FDA.reportPublic FDA data

esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet

RxCUI
994005
RxNorm name
esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet
Display name
esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet
Full name
esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.65b892f2-8385-4bb0-8121-a58b01e8d13d2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 994005
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMAjanta Pharma USA Inc.7ca657dc-4376-4693-8568-99351fac81862025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 994005
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc470496f5-a71d-40b2-bf11-3a8d3d7909622025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 994005
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPHOENIX RX LLC3a6637ca-0c55-f648-e063-6294a90aaef72025-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 994005
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMScieGen Pharmaceuticals, Inc167340c2-1234-4d00-b4e2-cccf3d270fda2025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 994005
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMAsclemed USA, Inc.7b3af5a8-0c92-43f4-af13-7a47dca20e922024-12-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 994005
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Limited1ef3fe94-9bbb-934d-a09b-d19a1d23a4d52024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 994005

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 7 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
1ef3fe94-9bbb-934d-a09b-d19a1d23a4d5naproxen 375 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet [PSN] · esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral Tablet [SCD] · esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet [SY]320These highlights do not include all the information needed to use NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS. NAPROXEN AND ESOMEPRAZOLE MAGNESIUM delayed-release tablets, for oral use Initial U.S. Approval: 201020241220
7ca657dc-4376-4693-8568-99351fac8186naproxen 375 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet [PSN] · esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral Tablet [SCD] · esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet [SY]310These highlights do not include all the information needed to use NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS. NAPROXEN AND ESOMEPRAZOLE MAGNESIUM delayed-release tablets, for oral use Initial U.S. Approval: 201020251223
167340c2-1234-4d00-b4e2-cccf3d270fdanaproxen 375 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet [PSN] · esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral Tablet [SCD] · esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet [SY]33These highlights do not include all the information needed to use NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS. NAPROXEN AND ESOMEPRAZOLE MAGNESIUM delayed-release tablets, for oral use Initial U.S. Approval: 201020250306
470496f5-a71d-40b2-bf11-3a8d3d790962naproxen 375 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet [PSN] · esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral Tablet [SCD] · esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet [SY]31These highlights do not include all the information needed to use NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS. NAPROXEN AND ESOMEPRAZOLE MAGNESIUM delayed-release tablets, for oral use Initial U.S. Approval: 201020250731
3a6637ca-0c55-f648-e063-6294a90aaef7naproxen 375 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet [PSN] · esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral Tablet [SCD] · esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet [SY]31These highlights do not include all the information needed to use NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS. NAPROXEN and ESOMEPRAZOLE MAGNESIUM delayed-release tablets, for oral use Initial U.S. Approval: 201020250720
7b3af5a8-0c92-43f4-af13-7a47dca20e92naproxen 375 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet [PSN] · esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral Tablet [SCD] · esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet [SY]31These highlights do not include all the information needed to use NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS. NAPROXEN AND ESOMEPRAZOLE MAGNESIUM delayed-release tablets, for oral use Initial U.S. Approval: 201020241228
9513589d-ef5d-4b8d-a90a-6adb6af2ae11naproxen 375 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet [PSN] · esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral Tablet [SCD] · esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet [SY]31These highlights do not include all the information needed to use VIMOVO safely and effectively. See full prescribing information for VIMOVO. VIMOVO ® (naproxen and esomeprazole magnesium) DELAYED RELEASE TABLETS Initial U.S. Approval: April 201020110729