLET141
12634-827-85DICLOFENAC POTASSIUM15 in 1 BOTTLETABLET151
12634-827-91DICLOFENAC POTASSIUM1 in 1 BOTTLETABLET11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC POTASSIUMACTIVE INGREDIENTL4D5UA6CB4DICLOFENAC POTASSIUM TABLET [APOTHECA, INC]1
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC POTASSIUM TABLET [APOTHECA, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC POTASSIUM TABLET [APOTHECA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-827DICLOFENAC POTASSIUM TABLET [APOTHECA, INC]1Legacy NDC, 13 package rows20131119_645c97bc-5197-45a1-9802-2b4d43bd7496.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN645c97bc-5197-45a1-9802-2b4d43bd74961
855942diclofenac potassium 50 MG Oral TabletSCD645c97bc-5197-45a1-9802-2b4d43bd74961
855942Diclofenac K+ 50 MG Oral TabletSY645c97bc-5197-45a1-9802-2b4d43bd74961
855942Diclofenac Pot 50 MG Oral TabletSY645c97bc-5197-45a1-9802-2b4d43bd74961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-827-001263408270010 in 1 BOTTLEHistorical
12634-827-501263408275050 in 1 BOTTLEHistorical
12634-827-541263408275414 in 1 BLISTER PACKHistorical
12634-827-591263408275930 in 1 BLISTER PACKHistorical
12634-827-601263408276060 in 1 BOTTLEHistorical
12634-827-611263408276110 in 1 BLISTER PACKHistorical
12634-827-711263408277130 in 1 BOTTLEHistorical
12634-827-781263408277828 in 1 BOTTLEHistorical
12634-827-801263408278020 in 1 BOTTLEHistorical
12634-827-811263408278121 in 1 BOTTLEHistorical
12634-827-841263408278414 in 1 BOTTLEHistorical
12634-827-851263408278515 in 1 BOTTLEHistorical
12634-827-91126340827911 in 1 BOTTLEHistorical