FDA.reportPublic FDA data

Diclofenac Sodium Delayed Release

Product NDC
50090-0543
11-digit product format
500900543
Labeler code
50090
Product ID
50090-0543_02eb3aca-0433-4c56-818d-cd8501244b84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075185
Marketing category
ANDA
Marketing start
1998-11-13
Substance
DICLOFENAC SODIUM
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 Sodium Delayed Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855906

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
50090-0543-02023-02-07C16284748780-1f386c64a-2ab1-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed Release
50090-0543-12023-02-07C16284748780-1f386c64a-2ab1-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed Release
50090-0543-02023-01-30C16284748780-1f386c64a-2ab1-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed Release
50090-0543-12023-01-30C16284748780-1f386c64a-2ab1-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed Release

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0543-0Diclofenac Sodium Delayed Release30 in 1 BOTTLETABLET, DELAYED RELEASE3019
50090-0543-1Diclofenac Sodium Delayed Release14 in 1 BOTTLETABLET, DELAYED RELEASE1419

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0543-1EA - Each50090-0543cb215267-1601-4eed-8e47-4f219032979b12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0543DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 2 package rows20231024_9df87100-acf5-4b46-93b4-067b470136bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN9df87100-acf5-4b46-93b4-067b470136bd19
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD9df87100-acf5-4b46-93b4-067b470136bd19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0543-05009005430030 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0543-0) 2014-11-28NoNoHistorical
50090-0543-15009005430114 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0543-1) 2014-11-280000-00-00NoNoCurrent