FDA.reportPublic FDA data

Dapagliflozin

Product NDC
67877-608
11-digit product format
678770608
Labeler code
67877
Product ID
67877-608_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
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

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 Identifiers#

Field, Values table
FieldValues
Unii1ULL0QJ8UC
Rxcui1488569, 1488574

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
67877-608-05Dapagliflozin500 in 1 BOTTLETABLET, FILM COATED5009
67877-608-30Dapagliflozin30 in 1 BOTTLETABLET, FILM COATED309
67877-608-33Dapagliflozin10 in 1 BLISTER PACKTABLET, FILM COATED109
67877-608-33Dapagliflozin1 in 1 CARTONTABLET, FILM COATED19
67877-608-90Dapagliflozin90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-608-30EA - Each67877-6084eb27041-cf8e-4bb2-9f3c-d3956139643d12026-05-22
67877-608-90EA - Each67877-60867572de8-8f63-4e0d-a02a-0257d7a7c72812026-05-22

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
67877-608-0567877060805500 TABLET, FILM COATED in 1 BOTTLE (67877-608-05) 2026-04-06NoNoHistorical
67877-608-306787706083030 TABLET, FILM COATED in 1 BOTTLE (67877-608-30) 2026-04-06NoNoHistorical
67877-608-33678770608331 BLISTER PACK in 1 CARTON (67877-608-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2026-04-06NoNoHistorical
67877-608-906787706089090 TABLET, FILM COATED in 1 BOTTLE (67877-608-90) 2026-04-06NoNoHistorical