FDA.reportPublic FDA data

diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet [Arthrotec]

RxCUI
1359109
RxNorm name
diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet [Arthrotec]
Display name
diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet [Arthrotec]
Full name
diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet [Arthrotec]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:00

RxNav Current And Historical NDCs#

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UNII Substances#

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No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARTHROTECDICLOFENAC SODIUM AND MISOPROSTOLPfizer Laboratories Div Pfizer Inc600fe842-45d9-4d68-9ef2-456dbbebaa112025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359109

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
600fe842-45d9-4d68-9ef2-456dbbebaa11diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet [Arthrotec]SBD38These highlights do not include all the information needed to use ARTHROTEC safely and effectively. See full prescribing information for ARTHROTEC. ARTHROTEC ® (diclofenac sodium and misoprostol delayed-release tablets), for oral use Initial U.S. Approval:199720250814
600fe842-45d9-4d68-9ef2-456dbbebaa11Arthrotec 75 MG / 200 MCG Delayed Release Oral TabletPSN38These highlights do not include all the information needed to use ARTHROTEC safely and effectively. See full prescribing information for ARTHROTEC. ARTHROTEC ® (diclofenac sodium and misoprostol delayed-release tablets), for oral use Initial U.S. Approval:199720250814
600fe842-45d9-4d68-9ef2-456dbbebaa11Arthrotec (diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG) Delayed Release Oral TabletSY38These highlights do not include all the information needed to use ARTHROTEC safely and effectively. See full prescribing information for ARTHROTEC. ARTHROTEC ® (diclofenac sodium and misoprostol delayed-release tablets), for oral use Initial U.S. Approval:199720250814
4f0a7109-2915-4daa-a752-8f78cf040b37Arthrotec 75 MG / 200 MCG Delayed Release Oral TabletPSN5ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets20120117
4f0a7109-2915-4daa-a752-8f78cf040b37diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet [Arthrotec]SBD5ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets20120117
4f0a7109-2915-4daa-a752-8f78cf040b37Arthrotec (diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG) Delayed Release Oral TabletSY5ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets20120117
bdf17a90-9444-4dba-aff6-df27e07f23d5Arthrotec (diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG) Delayed Release Oral TabletSY1ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets20120613
bdf17a90-9444-4dba-aff6-df27e07f23d5diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet [Arthrotec]SBD1ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets20120613
bdf17a90-9444-4dba-aff6-df27e07f23d5Arthrotec 75 MG / 200 MCG Delayed Release Oral TabletPSN1ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets20120613
1cdede45-4e2b-490a-bd22-eca5315af316Arthrotec 75 MG / 200 MCG Delayed Release Oral TabletPSN1ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets20091110
1cdede45-4e2b-490a-bd22-eca5315af316Arthrotec (diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG) Delayed Release Oral TabletSY1ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets20091110
1cdede45-4e2b-490a-bd22-eca5315af316diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet [Arthrotec]SBD1ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets20091110