Dapagliflozin

Product NDC
73190-072
11-digit product format
731900072
Labeler code
73190
Product ID
73190-072_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
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
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
73190-072-30Dapagliflozin30 in 1 BOTTLETABLET, FILM COATED302
73190-072-90Dapagliflozin90 in 1 BOTTLETABLET, FILM COATED902

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
73190-072-307319000723030 TABLET, FILM COATED in 1 BOTTLE (73190-072-30) 2026-05-25NoNoHistorical
73190-072-907319000729090 TABLET, FILM COATED in 1 BOTTLE (73190-072-90) 2026-05-25NoNoHistorical