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 table
IngredientStrengthBaseBasis of strength
dapagliflozin propanediol5 MG / 1 EACHdapagliflozindapagliflozin
metformin hydrochloride500 MG / 1 EACHmetforminmetformin hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Extended Release Oral Tablet316945

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
dapagliflozin1488564
metformin6809

Source Vocabulary Codes#

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
33342-406-0633342-406Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideMacleods Pharmaceuticals LimitedANDA211559
33342-406-0733342-406Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideMacleods Pharmaceuticals LimitedANDA211559
33342-406-0933342-406Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideMacleods Pharmaceuticals LimitedANDA211559
33342-406-1033342-406Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideMacleods Pharmaceuticals LimitedANDA211559
33342-406-1533342-406Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideMacleods Pharmaceuticals LimitedANDA211559
59651-154-0559651-154Dapagliflozin and Metformin hydrochloride Dapagliflozin and Metformin hydrochlorideAurobindo Pharma LimitedANDA211489
59651-154-3059651-154Dapagliflozin and Metformin hydrochloride Dapagliflozin and Metformin hydrochlorideAurobindo Pharma LimitedANDA211489
67877-619-0567877-619dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochlorideAscend Laboratories, LLCANDA211563
67877-619-3067877-619dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochlorideAscend Laboratories, LLCANDA211563
70748-101-0670748-101DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDA211579
72205-434-0172205-434DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLCANDA211479
72205-434-0272205-434DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLCANDA211479

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA21155933342-406Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideANDAMacleods Pharmaceuticals Limited
ANDA21148959651-154Dapagliflozin and Metformin hydrochloride Dapagliflozin and Metformin hydrochlorideANDAAurobindo Pharma Limited
ANDA21156367877-619dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochlorideANDAAscend Laboratories, LLC
ANDA21157970748-101DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEANDALupin Pharmaceuticals, Inc.
ANDA21147972205-434DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEANDANovadoz Pharmaceuticals LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 13 matching rows.

NDC11, Source, Active table
NDC11SourceActive
33342040606rxnav_ndcsyes
33342040607rxnav_ndcsyes
33342040609rxnav_ndcsyes
33342040610rxnav_ndcsyes
33342040615rxnav_ndcsyes
33342040666rxnav_ndcsyes
59651015405rxnav_ndcsyes
59651015430rxnav_ndcsyes
67877061905rxnav_ndcsyes
67877061930rxnav_ndcsyes
70748010106rxnav_ndcsyes
72205043401rxnav_ndcsyes
72205043402rxnav_ndcsyes

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XIGDUO XRDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAstraZeneca Pharmaceuticals LPac8a0f7b-9f69-4495-abbc-3a47cd75a8592026-08-11Boxed 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
ndc (package): 72205-434-02
ndc (package): 72205-434-01
ndc (product): 72205-434
ndc11 (package): 72205043402
ndc11 (package): 72205043401
rxcui: 1593072
dapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAscend Laboratories, LLCeadcc3ef-f5c2-4a56-a6aa-12909844144e2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 67877-619-30
ndc (package): 67877-619-05
ndc (product): 67877-619
ndc11 (package): 67877061930
ndc11 (package): 67877061905
rxcui: 1593072

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
7d575ca8-9c1f-469d-a341-34daf2f036ddThese 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: 2014Macleods Pharmaceuticals Limited20260916
e6957674-86c1-4536-8e23-54ad7f2cacc4These 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: 2014Lupin Pharmaceuticals, Inc. | LUPIN LIMITED20260908
513bdf9f-774c-4f7f-935a-54d3885e80a4These 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: 2014Aurobindo Pharma Limited | APL HEALTHCARE LIMITED20260902
e6957674-86c1-4536-8e23-54ad7f2cacc4These 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: 2014Lupin Pharmaceuticals, Inc. | LUPIN LIMITED20260421
4f890458-be94-4baf-b606-83a097e1e23eThese 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: 2014Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED20260409
513bdf9f-774c-4f7f-935a-54d3885e80a4These 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: 2014Aurobindo Pharma Limited | APL HEALTHCARE LIMITED20260407
7d575ca8-9c1f-469d-a341-34daf2f036ddThese 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: 2014Macleods Pharmaceuticals Limited20260331
eadcc3ef-f5c2-4a56-a6aa-12909844144eThese 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: 2014Ascend Laboratories, LLC | Alkem Laboratories Limited20260318

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCA10BABiguanidesATC1-4metformin
ATCA10BDCombinations of oral blood glucose lowering drugsATC1-4dapagliflozin / metformin
ATCA10BKSodium-glucose co-transporter 2 (SGLT2) inhibitorsATC1-4dapagliflozin
FDASPLD001645BiguanidesCHEMhas_chemical_structuremetformin
FDASPLN0000175565BiguanideEPChas_epcmetformin
FDASPLN0000187059Sodium-Glucose Cotransporter 2 InhibitorEPChas_epcdapagliflozin
FDASPLN0000187058Sodium-Glucose Transporter 2 InhibitorsMOAhas_moadapagliflozin
MEDRTD001559Benzhydryl CompoundsCHEMhas_ingredientdapagliflozin
MEDRTD005960GlucosidesCHEMhas_ingredientdapagliflozin
MEDRTD008687MetforminCHEMhas_ingredientmetformin
MEDRTD008687MetforminCHEMhas_ingredientmetformin hydrochloride
MEDRTD000138AcidosisDISEASEci_withmetformin hydrochloride
MEDRTD000138AcidosisDISEASEci_withmetformin
MEDRTD003924Diabetes Mellitus, Type 2DISEASEmay_treatmetformin
MEDRTD003924Diabetes Mellitus, Type 2DISEASEmay_treatdapagliflozin
MEDRTD003924Diabetes Mellitus, Type 2DISEASEmay_treatmetformin hydrochloride
MEDRTD016883Diabetic KetoacidosisDISEASEci_withmetformin
MEDRTD016883Diabetic KetoacidosisDISEASEci_withmetformin hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withmetformin hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withmetformin
MEDRTD006333Heart FailureDISEASEmay_treatdapagliflozin
MEDRTD008107Liver DiseasesDISEASEci_withmetformin hydrochloride
MEDRTD008107Liver DiseasesDISEASEci_withmetformin
MEDRTD051437Renal InsufficiencyDISEASEci_withmetformin hydrochloride
MEDRTD051437Renal InsufficiencyDISEASEci_withmetformin
MEDRTN0000000225Insulin Receptor AgonistsMOAhas_moametformin
MEDRTN0000000225Insulin Receptor AgonistsMOAhas_moametformin hydrochloride
MEDRTN0000187058Sodium-Glucose Transporter 2 InhibitorsMOAhas_moadapagliflozin
MEDRTN0000008646Decreased GluconeogenesisPEhas_pemetformin hydrochloride
MEDRTN0000008646Decreased GluconeogenesisPEhas_pemetformin
MEDRTN0000008650Decreased GlycogenesisPEhas_pemetformin
MEDRTN0000008650Decreased GlycogenesisPEhas_pemetformin hydrochloride
MEDRTN0000175650Decreased Sympathetic ActivityPEhas_pedapagliflozin
MEDRTN0000009341Increased Glucose Transport into CellsPEhas_pemetformin hydrochloride
MEDRTN0000009341Increased Glucose Transport into CellsPEhas_pemetformin
MEDRTN0000009556Increased Renal Organic Ion ExcretionPEhas_pedapagliflozin
MEDRTN0000009830Renal Ion Transport AlterationPEhas_pedapagliflozin
MEDRTN0000000042Renal ExcretionPKhas_pkmetformin
MEDRTN0000000042Renal ExcretionPKhas_pkmetformin hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH5 MG / 500 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY24 HR
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA211479
CODESANDAANDA211489
CODESANDAANDA211559
CODESANDAANDA211563
CODESANDAANDA211579
CODESVUID4033846
NAMESPrescribable Synonymdapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet
NAMESTallman Synonym24 HR dapagliflozin 5 MG / metFORMIN hydrochloride 500 MG Extended Release Oral Tablet
NAMESTallman Synonymdapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File