FDA.reportPublic FDA data

Dapagliflozin

Product NDC
73190-073
Requested package NDC
73190-073-90
11-digit product format
731900073
Labeler code
73190
Product ID
73190-073_52a7bfac-a5ec-cba1-e063-6394a90a35ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapagliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA211478
Marketing category
ANDA
Marketing start
2026-05-25
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
A211478-001DAPAGLIFLOZINDAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06
A211478-002DAPAGLIFLOZINDAPAGLIFLOZIN10MGTABLET / 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
A211478-001AB
A211478-002AB

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 06:07:402026-07A211478-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211478-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211478-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211478-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211478-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211478-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211478-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211478-002AB1a50c72e98297…

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
52a778e7-6044-2049-e063-6294a90aa0b7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
c30aab5e-c89f-4b59-83b1-99a940b63351Product name120200925
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
85b4e38c-4488-4e48-919e-244e107d9bd9Product name220190731
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73190-073-30Dapagliflozin30 in 1 BOTTLETABLET, FILM COATED302
73190-073-90Dapagliflozin90 in 1 BOTTLETABLET, FILM COATED902

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
DapagliflozinDAPAGLIFLOZINNovadoz Pharmaceuticals LLC107b4d25-4764-42b7-80e3-9aaff20865ed2026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211478
application number: ANDA211478
DapagliflozinDAPAGLIFLOZINAvKARE52a778e7-6044-2049-e063-6294a90aa0b72026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211478
application number: ANDA211478
ndc (package): 73190-073-90
ndc (product): 73190-073
ndc11 (package): 73190007390

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSN52a778e7-6044-2049-e063-6294a90aa0b72
1488574dapagliflozin 5 MG Oral TabletPSN52a778e7-6044-2049-e063-6294a90aa0b72
1488569dapagliflozin 10 MG Oral TabletSCD52a778e7-6044-2049-e063-6294a90aa0b72
1488574dapagliflozin 5 MG Oral TabletSCD52a778e7-6044-2049-e063-6294a90aa0b72
1488569dapagliflozin 10 MG Oral TabletSY52a778e7-6044-2049-e063-6294a90aa0b72
1488574dapagliflozin 5 MG Oral TabletSY52a778e7-6044-2049-e063-6294a90aa0b72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73190-073-907319000739090 TABLET, FILM COATED in 1 BOTTLE (73190-073-90) 2026-05-25NoNoCurrent