FDA.reportPublic FDA data

DICLOFENAC POTASSIUM

Product NDC
69315-506
11-digit product format
693150506
Labeler code
69315
Product ID
69315-506_9c24af27-0a21-4fb7-a8fb-55c92373b852
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICLOFENAC POTASSIUM
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Leading Pharma, LLC
Application
NDA022165
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-12-20
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
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
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
69315-506-09DICLOFENAC POTASSIUM1 in 1 PACKETPOWDER, FOR SOLUTION12
69315-506-09DICLOFENAC POTASSIUM9 in 1 CARTONPOWDER, FOR SOLUTION92

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-506-09EA - Each69315-506597279ad-7984-43d5-a7ec-cc5c4ea0466b12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-506DICLOFENAC POTASSIUM POWDER, FOR SOLUTION [LEADING PHARMA, LLC]2Current NDC, Legacy NDC, 2 package rows20240104_9dd418b2-4b0e-498c-b453-f580c69ddc6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859063diclofenac potassium 50 MG Powder for Oral SolutionPSN9dd418b2-4b0e-498c-b453-f580c69ddc6d2
859063diclofenac potassium 50 MG Powder for Oral SolutionSCD9dd418b2-4b0e-498c-b453-f580c69ddc6d2
859063Diclofenac K+ 50 MG Powder for Oral SolutionSY9dd418b2-4b0e-498c-b453-f580c69ddc6d2
859063Diclofenac Pot 50 MG Powder for Oral SolutionSY9dd418b2-4b0e-498c-b453-f580c69ddc6d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-506-09693150506099 PACKET in 1 CARTON (69315-506-09) / 1 POWDER, FOR SOLUTION in 1 PACKET9 packet2022-12-200000-00-00NoNoCurrent