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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202293-001FARXIGADAPAGLIFLOZIN5MGTABLET / ORALABRLD2014-01-08
N202293-002FARXIGADAPAGLIFLOZIN10MGTABLET / ORALABRLD, RS2014-01-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N202293-001AB
N202293-002AB

Orange Book patents#

Current patent rows page 1 of 1 · 64 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N202293-00165151172025-10-04U-2139Drug substance, Drug product2014-02-05
N202293-00165151172025-10-04U-493Drug substance, Drug product2014-02-05
N202293-0016515117*PED2026-04-04Pediatric extension
N202293-00183296482026-08-18U-21392017-11-15
N202293-00183296482026-08-18U-22122017-11-15
N202293-00183296482026-08-18U-22132017-11-15
N202293-00189068512026-08-18U-21392017-11-15
N202293-0018329648*PED2027-02-18Pediatric extension
N202293-0018906851*PED2027-02-18Pediatric extension
N202293-00185016982027-06-20U-493Drug product2014-02-05
N202293-0018501698*PED2027-12-20Pediatric extension
N202293-00182217862028-03-21Drug product2014-02-05
N202293-00183619722028-03-21U-21392014-02-05
N202293-00183619722028-03-21U-4932014-02-05
N202293-00187162512028-03-21Drug product2014-06-02
N202293-00178515022028-08-19Drug product2014-02-05
N202293-0018221786*PED2028-09-21Pediatric extension
N202293-0018361972*PED2028-09-21Pediatric extension
N202293-0018716251*PED2028-09-21Pediatric extension
N202293-0017851502*PED2029-02-19Pediatric extension
N202293-00179195982029-12-16Drug substance2014-02-05
N202293-00187216152030-01-18Drug product, Delist requested2017-11-15
N202293-00186859342030-05-26U-15222014-06-25
N202293-0017919598*PED2030-06-16Pediatric extension
N202293-0018721615*PED2030-07-18Pediatric extension
N202293-0018685934*PED2030-11-26Pediatric extension
N202293-00265151172025-10-04U-2139Drug substance, Drug product2014-02-05
N202293-00265151172025-10-04U-493Drug substance, Drug product2014-02-05
N202293-0026515117*PED2026-04-04Pediatric extension
N202293-00283296482026-08-18U-21392017-11-15
N202293-00283296482026-08-18U-22122017-11-15
N202293-00283296482026-08-18U-22132017-11-15
N202293-00289068512026-08-18U-21392017-11-15
N202293-0028329648*PED2027-02-18Pediatric extension
N202293-0028906851*PED2027-02-18Pediatric extension
N202293-00285016982027-06-20U-493Drug product2014-02-05
N202293-0028501698*PED2027-12-20Pediatric extension
N202293-00282217862028-03-21Drug product2014-02-05
N202293-00283619722028-03-21U-21392014-02-05
N202293-00283619722028-03-21U-4932014-02-05
N202293-00287162512028-03-21Drug product2014-06-02
N202293-00278515022028-08-19Drug product2014-02-05
N202293-0028221786*PED2028-09-21Pediatric extension
N202293-0028361972*PED2028-09-21Pediatric extension
N202293-0028716251*PED2028-09-21Pediatric extension
N202293-0027851502*PED2029-02-19Pediatric extension
N202293-00279195982029-12-16Drug substance2014-02-05
N202293-00287216152030-01-18Drug product, Delist requested2017-11-15
N202293-00286859342030-05-26U-15222014-06-25
N202293-0027919598*PED2030-06-16Pediatric extension
N202293-0028721615*PED2030-07-18Pediatric extension
N202293-0028685934*PED2030-11-26Pediatric extension
N202293-002118263762039-07-18U-37662023-12-19
N202293-002124721942039-07-18U-43462025-12-11
N202293-00211826376*PED2040-01-18Pediatric extension
N202293-00212472194*PED2040-01-18Pediatric extension
N202293-002109738362040-03-09U-31272021-04-21
N202293-002119039552040-03-09U-38252024-03-13
N202293-00210973836*PED2040-09-09Pediatric extension
N202293-00211903955*PED2040-09-09Pediatric extension
N202293-002122139882041-04-01U-41402025-03-04
N202293-002124091862041-04-01U-41402025-09-29
N202293-00212213988*PED2041-10-01Pediatric extension
N202293-00212409186*PED2041-10-01Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N202293-001M-2982026-05-08
N202293-001PED2026-11-08
N202293-001NPP2027-06-12
N202293-001PED2027-12-12
N202293-002M-2982026-05-08
N202293-002PED2026-11-08
N202293-002NPP2027-06-12
N202293-002PED2027-12-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N202293-001FARXIGA5MGTABLET / ORALABRLD2014-01-08a50c72e98297…
2026-08-01 22:54:322026-06N202293-002FARXIGA10MGTABLET / ORALABRLD, RS2014-01-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N202293-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N202293-002AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N202293-00165151172025-10-04U-493Drug substance, Drug product2014-02-05a50c72e98297…
2026-08-01 22:54:322026-06N202293-00165151172025-10-04U-2139Drug substance, Drug product2014-02-05a50c72e98297…
2026-08-01 22:54:322026-06N202293-0016515117*PED2026-04-04Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-00183296482026-08-18U-22132017-11-15a50c72e98297…
2026-08-01 22:54:322026-06N202293-00183296482026-08-18U-21392017-11-15a50c72e98297…
2026-08-01 22:54:322026-06N202293-00183296482026-08-18U-22122017-11-15a50c72e98297…
2026-08-01 22:54:322026-06N202293-00189068512026-08-18U-21392017-11-15a50c72e98297…
2026-08-01 22:54:322026-06N202293-0018329648*PED2027-02-18Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-0018906851*PED2027-02-18Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-00185016982027-06-20U-493Drug product2014-02-05a50c72e98297…
2026-08-01 22:54:322026-06N202293-0018501698*PED2027-12-20Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-00182217862028-03-21Drug product2014-02-05a50c72e98297…
2026-08-01 22:54:322026-06N202293-00183619722028-03-21U-21392014-02-05a50c72e98297…
2026-08-01 22:54:322026-06N202293-00183619722028-03-21U-4932014-02-05a50c72e98297…
2026-08-01 22:54:322026-06N202293-00187162512028-03-21Drug product2014-06-02a50c72e98297…
2026-08-01 22:54:322026-06N202293-00178515022028-08-19Drug product2014-02-05a50c72e98297…
2026-08-01 22:54:322026-06N202293-0018221786*PED2028-09-21Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-0018361972*PED2028-09-21Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-0018716251*PED2028-09-21Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-0017851502*PED2029-02-19Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-00179195982029-12-16Drug substance2014-02-05a50c72e98297…
2026-08-01 22:54:322026-06N202293-00187216152030-01-18Drug product, Delist requested2017-11-15a50c72e98297…
2026-08-01 22:54:322026-06N202293-00186859342030-05-26U-15222014-06-25a50c72e98297…
2026-08-01 22:54:322026-06N202293-0017919598*PED2030-06-16Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-0018721615*PED2030-07-18Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-0018685934*PED2030-11-26Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-00265151172025-10-04U-2139Drug substance, Drug product2014-02-05a50c72e98297…
2026-08-01 22:54:322026-06N202293-00265151172025-10-04U-493Drug substance, Drug product2014-02-05a50c72e98297…
2026-08-01 22:54:322026-06N202293-0026515117*PED2026-04-04Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-00283296482026-08-18U-21392017-11-15a50c72e98297…
2026-08-01 22:54:322026-06N202293-00283296482026-08-18U-22122017-11-15a50c72e98297…
2026-08-01 22:54:322026-06N202293-00283296482026-08-18U-22132017-11-15a50c72e98297…
2026-08-01 22:54:322026-06N202293-00289068512026-08-18U-21392017-11-15a50c72e98297…
2026-08-01 22:54:322026-06N202293-0028329648*PED2027-02-18Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-0028906851*PED2027-02-18Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-00285016982027-06-20U-493Drug product2014-02-05a50c72e98297…
2026-08-01 22:54:322026-06N202293-0028501698*PED2027-12-20Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202293-00282217862028-03-21Drug product2014-02-05a50c72e98297…
2026-08-01 22:54:322026-06N202293-00283619722028-03-21U-21392014-02-05a50c72e98297…
2026-08-01 22:54:322026-06N202293-00283619722028-03-21U-4932014-02-05a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N202293-001M-2982026-05-08a50c72e98297…
2026-08-01 22:54:322026-06N202293-001PED2026-11-08a50c72e98297…
2026-08-01 22:54:322026-06N202293-001NPP2027-06-12a50c72e98297…
2026-08-01 22:54:322026-06N202293-001PED2027-12-12a50c72e98297…
2026-08-01 22:54:322026-06N202293-002M-2982026-05-08a50c72e98297…
2026-08-01 22:54:322026-06N202293-002PED2026-11-08a50c72e98297…
2026-08-01 22:54:322026-06N202293-002NPP2027-06-12a50c72e98297…
2026-08-01 22:54:322026-06N202293-002PED2027-12-12a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 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
application applno (NDA): 202293
application number: NDA202293
FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LP72ad22ae-efe6-4cd6-a302-98aaee423d692026-06-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 202293
application number: NDA202293
ndc (product): 0310-6205
DAPAGLIFLOZINDAPAGLIFLOZINPrasco Laboratories3aba33aa-f8c6-4b10-85c8-dfa14578d07c2026-06-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 202293
application number: NDA202293
FARXIGADAPAGLIFLOZINREMEDYREPACK INC.ef9e9c8c-5460-4193-952a-0c249dd071bd2026-04-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 202293
application number: NDA202293
DAPAGLIFLOZINDAPAGLIFLOZINBryant Ranch Prepack979205ee-b0b8-4483-ae61-f283f750bb7f2024-08-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 202293
application number: NDA202293
DAPAGLIFLOZINDAPAGLIFLOZINA-S Medication Solutions82cdd5ad-df2b-4bdd-a3a6-a059040100b42024-06-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 202293
application number: NDA202293
DAPAGLIFLOZINDAPAGLIFLOZINA-S Medication Solutions87521963-0d2a-4a2a-89c6-d50e8582419e2024-06-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 202293
application number: NDA202293

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
887K2391VHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1486977Internal RxNorm lookup
1486981Internal RxNorm lookup
1488569Internal RxNorm lookup
1488574Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
72ad22ae-efe6-4cd6-a302-98aaee423d69Available on FDA.report

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#

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) 2024-03-18NoNoCurrent
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