FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
80425-0456
11-digit product format
804250456
Labeler code
80425
Product ID
80425-0456_295d1f3d-6cc2-4c95-e063-6394a90aeea6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA215787
Marketing category
ANDA
Marketing start
2024-12-15
Substance
DICLOFENAC POTASSIUM
Active strength
50 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC POTASSIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL4D5UA6CB4
Rxcui855942

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0456-1Diclofenac Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
80425-0456-2Diclofenac Potassium60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
80425-0456-3Diclofenac Potassium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0456-1EA - Each80425-0456f23cc9b6-310e-492a-b6f8-17059b89e39112025-02-10
80425-0456-2EA - Each80425-0456e1651a18-01c0-4f76-a7b8-d90cf23875d612025-02-10
80425-0456-3EA - Each80425-0456a2e433ab-1879-484e-98e9-7260c083c44b12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0456DICLOFENAC POTASSIUM TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20241218_295d167c-eb56-8e14-e063-6394a90ad325.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN295d167c-eb56-8e14-e063-6394a90ad3251
855942diclofenac potassium 50 MG Oral TabletSCD295d167c-eb56-8e14-e063-6394a90ad3251
855942Diclofenac K+ 50 MG Oral TabletSY295d167c-eb56-8e14-e063-6394a90ad3251
855942Diclofenac Pot 50 MG Oral TabletSY295d167c-eb56-8e14-e063-6394a90ad3251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0456-18042504560130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0456-1) 2024-12-15NoNoCurrent
80425-0456-28042504560260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0456-2) 2024-12-15NoNoCurrent
80425-0456-38042504560390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0456-3) 2024-12-15NoNoCurrent