FDA.reportPublic FDA data

FARXIGA

Product NDC
0310-6205
11-digit product format
003106205
Labeler code
0310
Product ID
0310-6205_10d25358-e717-4294-9ec1-c73b8f45009d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPAGLIFLOZIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA202293
Marketing category
NDA
Marketing start
2008-01-14
Substance
DAPAGLIFLOZIN PROPANEDIOL
Active strength
5 mg/1
Pharmacologic classes
Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FARXIGA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN PROPANEDIOL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii887K2391VH

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c30aab5e-c89f-4b59-83b1-99a940b63351Product name120200925
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
85b4e38c-4488-4e48-919e-244e107d9bd9Product name220190731
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-6205-30FARXIGA30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3045
0310-6205-90FARXIGA90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9045
0310-6205-95FARXIGA1 in 1 CARTONTABLET, FILM COATED145
0310-6205-95FARXIGA7 in 1 BLISTER PACKTABLET, FILM COATED745

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-6205-30EA - Each0310-62057e7b71cc-c339-4427-8638-1fa97b1bb75c12015-03-03
0310-6205-90EA - Each0310-62051bf111c2-0143-4476-8e88-46a5d9ae2ded12024-05-16
0310-6205-95EA - Each0310-620536a2582f-3f30-47b6-b46d-9591924825e012021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DAPAGLIFLOZIN PROPANEDIOLACTIVE INGREDIENT887K2391VHFARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]3
dapagliflozinACTIVE MOIETY1ULL0QJ8UCFARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]3
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKFARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UFARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]3
crospovidoneINACTIVE INGREDIENT68401960MKFARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]3
magnesium stearateINACTIVE INGREDIENT70097M6I30FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]3
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-6205FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]43Current NDC, Legacy NDC, 4 package rows20241031_72ad22ae-efe6-4cd6-a302-98aaee423d69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSN72ad22ae-efe6-4cd6-a302-98aaee423d6945
1488574dapagliflozin 5 MG Oral TabletPSN72ad22ae-efe6-4cd6-a302-98aaee423d6945
1486977farxiga 10 MG Oral TabletPSN72ad22ae-efe6-4cd6-a302-98aaee423d6945
1486981farxiga 5 MG Oral TabletPSN72ad22ae-efe6-4cd6-a302-98aaee423d6945
1486977dapagliflozin 10 MG Oral Tablet [Farxiga]SBD72ad22ae-efe6-4cd6-a302-98aaee423d6945
1486981dapagliflozin 5 MG Oral Tablet [Farxiga]SBD72ad22ae-efe6-4cd6-a302-98aaee423d6945
1488569dapagliflozin 10 MG Oral TabletSCD72ad22ae-efe6-4cd6-a302-98aaee423d6945
1488574dapagliflozin 5 MG Oral TabletSCD72ad22ae-efe6-4cd6-a302-98aaee423d6945
1488569dapagliflozin 10 MG Oral TabletSY72ad22ae-efe6-4cd6-a302-98aaee423d6945
1488574dapagliflozin 5 MG Oral TabletSY72ad22ae-efe6-4cd6-a302-98aaee423d6945
1486977Farxiga 10 MG Oral TabletSY72ad22ae-efe6-4cd6-a302-98aaee423d6945
1486981Farxiga 5 MG Oral TabletSY72ad22ae-efe6-4cd6-a302-98aaee423d6945
1488569dapagliflozin 10 MG Oral TabletPSN40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc20
1488574dapagliflozin 5 MG Oral TabletPSN40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc20
1486977farxiga 10 MG Oral TabletPSN40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc20
1486981farxiga 5 MG Oral TabletPSN40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc20
1486977dapagliflozin 10 MG Oral Tablet [Farxiga]SBD40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc20
1486981dapagliflozin 5 MG Oral Tablet [Farxiga]SBD40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc20
1488569dapagliflozin 10 MG Oral TabletSCD40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc20
1488574dapagliflozin 5 MG Oral TabletSCD40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc20
1488569dapagliflozin 10 MG Oral TabletSY40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc20
1488574dapagliflozin 5 MG Oral TabletSY40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc20
1486977Farxiga 10 MG Oral TabletSY40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc20
1486981Farxiga 5 MG Oral TabletSY40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc20
1488569dapagliflozin 10 MG Oral TabletPSN01f90c94-71cb-4a1f-81ff-8004b850529b15
1488574dapagliflozin 5 MG Oral TabletPSN01f90c94-71cb-4a1f-81ff-8004b850529b15
1486977farxiga 10 MG Oral TabletPSN01f90c94-71cb-4a1f-81ff-8004b850529b15
1486981farxiga 5 MG Oral TabletPSN01f90c94-71cb-4a1f-81ff-8004b850529b15
1486977dapagliflozin 10 MG Oral Tablet [Farxiga]SBD01f90c94-71cb-4a1f-81ff-8004b850529b15
1486981dapagliflozin 5 MG Oral Tablet [Farxiga]SBD01f90c94-71cb-4a1f-81ff-8004b850529b15
1488569dapagliflozin 10 MG Oral TabletSCD01f90c94-71cb-4a1f-81ff-8004b850529b15
1488574dapagliflozin 5 MG Oral TabletSCD01f90c94-71cb-4a1f-81ff-8004b850529b15
1488569dapagliflozin 10 MG Oral TabletSY01f90c94-71cb-4a1f-81ff-8004b850529b15
1488574dapagliflozin 5 MG Oral TabletSY01f90c94-71cb-4a1f-81ff-8004b850529b15
1486977Farxiga 10 MG Oral TabletSY01f90c94-71cb-4a1f-81ff-8004b850529b15
1486981Farxiga 5 MG Oral TabletSY01f90c94-71cb-4a1f-81ff-8004b850529b15
1488574dapagliflozin 5 MG Oral TabletPSNef9e9c8c-5460-4193-952a-0c249dd071bd1
1486981farxiga 5 MG Oral TabletPSNef9e9c8c-5460-4193-952a-0c249dd071bd1
1486981dapagliflozin 5 MG Oral Tablet [Farxiga]SBDef9e9c8c-5460-4193-952a-0c249dd071bd1
1488574dapagliflozin 5 MG Oral TabletSCDef9e9c8c-5460-4193-952a-0c249dd071bd1
1488574dapagliflozin 5 MG Oral TabletSYef9e9c8c-5460-4193-952a-0c249dd071bd1
1486981Farxiga 5 MG Oral TabletSYef9e9c8c-5460-4193-952a-0c249dd071bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-6205-300031062053030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30) 2015-02-020000-00-00NoNoCurrent
0310-6205-900031062059090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-90) 2024-03-18NoNoHistorical
0310-6205-95003106205951 BLISTER PACK in 1 CARTON (0310-6205-95) / 7 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2015-02-020000-00-00YesNoCurrent