FDA.reportPublic FDA data

24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

RxCUI
1593070
RxNorm name
24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
Display name
24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
Full name
24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
Term type
SCD
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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dapagliflozin and Metformin HydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.54027b70-53e7-3710-e063-6394a90aa04c2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593070
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDELupin Pharmaceuticals, Inc.e6957674-86c1-4536-8e23-54ad7f2cacc42026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593070
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLC4f890458-be94-4baf-b606-83a097e1e23e2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593070
Dapagliflozin and Metformin hydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAurobindo Pharma Limited513bdf9f-774c-4f7f-935a-54d3885e80a42026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593070
Dapagliflozin and Metformin HydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEMacleods Pharmaceuticals Limited7d575ca8-9c1f-469d-a341-34daf2f036dd2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593070
Dapagliflozin and Metformin HydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.bddc2d47-8d3d-4c2f-8e5c-7a1a0782219a2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593070
dapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAscend Laboratories, LLCeadcc3ef-f5c2-4a56-a6aa-12909844144e2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593070
dapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEPrasco Laboratorieseaf135b6-e378-4f62-a1e7-db45e23668c72024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593070

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
ac8a0f7b-9f69-4495-abbc-3a47cd75a859dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR 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 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR 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 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR 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
eaf135b6-e378-4f62-a1e7-db45e23668c7dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet [SY]37These 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: 201420241220
bddc2d47-8d3d-4c2f-8e5c-7a1a0782219adapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet [SY]32These 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
4f890458-be94-4baf-b606-83a097e1e23edapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR 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 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR 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 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR 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