FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
69315-275
11-digit product format
693150275
Labeler code
69315
Product ID
69315-275_9f4d938d-3f9c-41b0-bb9b-82fd4487cf66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Potassium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Leading Pharma, LLC
Application
NDA022202
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-03-24
Substance
DICLOFENAC POTASSIUM
Active strength
25 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 POTASSIUM25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL4D5UA6CB4
Rxcui858342

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
69315-275-20Diclofenac Potassium120 in 1 BOTTLECAPSULE, LIQUID FILLED1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-275-20EA - Each69315-27566c6ccfc-c59b-4b55-a0cb-0797a554848112022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-275DICLOFENAC POTASSIUM CAPSULE, LIQUID FILLED [LEADING PHARMA, LLC]2Current NDC, Legacy NDC, 1 package rows20250317_698690a7-4978-4457-b123-0a670bbab481.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858342diclofenac potassium 25 MG Oral CapsulePSN698690a7-4978-4457-b123-0a670bbab4812
858342diclofenac 25 MG Oral CapsuleSCD698690a7-4978-4457-b123-0a670bbab4812
858342diclofenac 25 MG (equivalent to diclofenac potassium 28.3 MG) Oral CapsuleSY698690a7-4978-4457-b123-0a670bbab4812
858342diclofenac potassium 25 MG Oral CapsulePSN69ab6f91-5770-480c-8bd1-8c1f1f8bfdb51
858342diclofenac 25 MG Oral CapsuleSCD69ab6f91-5770-480c-8bd1-8c1f1f8bfdb51
858342diclofenac 25 MG (equivalent to diclofenac potassium 28.3 MG) Oral CapsuleSY69ab6f91-5770-480c-8bd1-8c1f1f8bfdb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69315-275-2069315027520120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69315-275-20) 2022-03-240000-00-00NoNoCurrent