FDA.reportPublic FDA data

Dapagliflozin

Product NDC
50090-7972
Requested package NDC
50090-7972-0
11-digit product format
500907972
Labeler code
50090
Product ID
50090-7972_107fd3b4-6961-493e-a855-0e305ee2e9cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapagliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211468
Marketing category
ANDA
Marketing start
2026-04-06
Substance
DAPAGLIFLOZIN
Active strength
10 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 42.

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
2026-08-18 06:07:402026-07A211468-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211468-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211468-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211468-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211468-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211468-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211468-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211468-002AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN10 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
addc6ead-f9e3-4b40-aed1-bc008a5c9b0fAvailable 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
50090-7972-0Dapagliflozin30 in 1 BOTTLETABLET, FILM COATED301

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 · 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
DapagliflozinDAPAGLIFLOZINA-S Medication Solutionsaddc6ead-f9e3-4b40-aed1-bc008a5c9b0f2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211468
application number: ANDA211468
ndc (package): 50090-7972-0
ndc (product): 50090-7972
ndc11 (package): 50090797200
DapagliflozinDAPAGLIFLOZINA-S Medication Solutionsc4264ff6-5199-49e9-91d3-3ad67b42f88d2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211468
application number: ANDA211468

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSNaddc6ead-f9e3-4b40-aed1-bc008a5c9b0f1
1488569dapagliflozin 10 MG Oral TabletSCDaddc6ead-f9e3-4b40-aed1-bc008a5c9b0f1
1488569dapagliflozin 10 MG Oral TabletSYaddc6ead-f9e3-4b40-aed1-bc008a5c9b0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7972-05009079720030 TABLET, FILM COATED in 1 BOTTLE (50090-7972-0) 2026-05-14NoNoCurrent