FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
80425-0564
11-digit product format
804250564
Labeler code
80425
Product ID
80425-0564_4539e7df-c6cc-0550-e063-6294a90a0a2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA075185
Marketing category
ANDA
Marketing start
2025-12-05
Substance
DICLOFENAC SODIUM
Active strength
75 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 Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855926

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
80425-0564-1Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE301
80425-0564-2Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE601
80425-0564-3Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0564-1EA - Each80425-05646ac4fc53-ae79-4518-b4e6-54fd7f1d735912026-01-08
80425-0564-2EA - Each80425-056467c3d741-32a3-4e73-a376-661b8877acc912026-01-08
80425-0564-3EA - Each80425-05643f163bd1-761d-48d9-b976-7a3a508527a412026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN4539e9e7-5d82-3b36-e063-6394a90a13961
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD4539e9e7-5d82-3b36-e063-6394a90a13961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0564-18042505640130 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0564-1) 2025-12-05NoNoHistorical
80425-0564-28042505640260 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0564-2) 2025-12-05NoNoHistorical
80425-0564-38042505640390 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0564-3) 2025-12-05NoNoHistorical