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
UNII Substances#
No records found.
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 1593072 |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Novadoz Pharmaceuticals LLC | 4f890458-be94-4baf-b606-83a097e1e23e | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 1593072 |
| Dapagliflozin and Metformin hydrochloride | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 1593072 |
| Dapagliflozin and Metformin Hydrochloride | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 7d575ca8-9c1f-469d-a341-34daf2f036dd | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 1593072 |
| dapagliflozin and metformin hydrochloride | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Ascend Laboratories, LLC | eadcc3ef-f5c2-4a56-a6aa-12909844144e | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | 1593072 |
| XIGDUO XR | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | AstraZeneca Pharmaceuticals LP | ac8a0f7b-9f69-4495-abbc-3a47cd75a859 | 2024-12-20 | Boxed warning, Warnings, Adverse reactions | 1593072 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| ac8a0f7b-9f69-4495-abbc-3a47cd75a859 | dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet | SY | 38 | These 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: 2014 | 20241220 |
| ac8a0f7b-9f69-4495-abbc-3a47cd75a859 | 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | 38 | These 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: 2014 | 20241220 |
| ac8a0f7b-9f69-4495-abbc-3a47cd75a859 | dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet | PSN | 38 | These 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: 2014 | 20241220 |
| e6957674-86c1-4536-8e23-54ad7f2cacc4 | 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | 15 | These 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: 2014 | 20260421 |
| e6957674-86c1-4536-8e23-54ad7f2cacc4 | dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet | PSN | 15 | These 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: 2014 | 20260421 |
| e6957674-86c1-4536-8e23-54ad7f2cacc4 | dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet | SY | 15 | These 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: 2014 | 20260421 |
| eadcc3ef-f5c2-4a56-a6aa-12909844144e | dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet | SY | 14 | These 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: 2014 | 20260318 |
| eadcc3ef-f5c2-4a56-a6aa-12909844144e | 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | 14 | These 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: 2014 | 20260318 |
| eadcc3ef-f5c2-4a56-a6aa-12909844144e | dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet | PSN | 14 | These 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: 2014 | 20260318 |
| 4f890458-be94-4baf-b606-83a097e1e23e | dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet | PSN | 1 | These 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: 2014 | 20260409 |
| 4f890458-be94-4baf-b606-83a097e1e23e | 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | 1 | These 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: 2014 | 20260409 |
| 4f890458-be94-4baf-b606-83a097e1e23e | dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet | SY | 1 | These 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: 2014 | 20260409 |
| 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | 1 | These 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: 2014 | 20260407 |
| 513bdf9f-774c-4f7f-935a-54d3885e80a4 | dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet | SY | 1 | These 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: 2014 | 20260407 |
| 513bdf9f-774c-4f7f-935a-54d3885e80a4 | dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet | PSN | 1 | These 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: 2014 | 20260407 |
| 7d575ca8-9c1f-469d-a341-34daf2f036dd | dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet | PSN | 1 | These 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: 2014 | 20260331 |
| 7d575ca8-9c1f-469d-a341-34daf2f036dd | dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet | SY | 1 | These 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: 2014 | 20260331 |
| 7d575ca8-9c1f-469d-a341-34daf2f036dd | 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | 1 | These 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: 2014 | 20260331 |