FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
68788-8411
11-digit product format
687888411
Labeler code
68788
Product ID
68788-8411_8dfaa874-d6cf-4107-b57f-25dab02aa201
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075219
Marketing category
ANDA
Marketing start
2025-04-30
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8411-3Diclofenac Potassium30 in 1 BOTTLETABLET, FILM COATED301
68788-8411-6Diclofenac Potassium60 in 1 BOTTLETABLET, FILM COATED601
68788-8411-9Diclofenac Potassium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8411-3EA - Each68788-84118bf0d68d-f24d-4586-899d-801a4a5e94ed12025-07-08
68788-8411-6EA - Each68788-8411b38520f8-e295-4252-ae9f-9d696821e7d412025-07-08
68788-8411-9EA - Each68788-8411a192ded6-710c-4f35-bf87-03d65eae6b7012025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8411DICLOFENAC POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20250502_8dfaa874-d6cf-4107-b57f-25dab02aa201.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN8dfaa874-d6cf-4107-b57f-25dab02aa2011
855942diclofenac potassium 50 MG Oral TabletSCD8dfaa874-d6cf-4107-b57f-25dab02aa2011
855942Diclofenac K+ 50 MG Oral TabletSY8dfaa874-d6cf-4107-b57f-25dab02aa2011
855942Diclofenac Pot 50 MG Oral TabletSY8dfaa874-d6cf-4107-b57f-25dab02aa2011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8411-36878884110330 TABLET, FILM COATED in 1 BOTTLE (68788-8411-3) 2025-04-30NoNoHistorical
68788-8411-66878884110660 TABLET, FILM COATED in 1 BOTTLE (68788-8411-6) 2025-04-30NoNoHistorical
68788-8411-96878884110990 TABLET, FILM COATED in 1 BOTTLE (68788-8411-9) 2025-04-30NoNoHistorical