24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet
- RxCUI
- 1593072
- RxNorm name
- 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet
- Display name
- Dapagliflozin/metFORMIN XR (Oral Pill)
- Full name
- 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet
- Term type
- SCD
- Status
- Active
- Strength
- 5-500 mg
- Dose form
- 24 HR XR Tab
- Route
- Oral Pill
- Updated
- 2026-10-15 14:49:21
RxNorm Status History#
- Status
- Active
- Source
- RXNORM
- Current
- YES
- Release start
- 122014
- Active start
- 122014
- Multiple ingredient
- YES
- Branded
- NO
Ingredients And Strength#
| Ingredient | Strength | Base | Basis of strength |
|---|---|---|---|
| dapagliflozin propanediol | 5 MG / 1 EACH | dapagliflozin | dapagliflozin |
| metformin hydrochloride | 500 MG / 1 EACH | metformin | metformin hydrochloride |
Dose Form Concepts#
| Dose form | RxCUI |
|---|---|
| Extended Release Oral Tablet | 316945 |
Derived Ingredient Concepts#
| Ingredient | RxCUI |
|---|---|
| dapagliflozin | 1488564 |
| metformin | 6809 |
Source Vocabulary Codes#
| Code type | Values | Count | Category |
|---|---|---|---|
| PRESCRIBABLE | Y | 1 | ATTRIBUTES |
| RXNAV_STR | 24 HR dapagliflozin 5 MG / metFORMIN hydrochloride 500 MG Extended Release Oral Tablet | 1 | NAMES |
| RxNorm Name | 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet | 1 | NAMES |
| RxNorm Synonym | dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet | 1 | NAMES |
| TTY | SCD | 1 | ATTRIBUTES |
| SPL_SET_ID | 5 | CODES | |
| RxCUI | 1593072 | 1 | CODES |
| MMSL_CODE | 2 | CODES |
FDA NDC Products And Packages#
| Package NDC | Product NDC | Name | Labeler | Application |
|---|---|---|---|---|
| 33342-406-06 | 33342-406 | Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride | Macleods Pharmaceuticals Limited | ANDA211559 |
| 33342-406-07 | 33342-406 | Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride | Macleods Pharmaceuticals Limited | ANDA211559 |
| 33342-406-09 | 33342-406 | Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride | Macleods Pharmaceuticals Limited | ANDA211559 |
| 33342-406-10 | 33342-406 | Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride | Macleods Pharmaceuticals Limited | ANDA211559 |
| 33342-406-15 | 33342-406 | Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride | Macleods Pharmaceuticals Limited | ANDA211559 |
| 59651-154-05 | 59651-154 | Dapagliflozin and Metformin hydrochloride Dapagliflozin and Metformin hydrochloride | Aurobindo Pharma Limited | ANDA211489 |
| 59651-154-30 | 59651-154 | Dapagliflozin and Metformin hydrochloride Dapagliflozin and Metformin hydrochloride | Aurobindo Pharma Limited | ANDA211489 |
| 67877-619-05 | 67877-619 | dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochloride | Ascend Laboratories, LLC | ANDA211563 |
| 67877-619-30 | 67877-619 | dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochloride | Ascend Laboratories, LLC | ANDA211563 |
| 70748-101-06 | 70748-101 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA211579 |
| 72205-434-01 | 72205-434 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Novadoz Pharmaceuticals LLC | ANDA211479 |
| 72205-434-02 | 72205-434 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Novadoz Pharmaceuticals LLC | ANDA211479 |
Drugs@FDA Applications#
| Application | NDC | Name | Marketing category | Labeler |
|---|---|---|---|---|
| ANDA211559 | 33342-406 | Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin Hydrochloride | ANDA | Macleods Pharmaceuticals Limited |
| ANDA211489 | 59651-154 | Dapagliflozin and Metformin hydrochloride Dapagliflozin and Metformin hydrochloride | ANDA | Aurobindo Pharma Limited |
| ANDA211563 | 67877-619 | dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochloride | ANDA | Ascend Laboratories, LLC |
| ANDA211579 | 70748-101 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | ANDA | Lupin Pharmaceuticals, Inc. |
| ANDA211479 | 72205-434 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | ANDA | Novadoz Pharmaceuticals LLC |
UNII Substances#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| XIGDUO XR | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | AstraZeneca Pharmaceuticals LP | ac8a0f7b-9f69-4495-abbc-3a47cd75a859 | 2026-08-11 | 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 | 72205-434-02 72205-434-01 72205-434 72205043402 72205043401 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 | 67877-619-30 67877-619-05 67877-619 67877061930 67877061905 1593072 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| ac8a0f7b-9f69-4495-abbc-3a47cd75a859 | dapagliflozin 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] | 3 | 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 | dapagliflozin 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] | 3 | 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 [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] | 3 | 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] · 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] | 3 | 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 | dapagliflozin 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] | 3 | 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] · 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] | 3 | 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 |
Recently Linked DailyMed Labels#
| Set ID | Title | Manufacturer | Effective |
|---|---|---|---|
| 7d575ca8-9c1f-469d-a341-34daf2f036dd | 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 | Macleods Pharmaceuticals Limited | 20260916 |
| e6957674-86c1-4536-8e23-54ad7f2cacc4 | 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20260908 |
| 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 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 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20260902 |
| e6957674-86c1-4536-8e23-54ad7f2cacc4 | 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20260421 |
| 4f890458-be94-4baf-b606-83a097e1e23e | 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 | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | 20260409 |
| 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 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 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20260407 |
| 7d575ca8-9c1f-469d-a341-34daf2f036dd | 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 | Macleods Pharmaceuticals Limited | 20260331 |
| eadcc3ef-f5c2-4a56-a6aa-12909844144e | 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 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20260318 |
Drug Classes#
| Source | Class ID | Class | Type | Relationship | Drug concept |
|---|---|---|---|---|---|
| ATC | A10BA | Biguanides | ATC1-4 | metformin | |
| ATC | A10BD | Combinations of oral blood glucose lowering drugs | ATC1-4 | dapagliflozin / metformin | |
| ATC | A10BK | Sodium-glucose co-transporter 2 (SGLT2) inhibitors | ATC1-4 | dapagliflozin | |
| FDASPL | D001645 | Biguanides | CHEM | has_chemical_structure | metformin |
| FDASPL | N0000175565 | Biguanide | EPC | has_epc | metformin |
| FDASPL | N0000187059 | Sodium-Glucose Cotransporter 2 Inhibitor | EPC | has_epc | dapagliflozin |
| FDASPL | N0000187058 | Sodium-Glucose Transporter 2 Inhibitors | MOA | has_moa | dapagliflozin |
| MEDRT | D001559 | Benzhydryl Compounds | CHEM | has_ingredient | dapagliflozin |
| MEDRT | D005960 | Glucosides | CHEM | has_ingredient | dapagliflozin |
| MEDRT | D008687 | Metformin | CHEM | has_ingredient | metformin |
| MEDRT | D008687 | Metformin | CHEM | has_ingredient | metformin hydrochloride |
| MEDRT | D000138 | Acidosis | DISEASE | ci_with | metformin hydrochloride |
| MEDRT | D000138 | Acidosis | DISEASE | ci_with | metformin |
| MEDRT | D003924 | Diabetes Mellitus, Type 2 | DISEASE | may_treat | metformin |
| MEDRT | D003924 | Diabetes Mellitus, Type 2 | DISEASE | may_treat | dapagliflozin |
| MEDRT | D003924 | Diabetes Mellitus, Type 2 | DISEASE | may_treat | metformin hydrochloride |
| MEDRT | D016883 | Diabetic Ketoacidosis | DISEASE | ci_with | metformin |
| MEDRT | D016883 | Diabetic Ketoacidosis | DISEASE | ci_with | metformin hydrochloride |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | metformin hydrochloride |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | metformin |
| MEDRT | D006333 | Heart Failure | DISEASE | may_treat | dapagliflozin |
| MEDRT | D008107 | Liver Diseases | DISEASE | ci_with | metformin hydrochloride |
| MEDRT | D008107 | Liver Diseases | DISEASE | ci_with | metformin |
| MEDRT | D051437 | Renal Insufficiency | DISEASE | ci_with | metformin hydrochloride |
| MEDRT | D051437 | Renal Insufficiency | DISEASE | ci_with | metformin |
| MEDRT | N0000000225 | Insulin Receptor Agonists | MOA | has_moa | metformin |
| MEDRT | N0000000225 | Insulin Receptor Agonists | MOA | has_moa | metformin hydrochloride |
| MEDRT | N0000187058 | Sodium-Glucose Transporter 2 Inhibitors | MOA | has_moa | dapagliflozin |
| MEDRT | N0000008646 | Decreased Gluconeogenesis | PE | has_pe | metformin hydrochloride |
| MEDRT | N0000008646 | Decreased Gluconeogenesis | PE | has_pe | metformin |
| MEDRT | N0000008650 | Decreased Glycogenesis | PE | has_pe | metformin |
| MEDRT | N0000008650 | Decreased Glycogenesis | PE | has_pe | metformin hydrochloride |
| MEDRT | N0000175650 | Decreased Sympathetic Activity | PE | has_pe | dapagliflozin |
| MEDRT | N0000009341 | Increased Glucose Transport into Cells | PE | has_pe | metformin hydrochloride |
| MEDRT | N0000009341 | Increased Glucose Transport into Cells | PE | has_pe | metformin |
| MEDRT | N0000009556 | Increased Renal Organic Ion Excretion | PE | has_pe | dapagliflozin |
| MEDRT | N0000009830 | Renal Ion Transport Alteration | PE | has_pe | dapagliflozin |
| MEDRT | N0000000042 | Renal Excretion | PK | has_pk | metformin |
| MEDRT | N0000000042 | Renal Excretion | PK | has_pk | metformin hydrochloride |
Properties#
| Category | Property | Value |
|---|---|---|
| ATTRIBUTES | AVAILABLE_STRENGTH | 5 MG / 500 MG |
| ATTRIBUTES | GENERAL_CARDINALITY | MULTI |
| ATTRIBUTES | HUMAN_DRUG | US |
| ATTRIBUTES | QUANTITY | 24 HR |
| ATTRIBUTES | RXNAV_HUMAN_DRUG | US |
| ATTRIBUTES | SCHEDULE | 0 |
| CODES | ANDA | ANDA211479 |
| CODES | ANDA | ANDA211489 |
| CODES | ANDA | ANDA211559 |
| CODES | ANDA | ANDA211563 |
| CODES | ANDA | ANDA211579 |
| CODES | VUID | 4033846 |
| NAMES | Prescribable Synonym | dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet |
| NAMES | Tallman Synonym | 24 HR dapagliflozin 5 MG / metFORMIN hydrochloride 500 MG Extended Release Oral Tablet |
| NAMES | Tallman Synonym | dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet |
| SOURCES | Source | Gold Standard Alchemy |
| SOURCES | Source | Metathesaurus FDA Structured Product Labels |
| SOURCES | Source | Micromedex RED BOOK |
| SOURCES | Source | Multum MediSource Lexicon |
| SOURCES | Source | National Drug Data File Plus Source Vocabulary |
| SOURCES | Source | Veterans Health Administration National Drug File |