FDA.reportPublic FDA data

Dapagliflozin

Product NDC
59651-159
11-digit product format
596510159
Labeler code
59651
Product ID
59651-159_7305d6e0-2260-4545-8c21-712f5d96675b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapagliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA211468
Marketing category
ANDA
Marketing start
2026-04-06
Substance
DAPAGLIFLOZIN
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
A211468-001DAPAGLIFLOZINDAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06
A211468-002DAPAGLIFLOZINDAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211468-001AB
A211468-002AB

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 22:54:322026-06A211468-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06a50c72e98297…
2026-08-01 22:54:322026-06A211468-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211468-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A211468-002AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DapagliflozinDAPAGLIFLOZINAurobindo Pharma Limitedf56593f7-588e-489d-9fad-b459e90dab182026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211468
application number: ANDA211468
ndc (product): 59651-159
DapagliflozinDAPAGLIFLOZINA-S Medication Solutionsaddc6ead-f9e3-4b40-aed1-bc008a5c9b0f2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211468
application number: ANDA211468
DapagliflozinDAPAGLIFLOZINA-S Medication Solutionsc4264ff6-5199-49e9-91d3-3ad67b42f88d2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211468
application number: ANDA211468

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ULL0QJ8UCInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f56593f7-588e-489d-9fad-b459e90dab18Available 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
59651-159-30Dapagliflozin30 in 1 BOTTLETABLET, FILM COATED302
59651-159-90Dapagliflozin90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-159-30EA - Each59651-159e6a43bf4-493f-402b-a57d-b490d3e975f912026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSNf56593f7-588e-489d-9fad-b459e90dab182
1488574dapagliflozin 5 MG Oral TabletPSNf56593f7-588e-489d-9fad-b459e90dab182
1488569dapagliflozin 10 MG Oral TabletSCDf56593f7-588e-489d-9fad-b459e90dab182
1488574dapagliflozin 5 MG Oral TabletSCDf56593f7-588e-489d-9fad-b459e90dab182
1488569dapagliflozin 10 MG Oral TabletSYf56593f7-588e-489d-9fad-b459e90dab182
1488574dapagliflozin 5 MG Oral TabletSYf56593f7-588e-489d-9fad-b459e90dab182
1488574dapagliflozin 5 MG Oral TabletPSNc4264ff6-5199-49e9-91d3-3ad67b42f88d1
1488574dapagliflozin 5 MG Oral TabletSCDc4264ff6-5199-49e9-91d3-3ad67b42f88d1
1488574dapagliflozin 5 MG Oral TabletSYc4264ff6-5199-49e9-91d3-3ad67b42f88d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-159-305965101593030 TABLET, FILM COATED in 1 BOTTLE (59651-159-30) 2026-04-06NoNoCurrent
59651-159-905965101599090 TABLET, FILM COATED in 1 BOTTLE (59651-159-90) 2026-05-08NoNoCurrent