Diclofenac Sodium

Product NDC
33358-451
11-digit product format
333580451
Labeler code
33358
Product ID
33358-451_fb0dcb02-f3ac-4d81-9036-3896ea929348
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
RxChange Co.
Application
NDA020254
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-11-26
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33358-451IInactivated by FDA2026-09-09
excluded packagepackage33358-45133358-451-30IInactivated by FDA2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33358-451-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33358-451-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33358-451-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33358-451-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33358-451-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33358-451-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33358-451-30IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33358-451-30IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33358-451-30IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33358-451-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33358-451-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33358-451-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33358-451-30IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33358-451-30IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33358-451-30IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33358-451-30IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33358-451-30IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33358-451-30IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33358-451-30IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33358-451-30IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage33358-451-30IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage33358-451-30EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020254-001VOLTAREN-XRDICLOFENAC SODIUM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020254-001VOLTAREN-XR100MGTABLET, EXTENDED RELEASE / ORALRLD1996-03-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020254-001VOLTAREN-XR100MGTABLET, EXTENDED RELEASE / ORALRLD1996-03-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-083f01610625f2…
2019-09-15 20:21 UTC2019-09N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08e64feba35796…

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
33358-451-302020-01-31C16284748780-19d75b9d0-0ebf-f424-e053-dadaa90a57ceDiclofenac Sodium Extended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33358-451-30Diclofenac Sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33358-451-30EA - Each33358-45122e79c2e-4bd0-468c-9503-66672b3bb22412015-03-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33358-451DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2Legacy NDC, 1 package rows20141202_01e92b73-8271-4028-8a74-c236e3b55db8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN01e92b73-8271-4028-8a74-c236e3b55db82
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD01e92b73-8271-4028-8a74-c236e3b55db82
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY01e92b73-8271-4028-8a74-c236e3b55db82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33358-451-303335804513030 in 1 BOTTLEHistorical