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
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 | Golden State Medical Supply, Inc. | 54027b70-53e7-3710-e063-6394a90aa04c | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | 1593070 |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 1593070 |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Novadoz Pharmaceuticals LLC | 4f890458-be94-4baf-b606-83a097e1e23e | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 1593070 |
| Dapagliflozin and Metformin hydrochloride | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 1593070 |
| Dapagliflozin and Metformin Hydrochloride | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 7d575ca8-9c1f-469d-a341-34daf2f036dd | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 1593070 |
| Dapagliflozin and Metformin Hydrochloride | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | bddc2d47-8d3d-4c2f-8e5c-7a1a0782219a | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 1593070 |
| dapagliflozin and metformin hydrochloride | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Ascend Laboratories, LLC | eadcc3ef-f5c2-4a56-a6aa-12909844144e | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | 1593070 |
| dapagliflozin and metformin hydrochloride | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Prasco Laboratories | eaf135b6-e378-4f62-a1e7-db45e23668c7 | 2024-12-20 | Boxed warning, Warnings, Adverse reactions | 1593070 |
| XIGDUO XR | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | AstraZeneca Pharmaceuticals LP | ac8a0f7b-9f69-4495-abbc-3a47cd75a859 | 2024-12-20 | Boxed warning, Warnings, Adverse reactions | 1593070 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| ac8a0f7b-9f69-4495-abbc-3a47cd75a859 | dapagliflozin 5 MG / metFORMIN HCl 1000 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 |
| ac8a0f7b-9f69-4495-abbc-3a47cd75a859 | 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 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 (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR 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 |
| e6957674-86c1-4536-8e23-54ad7f2cacc4 | 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 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 1000 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 (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR 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 1000 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 |
| eadcc3ef-f5c2-4a56-a6aa-12909844144e | 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 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 (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR 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 |
| eaf135b6-e378-4f62-a1e7-db45e23668c7 | dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet | SY | 7 | 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 | 20241220 |
| eaf135b6-e378-4f62-a1e7-db45e23668c7 | 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet | SCD | 7 | 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 | 20241220 |
| eaf135b6-e378-4f62-a1e7-db45e23668c7 | dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet | PSN | 7 | 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 | 20241220 |
| bddc2d47-8d3d-4c2f-8e5c-7a1a0782219a | 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet | SCD | 2 | 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 |
| bddc2d47-8d3d-4c2f-8e5c-7a1a0782219a | dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet | SY | 2 | 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 |
| bddc2d47-8d3d-4c2f-8e5c-7a1a0782219a | dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet | PSN | 2 | 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 |
| 4f890458-be94-4baf-b606-83a097e1e23e | dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR 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 |
| 4f890458-be94-4baf-b606-83a097e1e23e | dapagliflozin 5 MG / metFORMIN HCl 1000 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 1000 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 |
| 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 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 (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR 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 1000 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 | 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 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 |
| 7d575ca8-9c1f-469d-a341-34daf2f036dd | dapagliflozin 5 MG / metFORMIN HCl 1000 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 (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR 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 |