FDA.reportPublic FDA data

DICLOFENAC POTASSIUM

Product NDC
69292-552
11-digit product format
692920552
Labeler code
69292
Product ID
69292-552_796bf62e-3eee-423f-9770-a2d436fe5064
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium, film coated
Dosage form
TABLET
Route
ORAL
Labeler
Amici Pharma, Inc
Application
ANDA215787
Marketing category
ANDA
Marketing start
2024-03-12
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
Rxcui855942

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
69292-552-01DICLOFENAC POTASSIUM100 in 1 BOTTLETABLET1002
69292-552-50DICLOFENAC POTASSIUM500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-552-01EA - Each69292-5522b731e66-6196-4a2e-b10c-460330581fc912024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69292-552DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM, FILM COATED) TABLET [AMICI PHARMACEUTICALS LLC]1Current NDC, 2 package rows20240314_c4ce1497-9cb1-4632-b1a2-4f61043c018d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN26d0ed73-b7a6-cbd8-e063-6394a90a9a312
855942diclofenac potassium 50 MG Oral TabletPSNc4ce1497-9cb1-4632-b1a2-4f61043c018d2
855942diclofenac potassium 50 MG Oral TabletSCD26d0ed73-b7a6-cbd8-e063-6394a90a9a312
855942diclofenac potassium 50 MG Oral TabletSCDc4ce1497-9cb1-4632-b1a2-4f61043c018d2
855942Diclofenac K+ 50 MG Oral TabletSY26d0ed73-b7a6-cbd8-e063-6394a90a9a312
855942Diclofenac K+ 50 MG Oral TabletSYc4ce1497-9cb1-4632-b1a2-4f61043c018d2
855942Diclofenac Pot 50 MG Oral TabletSY26d0ed73-b7a6-cbd8-e063-6394a90a9a312
855942Diclofenac Pot 50 MG Oral TabletSYc4ce1497-9cb1-4632-b1a2-4f61043c018d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69292-552-0169292055201100 TABLET in 1 BOTTLE (69292-552-01) 100 tablet2024-03-12NoNoCurrent
69292-552-5069292055250500 TABLET in 1 BOTTLE (69292-552-50) 500 tablet2024-03-12NoNoCurrent