FDA.reportPublic FDA data

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

RxCUI
1593833
RxNorm name
24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Xigduo]
Display name
XIGDUO XR (Oral Pill)
Full name
24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Xigduo]
Term type
SBD
Status
Active
Strength
5-1,000 mg
Dose form
24 HR XR Tab
Route
Oral Pill
Updated
2026-10-15 14:50:26

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122014
Active start
122014
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dapagliflozin propanediol5 MG / 1 EACHdapagliflozindapagliflozin
metformin hydrochloride1000 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#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRXigduo XR 5/1000 24HR Extended Release Oral Tablet1NAMES
RxNorm Name24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Xigduo]1NAMES
RxNorm SynonymXigduo XR 5/1000 24HR Extended Release Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDac8a0f7b-9f69-4495-abbc-3a47cd75a8591CODES
RxCUI15938331CODES
MMSL_CODEBD299681CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0310-6260-600310-6260XIGDUO dapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDA205649
0310-6260-950310-6260XIGDUO dapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDA205649

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA2056490310-6260XIGDUO dapagliflozin and metformin hydrochlorideNDAAstraZeneca Pharmaceuticals LP

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00310626060rxnav_ndcsyes
00310626095rxnav_ndcsyes
00310626030rxnav_historical
00310626094rxnav_historical

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 · 1 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
ndc (package): 0310-6260-95
ndc (package): 0310-6260-60
ndc (product): 0310-6260
ndc11 (package): 00310626094
ndc11 (package): 00310626060
ndc11 (package): 00310626095
ndc11 (package): 00310626030
rxcui: 1593833

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ac8a0f7b-9f69-4495-abbc-3a47cd75a859Xigduo XR 5/1000 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Xigduo] [SBD] · Xigduo XR 5/1000 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

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
ac8a0f7b-9f69-4495-abbc-3a47cd75a859These 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: 2014AstraZeneca Pharmaceuticals LP20260811
ac8a0f7b-9f69-4495-abbc-3a47cd75a859These 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: 2014AstraZeneca Pharmaceuticals LP20260811
ac8a0f7b-9f69-4495-abbc-3a47cd75a859These 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: 2014AstraZeneca Pharmaceuticals LP | AstraZeneca PLC20241220

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 / 1000 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY24 HR
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA205649
NAMESPrescribable SynonymXigduo XR 5/1000 24HR Extended Release Oral Tablet
NAMESTallman Synonym24 HR dapagliflozin 5 MG / metFORMIN hydrochloride 1000 MG Extended Release Oral Tablet [Xigduo]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon