FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
50436-0676
11-digit product format
504360676
Labeler code
50436
Product ID
50436-0676_9f5f695d-8a2f-4cbe-a15f-2d37d3d2c585
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA076201
Marketing category
ANDA
Marketing start
2002-11-06
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
100 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
2019-12-31
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
50436-0676-12020-01-31C16284748780-19d75b9d0-6de7-f424-e053-dadaa90a57ceDiclofenac Sodium Extended-release Tablets
50436-0676-22020-01-31C16284748780-19d75b9d0-6de7-f424-e053-dadaa90a57ceDiclofenac Sodium Extended-release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0676-1Diclofenac Sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
50436-0676-2Diclofenac Sodium60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0676-1EA - Each50436-06768e4b3e48-a164-47c4-a9ea-b19f0b52b23212017-08-11
50436-0676-2EA - Each50436-06761c142212-8e07-4cb0-92b1-d9900a9cea0f12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0676DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [UNIT DOSE SERVICES]1Legacy NDC, 2 package rows20160803_d3688090-07ca-4802-a865-60843b0d83ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNd3688090-07ca-4802-a865-60843b0d83ab1
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDd3688090-07ca-4802-a865-60843b0d83ab1
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYd3688090-07ca-4802-a865-60843b0d83ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0676-15043606760130 in 1 BOTTLEHistorical
50436-0676-25043606760260 in 1 BOTTLEHistorical