FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
73352-086
11-digit product format
733520086
Labeler code
73352
Product ID
73352-086_e1409a25-9dd7-4c50-ae45-7dbaee133125
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Trifluent Pharma LLC
Application
ANDA075229
Marketing category
ANDA
Marketing start
2023-02-17
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
Rxcui857702

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
73352-086-30Diclofenac Potassium30 in 1 BOTTLETABLET, COATED3014
73352-086-60Diclofenac Potassium60 in 1 BOTTLETABLET, COATED6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-086-30EA - Each73352-0861d236f60-30ee-4fa4-a728-f16c8b7d08b312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73352-086DICLOFENAC POTASSIUM TABLET, COATED [TRIFLUENT PHARMA LLC]13Current NDC, 2 package rows20241122_8fdb1036-c0d8-4288-ac37-6512b05672ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857702diclofenac potassium 25 MG Oral TabletPSN8fdb1036-c0d8-4288-ac37-6512b05672ef14
857702diclofenac potassium 25 MG Oral TabletSCD8fdb1036-c0d8-4288-ac37-6512b05672ef14
857702Diclofenac K+ 25 MG Oral TabletSY8fdb1036-c0d8-4288-ac37-6512b05672ef14
857702Diclofenac Pot 25 MG Oral TabletSY8fdb1036-c0d8-4288-ac37-6512b05672ef14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73352-086-307335200863030 TABLET, COATED in 1 BOTTLE (73352-086-30) 2023-02-17NoNoCurrent
73352-086-607335200866060 TABLET, COATED in 1 BOTTLE (73352-086-60) 2023-09-25NoNoCurrent