FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
69292-550
11-digit product format
692920550
Labeler code
69292
Product ID
69292-550_cf4973de-8da2-4fdf-8f48-938627e09d5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amici Pharma Inc.
Application
ANDA076561
Marketing category
ANDA
Marketing start
2020-12-11
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, 857702

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69292-550-012023-05-25C16284748780-1f386c649-ecac-0266-e053-dadaa90a7c1aDiclofenac Potassium Tablets, USP 50mg
69292-550-012023-01-30C16284748780-1f386c649-ecac-0266-e053-dadaa90a7c1aDiclofenac Potassium Tablets, USP 50mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69292-550-01Diclofenac Potassium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-550-01EA - Each69292-5509bdc31c0-f774-4c26-9e31-e3d162547d6212021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69292-550DICLOFENAC POTASSIUM TABLET, FILM COATED [AMICI PHARMA INC.]8Current NDC, Legacy NDC, 1 package rows20250406_f2908870-a517-491f-8771-4100d11b4b64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857702diclofenac potassium 25 MG Oral TabletPSNf2908870-a517-491f-8771-4100d11b4b649
855942diclofenac potassium 50 MG Oral TabletPSNf2908870-a517-491f-8771-4100d11b4b649
857702diclofenac potassium 25 MG Oral TabletSCDf2908870-a517-491f-8771-4100d11b4b649
855942diclofenac potassium 50 MG Oral TabletSCDf2908870-a517-491f-8771-4100d11b4b649
857702Diclofenac K+ 25 MG Oral TabletSYf2908870-a517-491f-8771-4100d11b4b649
855942Diclofenac K+ 50 MG Oral TabletSYf2908870-a517-491f-8771-4100d11b4b649
857702Diclofenac Pot 25 MG Oral TabletSYf2908870-a517-491f-8771-4100d11b4b649
855942Diclofenac Pot 50 MG Oral TabletSYf2908870-a517-491f-8771-4100d11b4b649
855942diclofenac potassium 50 MG Oral TabletPSNc2c79af6-f35e-5cdf-e053-2a95a90a4d636
855942diclofenac potassium 50 MG Oral TabletSCDc2c79af6-f35e-5cdf-e053-2a95a90a4d636
855942Diclofenac K+ 50 MG Oral TabletSYc2c79af6-f35e-5cdf-e053-2a95a90a4d636
855942Diclofenac Pot 50 MG Oral TabletSYc2c79af6-f35e-5cdf-e053-2a95a90a4d636

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69292-550-0169292055001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69292-550-01) 2020-12-110000-00-00NoNoCurrent