Diclofenac Potassium

Product NDC
52959-659
11-digit product format
529590659
Labeler code
52959
Product ID
52959-659_a346079a-144b-47b0-ba63-cd3db2c05ce2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA075219
Marketing category
ANDA
Marketing start
2010-01-21
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
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-659-20Diclofenac Potassium20 in 1 BOTTLETABLET, FILM COATED201
52959-659-28Diclofenac Potassium28 in 1 BOTTLETABLET, FILM COATED281
52959-659-30Diclofenac Potassium30 in 1 BOTTLETABLET, FILM COATED301
52959-659-40Diclofenac Potassium40 in 1 BOTTLETABLET, FILM COATED401
52959-659-60Diclofenac Potassium60 in 1 BOTTLETABLET, FILM COATED601
52959-659-90Diclofenac Potassium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-659-20EA - Each52959-659c0bb7bba-1f86-4e8f-a17a-bfc408b7aa5412012-07-24
52959-659-28EA - Each52959-65914e98808-5962-40af-b35e-acb04733fd1012012-07-24
52959-659-30EA - Each52959-659fa1f1149-577b-488a-829e-4dd97636804e12012-07-24
52959-659-40EA - Each52959-6595a9d11be-4168-4f1c-81c0-818891067f9212012-07-24
52959-659-60EA - Each52959-659c8067616-eacb-4c8a-9736-b84ace5f4a5a12012-07-24
52959-659-90EA - Each52959-65976a9ee1c-a906-48cd-b137-97649df9b42b12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-659DICLOFENAC POTASSIUM TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 6 package rows20111212_0c3ac260-586d-4203-855b-f7518e89484e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN0c3ac260-586d-4203-855b-f7518e89484e1
855942diclofenac potassium 50 MG Oral TabletSCD0c3ac260-586d-4203-855b-f7518e89484e1
855942Diclofenac K+ 50 MG Oral TabletSY0c3ac260-586d-4203-855b-f7518e89484e1
855942Diclofenac Pot 50 MG Oral TabletSY0c3ac260-586d-4203-855b-f7518e89484e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-659-205295906592020 in 1 BOTTLEHistorical
52959-659-285295906592828 in 1 BOTTLEHistorical
52959-659-305295906593030 in 1 BOTTLEHistorical
52959-659-405295906594040 in 1 BOTTLEHistorical
52959-659-605295906596060 in 1 BOTTLEHistorical
52959-659-905295906599090 in 1 BOTTLEHistorical