Diclofenac Sodium

Product NDC
50090-1769
11-digit product format
500901769
Labeler code
50090
Product ID
50090-1769_bb2ff34b-154a-47a6-846b-130dd8ae54f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074514
Marketing category
ANDA
Marketing start
1996-03-26
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
75 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
50090-1769-02026-01-15C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information
50090-1769-12026-01-15C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information
50090-1769-22026-01-15C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information
50090-1769-32026-01-15C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information
50090-1769-42026-01-15C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information
50090-1769-82026-01-15C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information
50090-1769-92026-01-15C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information
50090-1769-02023-01-30C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information
50090-1769-12023-01-30C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information
50090-1769-22023-01-30C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information
50090-1769-32023-01-30C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information
50090-1769-42023-01-30C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information
50090-1769-82023-01-30C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information
50090-1769-92023-01-30C16284748780-1f386c64a-1d35-0266-e053-dadaa90a7c1aDiclofenac Sodium Delayed-Release Tablets, USP Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1769-0Diclofenac Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10029
50090-1769-1Diclofenac Sodium20 in 1 BOTTLETABLET, DELAYED RELEASE2029
50090-1769-2Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3029
50090-1769-3Diclofenac Sodium14 in 1 BOTTLETABLET, DELAYED RELEASE1429
50090-1769-4Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE6029
50090-1769-8Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9029
50090-1769-9Diclofenac Sodium180 in 1 BOTTLETABLET, DELAYED RELEASE18029

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1769DICLOFENAC SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]27Legacy NDC, 7 package rows20210611_47793dca-5e9e-44ee-8e66-5e42e1831b1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN47793dca-5e9e-44ee-8e66-5e42e1831b1e29
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN47793dca-5e9e-44ee-8e66-5e42e1831b1e29
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD47793dca-5e9e-44ee-8e66-5e42e1831b1e29
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD47793dca-5e9e-44ee-8e66-5e42e1831b1e29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1769-050090176900100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-1769-0) 2015-04-070000-00-00NoNoCurrent
50090-1769-15009017690120 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-1769-1) 2015-04-070000-00-00NoNoCurrent
50090-1769-25009017690230 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-1769-2) 2015-04-070000-00-00NoNoCurrent
50090-1769-35009017690314 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-1769-3) 2015-04-070000-00-00NoNoCurrent
50090-1769-45009017690460 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-1769-4) 2015-04-070000-00-00NoNoCurrent
50090-1769-85009017690890 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-1769-8) 2015-07-170000-00-00NoNoCurrent
50090-1769-950090176909180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-1769-9) 2019-08-050000-00-00NoNoCurrent