DICLOFENAC POTASSIUM

Product NDC
60290-061
11-digit product format
602900061
Labeler code
60290
Product ID
60290-061_499a21c5-f2cf-9987-e063-6294a90a79fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac potassium
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Umedica Laboratories USA Inc.
Application
ANDA217010
Marketing category
ANDA
Marketing start
2026-02-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DICLOFENAC POTASSIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC POTASSIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL4D5UA6CB4
Rxcui859063

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60290-061-01DICLOFENAC POTASSIUM1 in 1 PACKETPOWDER, FOR SOLUTION11
60290-061-02DICLOFENAC POTASSIUM9 in 1 CARTONPOWDER, FOR SOLUTION91

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60290-061-01EA - Each60290-06104ad05a3-82af-4bf5-83a8-6b786421f4ef12026-05-22
60290-061-02EA - Each60290-0616ff17447-6b75-425a-85cb-65b21f91868212026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859063diclofenac potassium 50 MG Powder for Oral SolutionPSN33930285-dd97-415c-9e2a-491bd7b12af91
859063diclofenac potassium 50 MG Powder for Oral SolutionSCD33930285-dd97-415c-9e2a-491bd7b12af91
859063Diclofenac K+ 50 MG Powder for Oral SolutionSY33930285-dd97-415c-9e2a-491bd7b12af91
859063Diclofenac Pot 50 MG Powder for Oral SolutionSY33930285-dd97-415c-9e2a-491bd7b12af91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60290-061-01602900061011 POWDER, FOR SOLUTION in 1 PACKET (60290-061-01) 2026-02-15NoNoCurrent
60290-061-02602900061029 POWDER, FOR SOLUTION in 1 CARTON (60290-061-02) 2026-02-15NoNoCurrent