FDA.reportPublic FDA data

Dapagliflozin

Product NDC
67877-609
11-digit product format
678770609
Labeler code
67877
Product ID
67877-609_50d5c427-8611-4490-8b2e-ee40ea7f9707
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapagliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA211545
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 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
A211545-001DAPAGLIFLOZINDAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06
A211545-002DAPAGLIFLOZINDAPAGLIFLOZIN10MGTABLET / 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
A211545-001AB
A211545-002AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A211545-001PC2026-10-03
A211545-002PC2026-10-03

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 22:54:322026-06A211545-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06a50c72e98297…
2026-08-01 22:54:322026-06A211545-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211545-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A211545-002AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06A211545-001PC2026-10-03a50c72e98297…
2026-08-01 22:54:322026-06A211545-002PC2026-10-03a50c72e98297…

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
DapagliflozinDAPAGLIFLOZINAscend Laboratories, LLCb6b8a10c-64c3-4856-8961-d72d68784f5d2026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211545
application number: ANDA211545
ndc (product): 67877-609

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
b6b8a10c-64c3-4856-8961-d72d68784f5dAvailable 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
67877-609-05Dapagliflozin500 in 1 BOTTLETABLET, FILM COATED5009
67877-609-30Dapagliflozin30 in 1 BOTTLETABLET, FILM COATED309
67877-609-33Dapagliflozin1 in 1 CARTONTABLET, FILM COATED19
67877-609-33Dapagliflozin10 in 1 BLISTER PACKTABLET, FILM COATED109
67877-609-90Dapagliflozin90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-609-30EA - Each67877-609a255e5f8-17e6-45d8-8c1f-2184cf0c5d6912026-05-22
67877-609-90EA - Each67877-6096fe78d38-f556-400d-9877-a20c9c946d4512026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSNb6b8a10c-64c3-4856-8961-d72d68784f5d9
1488574dapagliflozin 5 MG Oral TabletPSNb6b8a10c-64c3-4856-8961-d72d68784f5d9
1488569dapagliflozin 10 MG Oral TabletSCDb6b8a10c-64c3-4856-8961-d72d68784f5d9
1488574dapagliflozin 5 MG Oral TabletSCDb6b8a10c-64c3-4856-8961-d72d68784f5d9
1488569dapagliflozin 10 MG Oral TabletSYb6b8a10c-64c3-4856-8961-d72d68784f5d9
1488574dapagliflozin 5 MG Oral TabletSYb6b8a10c-64c3-4856-8961-d72d68784f5d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67877-609-0567877060905500 TABLET, FILM COATED in 1 BOTTLE (67877-609-05) 2026-04-06NoNoCurrent
67877-609-306787706093030 TABLET, FILM COATED in 1 BOTTLE (67877-609-30) 2026-04-06NoNoCurrent
67877-609-33678770609331 BLISTER PACK in 1 CARTON (67877-609-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2026-04-06NoNoCurrent
67877-609-906787706099090 TABLET, FILM COATED in 1 BOTTLE (67877-609-90) 2026-04-06NoNoCurrent