FDA.reportPublic FDA data

Xigduo XR 5/500 24HR Extended Release Oral Tablet

RxCUI
1593831
RxNorm name
Xigduo XR 5/500 24HR Extended Release Oral Tablet
Display name
Xigduo XR 5/500 24HR Extended Release Oral Tablet
Full name
Xigduo XR 5/500 24HR Extended Release Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:15

RxNav Current And Historical NDCs#

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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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XIGDUO XRDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAstraZeneca Pharmaceuticals LPac8a0f7b-9f69-4495-abbc-3a47cd75a8592026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593831

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ac8a0f7b-9f69-4495-abbc-3a47cd75a859Xigduo XR 5/500 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Xigduo] [SBD] · Xigduo XR 5/500 24HR Extended Release Oral Tablet [SY]338These highlights do not include all the information needed to use XIGDUO XR safely and effectively. See full prescribing information for XIGDUO XR. XIGDUO ® XR (dapagliflozin and metformin hydrochloride extended-release) tablets, for oral use Initial U.S. Approval: 201420241220