FDA.reportPublic FDA data

dapagliflozin 10 MG Oral Tablet [Farxiga]

RxCUI
1486977
RxNorm name
dapagliflozin 10 MG Oral Tablet [Farxiga]
Display name
FARXIGA (Oral Pill)
Full name
dapagliflozin 10 MG Oral Tablet [Farxiga]
Term type
SBD
Status
Active
Strength
10 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-08-18 06:17:57

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
022014
Active start
022014
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dapagliflozin10 MG / 1 EACHdapagliflozindapagliflozin

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
dapagliflozin1488564

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRFarxiga 10 MG Oral Tablet1NAMES
RxNorm Namedapagliflozin 10 MG Oral Tablet [Farxiga]1NAMES
RxNorm SynonymFarxiga 10 MG Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI14869771CODES
MMSL_CODEBD280231CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0310-6210-300310-6210FARXIGA DAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDA202293
0310-6210-390310-6210FARXIGA DAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDA202293
0310-6210-900310-6210FARXIGA DAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDA202293
0310-6210-950310-6210FARXIGA DAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDA202293
50090-3481-050090-3481FARXIGA DAPAGLIFLOZINA-S Medication SolutionsNDA202293
55154-6933-855154-6933FARXIGA DAPAGLIFLOZINCardinal Health 107, LLCNDA202293

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA2022930310-6210FARXIGA DAPAGLIFLOZINNDAAstraZeneca Pharmaceuticals LP

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 11 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00310621030rxnav_ndcsyes
00310621039rxnav_ndcsyes
00310621090rxnav_ndcsyes
00310621095rxnav_ndcsyes
50090348100rxnav_ndcsyes
55154693308rxnav_ndcsyes
00003142811rxnav_historical
00003142812rxnav_historical
00003142813rxnav_historical
00003142814rxnav_historical
00003142891rxnav_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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FARXIGADAPAGLIFLOZINA-S Medication Solutions01f90c94-71cb-4a1f-81ff-8004b850529b2026-07-10Warnings, Adverse reactionsExact identifier
ndc (package): 50090-3481-0
ndc (product): 50090-3481
ndc11 (package): 50090348100
rxcui: 1486977
FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LP72ad22ae-efe6-4cd6-a302-98aaee423d692026-06-03Warnings, Adverse reactionsExact identifier
ndc (package): 0310-6210-30
ndc (package): 0310-6210-39
ndc (package): 0310-6210-95
ndc (package): 0310-6210-90
ndc (product): 0310-6210
ndc11 (package): 00310621039
ndc11 (package): 00310621095
ndc11 (package): 00310621030
ndc11 (package): 00310621090
rxcui: 1486977

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
72ad22ae-efe6-4cd6-a302-98aaee423d69farxiga 10 MG Oral Tablet [PSN] · dapagliflozin 10 MG Oral Tablet [Farxiga] [SBD] · Farxiga 10 MG Oral Tablet [SY]345These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 201420241024
40cc4f5d-bcf6-4016-9d1e-838bbc4bdddcfarxiga 10 MG Oral Tablet [PSN] · dapagliflozin 10 MG Oral Tablet [Farxiga] [SBD] · Farxiga 10 MG Oral Tablet [SY]320These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 201420240829
01f90c94-71cb-4a1f-81ff-8004b850529bfarxiga 10 MG Oral Tablet [PSN] · dapagliflozin 10 MG Oral Tablet [Farxiga] [SBD] · Farxiga 10 MG Oral Tablet [SY]315These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 201420231212

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
01f90c94-71cb-4a1f-81ff-8004b850529bThese highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014A-S Medication Solutions20260710
72ad22ae-efe6-4cd6-a302-98aaee423d69These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014AstraZeneca Pharmaceuticals LP20260603
72ad22ae-efe6-4cd6-a302-98aaee423d69These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014AstraZeneca Pharmaceuticals LP20251222
72ad22ae-efe6-4cd6-a302-98aaee423d69These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014AstraZeneca Pharmaceuticals LP20241024
40cc4f5d-bcf6-4016-9d1e-838bbc4bdddcThese highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014Cardinal Health 107, LLC20240829
01f90c94-71cb-4a1f-81ff-8004b850529bThese highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014A-S Medication Solutions20231212

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCA10BKSodium-glucose co-transporter 2 (SGLT2) inhibitorsATC1-4dapagliflozin
FDASPLN0000187059Sodium-Glucose Cotransporter 2 InhibitorEPChas_epcdapagliflozin
FDASPLN0000187058Sodium-Glucose Transporter 2 InhibitorsMOAhas_moadapagliflozin
MEDRTD001559Benzhydryl CompoundsCHEMhas_ingredientdapagliflozin
MEDRTD005960GlucosidesCHEMhas_ingredientdapagliflozin
MEDRTD003924Diabetes Mellitus, Type 2DISEASEmay_treatdapagliflozin
MEDRTD006333Heart FailureDISEASEmay_treatdapagliflozin
MEDRTN0000187058Sodium-Glucose Transporter 2 InhibitorsMOAhas_moadapagliflozin
MEDRTN0000175650Decreased Sympathetic ActivityPEhas_pedapagliflozin
MEDRTN0000009556Increased Renal Organic Ion ExcretionPEhas_pedapagliflozin
MEDRTN0000009830Renal Ion Transport AlterationPEhas_pedapagliflozin

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH10 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA202293
NAMESPrescribable Synonymfarxiga 10 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon