FDA.reportPublic FDA data

naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet

RxCUI
1116320
RxNorm name
naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet
Display name
naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet
Full name
naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:25

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaprelanNAPROXEN SODIUMUpsher-Smith Laboratories, LLCb8a51c9a-488e-4377-a041-436f6a2f88932026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1116320
Naproxen SodiumNAPROXEN SODIUMUpsher-Smith Laboratories, LLC7c22a2d6-821c-4f83-aead-e756aed930e52025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1116320
Naproxen SodiumNAPROXEN SODIUMTeva Pharmaceuticals, Inc.826fd9e3-22fe-408b-820c-f2b7101895552024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1116320
Naproxen SodiumNAPROXEN SODIUMAlvogen Inc.9225acaa-209f-958b-2c51-9a46995dec332024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1116320
NaprelanNAPROXEN SODIUMAlmatica Pharma LLCe633ff0b-eab7-f167-8d08-e9236e54042b2024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1116320
Naproxen SodiumNAPROXEN SODIUMSA3, LLC313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d92019-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1116320

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 8 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
e633ff0b-eab7-f167-8d08-e9236e54042bnaproxen sodium 375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR naproxen 375 MG Extended Release Oral Tablet [SCD] · naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet [SY]318These highlights do not include all the information needed to use NAPRELAN ® safely and effectively. See full prescribing information for NAPRELAN ® . NAPRELAN (naproxen sodium) Controlled-Release Tablets, for oral use Initial U.S. Approval: 197620240715
9225acaa-209f-958b-2c51-9a46995dec33naproxen sodium 375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR naproxen 375 MG Extended Release Oral Tablet [SCD] · naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet [SY]311These highlights do not include all the information needed to use NAPROXEN SODIUM CONTROLLED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM CONTROLLED-RELEASE TABLETS . NAPROXEN SODIUM Controlled-Release Tablets, for oral use Initial U.S. Approval: 197620240715
826fd9e3-22fe-408b-820c-f2b710189555naproxen sodium 375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR naproxen 375 MG Extended Release Oral Tablet [SCD] · naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet [SY]36These highlights do not include all the information needed to use NAPROXEN SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM EXTENDED-RELEASE TABLETS . NAPROXEN SODIUM extended-release tablets, for oral use Initial U.S. Approval: 197620241230
7c22a2d6-821c-4f83-aead-e756aed930e5naproxen sodium 375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR naproxen 375 MG Extended Release Oral Tablet [SCD] · naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet [SY]33These highlights do not include all the information needed to use NAPROXEN SODIUM CONTROLLED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM CONTROLLED-RELEASE TABLETS . NAPROXEN SODIUM Controlled-Release Tablets, for oral use Initial U.S. Approval: 197620251201
b8a51c9a-488e-4377-a041-436f6a2f8893naproxen sodium 375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR naproxen 375 MG Extended Release Oral Tablet [SCD] · naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet [SY]32These highlights do not include all the information needed to use NAPRELAN ® safely and effectively. See full prescribing information for NAPRELAN ® . NAPRELAN (naproxen sodium) Controlled-Release Tablets, for oral use Initial U.S. Approval: 197620260108
313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d9naproxen sodium 375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR naproxen 375 MG Extended Release Oral Tablet [SCD] · naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet [SY]31These highlights do not include all the information needed to use NAPROXEN SODIUM CONTROLLED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM CONTROLLED-RELEASE TABLETS . NAPROXEN SODIUM Controlled-Release Tablets , for oral use Initial U.S. Approval: 197620190423
1f949140-68b5-4602-936f-1936e436d553naproxen sodium 375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR naproxen 375 MG Extended Release Oral Tablet [SCD] · naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet [SY]31NAPRELAN ® (naproxen sodium) CONTROLLED-RELEASE TABLETS20101229
a95509ce-49a8-4b2c-a533-27c322949bcanaproxen sodium 375 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR naproxen 375 MG Extended Release Oral Tablet [SCD] · naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet [SY]31NAPRELAN ® (naproxen sodium) CONTROLLED-RELEASE TABLETS20090801