Diclofenac Potassium

Product NDC
68151-0561
11-digit product format
681510561
Labeler code
68151
Product ID
68151-0561_8de83a42-e3cc-47c4-99ef-74e1b0cc4582
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA075219
Marketing category
ANDA
Marketing start
1998-08-11
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
2018-12-31
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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
68151-0561-02020-01-31C16284748780-19d75b9d0-0796-f424-e053-dadaa90a57ceDICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-0561-0Diclofenac Potassium1 in 1 PACKAGETABLET, FILM COATED14

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-0561DICLOFENAC POTASSIUM TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20170724_7dfb36a4-3064-4639-9167-23d1c7d1bee9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN7dfb36a4-3064-4639-9167-23d1c7d1bee94
855942diclofenac potassium 50 MG Oral TabletSCD7dfb36a4-3064-4639-9167-23d1c7d1bee94
855942Diclofenac K+ 50 MG Oral TabletSY7dfb36a4-3064-4639-9167-23d1c7d1bee94
855942Diclofenac Pot 50 MG Oral TabletSY7dfb36a4-3064-4639-9167-23d1c7d1bee94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-0561-0681510561001 in 1 PACKAGEHistorical