FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
50090-5893
11-digit product format
500905893
Labeler code
50090
Product ID
50090-5893_b6546725-2742-4aef-a3cf-0c53aeaea638
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075229
Marketing category
ANDA
Marketing start
2020-12-19
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
50090-5893-0Diclofenac Potassium30 in 1 BOTTLETABLET, COATED303
50090-5893-1Diclofenac Potassium21 in 1 BOTTLETABLET, COATED213
50090-5893-3Diclofenac Potassium45 in 1 BOTTLETABLET, COATED453
50090-5893-4Diclofenac Potassium90 in 1 BOTTLETABLET, COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5893-0EA - Each50090-58936b315439-1ff0-4db2-b637-1caa5350248412022-06-06
50090-5893-1EA - Each50090-58935dde82cc-00d6-451f-91a8-7fcffad8167c12022-06-06
50090-5893-3EA - Each50090-589374caf017-4b2d-4473-a3d5-6db694f7b96012022-06-06
50090-5893-4EA - Each50090-5893f28abe34-1fa0-44bb-8550-9fbfe5cbd11612022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5893DICLOFENAC POTASSIUM TABLET, COATED [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 4 package rows20231125_112e7c94-23c8-451e-ae71-eb89a6eb2cb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN112e7c94-23c8-451e-ae71-eb89a6eb2cb23
855942diclofenac potassium 50 MG Oral TabletSCD112e7c94-23c8-451e-ae71-eb89a6eb2cb23
855942Diclofenac K+ 50 MG Oral TabletSY112e7c94-23c8-451e-ae71-eb89a6eb2cb23
855942Diclofenac Pot 50 MG Oral TabletSY112e7c94-23c8-451e-ae71-eb89a6eb2cb23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5893-05009058930030 TABLET, COATED in 1 BOTTLE (50090-5893-0) 2022-01-120000-00-00NoNoCurrent
50090-5893-15009058930121 TABLET, COATED in 1 BOTTLE (50090-5893-1) 2022-01-160000-00-00NoNoCurrent
50090-5893-35009058930345 TABLET, COATED in 1 BOTTLE (50090-5893-3) 2022-01-160000-00-00NoNoCurrent
50090-5893-45009058930490 TABLET, COATED in 1 BOTTLE (50090-5893-4) 2022-01-160000-00-00NoNoCurrent