FDA.reportPublic FDA data

Dapagliflozin

Product NDC
0781-5985
11-digit product format
007815985
Labeler code
0781
Product ID
0781-5985_8296f538-4c23-4d6c-be53-8005b83c24b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapagliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA211312
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
A211312-001DAPAGLIFLOZINDAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06
A211312-002DAPAGLIFLOZINDAPAGLIFLOZIN10MGTABLET / 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
A211312-001AB
A211312-002AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A211312-001PC2026-10-03
A211312-002PC2026-10-03

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 22:54:322026-06A211312-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06a50c72e98297…
2026-08-01 22:54:322026-06A211312-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211312-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A211312-002AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06A211312-001PC2026-10-03a50c72e98297…
2026-08-01 22:54:322026-06A211312-002PC2026-10-03a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DapagliflozinDAPAGLIFLOZINSandoz Inc8296f538-4c23-4d6c-be53-8005b83c24b72026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211312
application number: ANDA211312
ndc (product): 0781-5985

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 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
8296f538-4c23-4d6c-be53-8005b83c24b7Available 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
0781-5985-01Dapagliflozin100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
0781-5985-05Dapagliflozin500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5001
0781-5985-10Dapagliflozin1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10001
0781-5985-31Dapagliflozin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5985-31EA - Each0781-598568b204a9-432a-4997-97ce-dcaf9215fd6012026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSN8296f538-4c23-4d6c-be53-8005b83c24b71
1488574dapagliflozin 5 MG Oral TabletPSN8296f538-4c23-4d6c-be53-8005b83c24b71
1488569dapagliflozin 10 MG Oral TabletSCD8296f538-4c23-4d6c-be53-8005b83c24b71
1488574dapagliflozin 5 MG Oral TabletSCD8296f538-4c23-4d6c-be53-8005b83c24b71
1488569dapagliflozin 10 MG Oral TabletSY8296f538-4c23-4d6c-be53-8005b83c24b71
1488574dapagliflozin 5 MG Oral TabletSY8296f538-4c23-4d6c-be53-8005b83c24b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0781-5985-0100781598501100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-5985-01) 2026-04-06NoNoCurrent
0781-5985-0500781598505500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-5985-05) 2026-04-06NoNoCurrent
0781-5985-10007815985101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-5985-10) 2026-04-06NoNoCurrent
0781-5985-310078159853130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-5985-31) 2026-04-06NoNoCurrent