DICLOFENAC POTASSIUM

Product NDC
61919-072
11-digit product format
619190072
Labeler code
61919
Product ID
61919-072_94e0cb71-8725-d8a5-e053-2995a90a6792
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICLOFENAC POTASSIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA075219
Marketing category
ANDA
Marketing start
2014-01-01
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
2020-12-31
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
61919-072-302023-01-30C16284748780-1f386c649-aaf8-0266-e053-dadaa90a7c1aDICLOFENAC POTASSIUM
61919-072-602023-01-30C16284748780-1f386c649-aaf8-0266-e053-dadaa90a7c1aDICLOFENAC POTASSIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-072-30DICLOFENAC POTASSIUM30 in 1 BOTTLETABLET, FILM COATED306
61919-072-60DICLOFENAC POTASSIUM60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-072-30EA - Each61919-072703db6e9-eeaf-416d-a01d-6b2bc78b0d7c12014-05-02
61919-072-60EA - Each61919-07212e20a66-0723-4c65-89cf-ad453b3c990012019-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC POTASSIUMACTIVE INGREDIENTL4D5UA6CB4DICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95DICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EDICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666DICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-072DICLOFENAC POTASSIUM TABLET, FILM COATED [DIRECT RX]6Legacy NDC, 2 package rows20191015_85da6c5c-a1ec-4ea0-9fbb-2012f63931be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN85da6c5c-a1ec-4ea0-9fbb-2012f63931be6
855942diclofenac potassium 50 MG Oral TabletSCD85da6c5c-a1ec-4ea0-9fbb-2012f63931be6
855942Diclofenac K+ 50 MG Oral TabletSY85da6c5c-a1ec-4ea0-9fbb-2012f63931be6
855942Diclofenac Pot 50 MG Oral TabletSY85da6c5c-a1ec-4ea0-9fbb-2012f63931be6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-072-306191900723030 TABLET, FILM COATED in 1 BOTTLE (61919-072-30) 2014-01-010000-00-00NoNoCurrent
61919-072-606191900726060 TABLET, FILM COATED in 1 BOTTLE (61919-072-60) 2014-01-010000-00-00NoNoCurrent