FDA.reportPublic FDA data

dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet

RxCUI
1593072
RxNorm name
dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet
Display name
dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet
Full name
dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:15

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDELupin Pharmaceuticals, Inc.e6957674-86c1-4536-8e23-54ad7f2cacc42026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593072
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLC4f890458-be94-4baf-b606-83a097e1e23e2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593072
Dapagliflozin and Metformin hydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAurobindo Pharma Limited513bdf9f-774c-4f7f-935a-54d3885e80a42026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593072
Dapagliflozin and Metformin HydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEMacleods Pharmaceuticals Limited7d575ca8-9c1f-469d-a341-34daf2f036dd2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593072
dapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAscend Laboratories, LLCeadcc3ef-f5c2-4a56-a6aa-12909844144e2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593072

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ac8a0f7b-9f69-4495-abbc-3a47cd75a859dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [SCD] · dapagliflozin 5 MG / metformin HCl 500 MG 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
e6957674-86c1-4536-8e23-54ad7f2cacc4dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [SCD] · dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet [SY]315These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 201420260421
eadcc3ef-f5c2-4a56-a6aa-12909844144edapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [SCD] · dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet [SY]314These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 201420260318
4f890458-be94-4baf-b606-83a097e1e23edapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [SCD] · dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet [SY]31These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HCL EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HCL EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 201420260409
513bdf9f-774c-4f7f-935a-54d3885e80a4dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [SCD] · dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet [SY]31These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 201420260407
7d575ca8-9c1f-469d-a341-34daf2f036dddapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [SCD] · dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet [SY]31These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 201420260331