VOLTAREN

Product NDC
61919-060
11-digit product format
619190060
Labeler code
61919
Product ID
61919-060_e9aa5eb4-e25c-1fd2-e053-2a95a90ac094
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICLOFENAC SODIUM D/R
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077863
Marketing category
ANDA
Marketing start
2016-05-04
Marketing end
0000-00-00
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
2023-12-31
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
61919-060-302025-01-30C16284748780-12cef2736-67b6-d83d-e063-dadaa90ab31fDICLOFENAC SODIUM D/R
61919-060-602025-01-30C16284748780-12cef2736-67b6-d83d-e063-dadaa90ab31fDICLOFENAC SODIUM D/R

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-060-30VOLTAREN30 in 1 BOTTLETABLET, DELAYED RELEASE303
61919-060-60VOLTAREN60 in 1 BOTTLETABLET, DELAYED RELEASE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-060-30EA - Each61919-0607d53149e-d99c-44bb-b2d7-a0193d5654b712022-10-06
61919-060-60EA - Each61919-0600dc019b8-27d2-48a5-b514-a78c10ef285012019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-060VOLTAREN (DICLOFENAC SODIUM D/R) TABLET, DELAYED RELEASE [DIRECT_RX]3Legacy NDC, 2 package rows20230401_32b988ec-61f9-603f-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-060-306191900603030 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-060-30) 2022-09-270000-00-00NoNoCurrent
61919-060-606191900606060 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-060-60) 2016-05-040000-00-00NoNoCurrent