FDA.reportPublic FDA data

DICLOFENAC SODIUM

Product NDC
61919-686
11-digit product format
619190686
Labeler code
61919
Product ID
61919-686_30627fe3-8721-7254-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DECLOFENAC SODIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077863
Marketing category
ANDA
Marketing start
2016-04-11
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
2020-12-31
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
61919-686-202024-01-30C16284748780-11030e365-0fa9-111a-e063-dadaa90a10e2DICLOFENAC SODIUM DR 75mg 20 TABS
61919-686-302024-01-30C16284748780-11030e365-1300-111a-e063-dadaa90a10e2DICLOFENAC SODIUM D\R 75mg 30 CAPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-686-20DICLOFENAC SODIUM20 in 1 BOTTLETABLET, DELAYED RELEASE201
61919-686-30DICLOFENAC SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-686-20EA - Each61919-6868a2b65d9-8392-445e-9ad4-78e5e5a85d4912019-04-11
61919-686-30EA - Each61919-6862b778d2e-9235-4581-909a-5a511a8bb80612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-686DICLOFENAC SODIUM (DECLOFENAC SODIUM) TABLET, DELAYED RELEASE [DIRECT RX]1Legacy NDC, 1 package rows20190405_3104cae3-5e36-6c6e-e054-00144ff88e88.zip
61919-686DICLOFENAC SODIUM (DECLOFENAC SODIUM) TABLET, DELAYED RELEASE [DIRECT RX]1Legacy NDC, 1 package rows20190426_30627fe3-8720-7254-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN30627fe3-8720-7254-e054-00144ff88e881
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN3104cae3-5e36-6c6e-e054-00144ff88e881
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD30627fe3-8720-7254-e054-00144ff88e881
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD3104cae3-5e36-6c6e-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-686-206191906862020 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-686-20) 2016-03-220000-00-00NoNoCurrent
61919-686-306191906863030 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-686-30) 2016-04-110000-00-00NoNoCurrent