FDA.reportPublic FDA data

24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

RxCUI
1593058
RxNorm name
24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
Display name
Dapagliflozin/metFORMIN XR (Oral Pill)
Full name
24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
Term type
SCD
Status
Active
Strength
10-1,000 mg
Dose form
24 HR XR Tab
Route
Oral Pill
Updated
2026-10-15 14:49:15

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 propanediol10 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_STR24 HR dapagliflozin 10 MG / metFORMIN hydrochloride 1000 MG Extended Release Oral Tablet1NAMES
RxNorm Name24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet1NAMES
RxNorm Synonymdapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
8 linked values
8CODES
RxCUI15930581CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
33342-409-0633342-409Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideMacleods Pharmaceuticals LimitedANDA211559
33342-409-0733342-409Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideMacleods Pharmaceuticals LimitedANDA211559
33342-409-0933342-409Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideMacleods Pharmaceuticals LimitedANDA211559
33342-409-1033342-409Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideMacleods Pharmaceuticals LimitedANDA211559
33342-409-1533342-409Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideMacleods Pharmaceuticals LimitedANDA211559
59651-157-0459651-157Dapagliflozin and Metformin hydrochloride Dapagliflozin and Metformin hydrochlorideAurobindo Pharma LimitedANDA211489
59651-157-3059651-157Dapagliflozin and Metformin hydrochloride Dapagliflozin and Metformin hydrochlorideAurobindo Pharma LimitedANDA211489
63304-028-3063304-028Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideSun Pharmaceutical Industries, Inc.ANDA211491
63304-028-5463304-028Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideSun Pharmaceutical Industries, Inc.ANDA211491
66993-362-3066993-362dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochloridePrasco LaboratoriesNDA205649
67877-622-3067877-622dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochlorideAscend Laboratories, LLCANDA211563
67877-622-3867877-622dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochlorideAscend Laboratories, LLCANDA211563
67877-622-4067877-622dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochlorideAscend Laboratories, LLCANDA211563
67877-622-9067877-622dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochlorideAscend Laboratories, LLCANDA211563
70748-104-0670748-104DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDELupin Pharmaceuticals, Inc.ANDA211579
72205-437-0172205-437DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLCANDA211479
72205-437-0272205-437DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLCANDA211479
72205-437-0372205-437DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLCANDA211479
84677-022-3084677-022Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideGolden State Medical Supply, Inc.ANDA211491

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA21155933342-409Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideANDAMacleods Pharmaceuticals Limited
ANDA21148959651-157Dapagliflozin and Metformin hydrochloride Dapagliflozin and Metformin hydrochlorideANDAAurobindo Pharma Limited
ANDA21149163304-028Dapagliflozin and Metformin Hydrochloride Dapagliflozin and Metformin HydrochlorideANDASun Pharmaceutical Industries, Inc.
NDA20564966993-362dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochlorideNDA AUTHORIZED GENERICPrasco Laboratories
ANDA21156367877-622dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochlorideANDAAscend Laboratories, LLC
ANDA21157970748-104DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEANDALupin Pharmaceuticals, Inc.
ANDA21147972205-437DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEANDANovadoz Pharmaceuticals LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 20 matching rows.

NDC11, Source, Active table
NDC11SourceActive
33342040906rxnav_ndcsyes
33342040907rxnav_ndcsyes
33342040909rxnav_ndcsyes
33342040910rxnav_ndcsyes
33342040915rxnav_ndcsyes
33342040966rxnav_ndcsyes
59651015704rxnav_ndcsyes
59651015730rxnav_ndcsyes
63304002830rxnav_ndcsyes
63304002854rxnav_ndcsyes
66993036230rxnav_ndcsyes
67877062230rxnav_ndcsyes
67877062238rxnav_ndcsyes
67877062240rxnav_ndcsyes
67877062290rxnav_ndcsyes
70748010406rxnav_ndcsyes
72205043701rxnav_ndcsyes
72205043702rxnav_ndcsyes
72205043703rxnav_ndcsyes
84677002230rxnav_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 · 4 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: 1593058
Dapagliflozin and Metformin HydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.54027b70-53e7-3710-e063-6394a90aa04c2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 84677-022-30
ndc (product): 84677-022
ndc11 (package): 84677002230
rxcui: 1593058
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLC4f890458-be94-4baf-b606-83a097e1e23e2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 72205-437-02
ndc (package): 72205-437-01
ndc (package): 72205-437-03
ndc (product): 72205-437
ndc11 (package): 72205043701
ndc11 (package): 72205043702
ndc11 (package): 72205043703
rxcui: 1593058
dapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAscend Laboratories, LLCeadcc3ef-f5c2-4a56-a6aa-12909844144e2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 67877-622-30
ndc (package): 67877-622-40
ndc (package): 67877-622-38
ndc (package): 67877-622-90
ndc (product): 67877-622
ndc11 (package): 67877062230
ndc11 (package): 67877062240
ndc11 (package): 67877062238
ndc11 (package): 67877062290
rxcui: 1593058

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 · 8 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ac8a0f7b-9f69-4495-abbc-3a47cd75a859dapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR 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 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR 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 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR 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
eaf135b6-e378-4f62-a1e7-db45e23668c7dapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet [SY]37These 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: 201420241220
bddc2d47-8d3d-4c2f-8e5c-7a1a0782219adapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet [SY]32These 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
4f890458-be94-4baf-b606-83a097e1e23edapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR 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 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR 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 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [SCD] · dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR 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
bddc2d47-8d3d-4c2f-8e5c-7a1a0782219aThese 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: 2014Sun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc.20260917
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
eaf135b6-e378-4f62-a1e7-db45e23668c7These 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: 2014Prasco Laboratories | AstraZeneca PLC | AstraZeneca Pharmaceuticals LP20260801
54027b70-53e7-3710-e063-6394a90aa04cDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS. 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: 2014Golden State Medical Supply, Inc.20260611
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
bddc2d47-8d3d-4c2f-8e5c-7a1a0782219aThese 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: 2014Sun Pharmaceutical Industries, Inc.20260331
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
eaf135b6-e378-4f62-a1e7-db45e23668c7These 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: 2014Prasco Laboratories | 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_STRENGTH10 MG / 1000 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY24 HR
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA211479
CODESANDAANDA211489
CODESANDAANDA211491
CODESANDAANDA211559
CODESANDAANDA211563
CODESANDAANDA211579
CODESVUID4033849
NAMESPrescribable Synonymdapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
NAMESTallman Synonym24 HR dapagliflozin 10 MG / metFORMIN hydrochloride 1000 MG Extended Release Oral Tablet
NAMESTallman Synonymdapagliflozin (as dapagliflozin propanediol) 10 MG / metFORMIN hydrochloride 1000 MG 24 HR 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