FDA.reportPublic FDA data

diclofenac potassium

Product NDC
64380-841
11-digit product format
643800841
Labeler code
64380
Product ID
64380-841_79fcc2ee-be83-46d0-a8b1-1aacb0df6d4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA210078
Marketing category
ANDA
Marketing start
2022-09-20
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
64380-841-06diclofenac potassium100 in 1 BOTTLECAPSULE, LIQUID FILLED1009
64380-841-11diclofenac potassium120 in 1 BOTTLECAPSULE, LIQUID FILLED1209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-841DICLOFENAC POTASSIUM CAPSULE, LIQUID FILLED [STRIDES PHARMA SCIENCE LIMITED]9Current NDC, Legacy NDC, 2 package rows20250311_2184805c-b9b3-4be8-8726-4ce1b1197477.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858342diclofenac potassium 25 MG Oral CapsulePSN2184805c-b9b3-4be8-8726-4ce1b11974779
858342diclofenac 25 MG Oral CapsuleSCD2184805c-b9b3-4be8-8726-4ce1b11974779
858342diclofenac 25 MG (equivalent to diclofenac potassium 28.3 MG) Oral CapsuleSY2184805c-b9b3-4be8-8726-4ce1b11974779

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64380-841-0664380084106100 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-841-06) 2022-09-200000-00-00NoNoCurrent
64380-841-1164380084111120 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-841-11) 2024-12-28NoNoHistorical