Dapagliflozin

Product NDC
50090-7972
11-digit product format
500907972
Labeler code
50090
Product ID
50090-7972_107fd3b4-6961-493e-a855-0e305ee2e9cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapagliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211468
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

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 Identifiers#

Field, Values table
FieldValues
Unii1ULL0QJ8UC
Rxcui1488569

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
50090-7972-0Dapagliflozin30 in 1 BOTTLETABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSNaddc6ead-f9e3-4b40-aed1-bc008a5c9b0f1
1488569dapagliflozin 10 MG Oral TabletSCDaddc6ead-f9e3-4b40-aed1-bc008a5c9b0f1
1488569dapagliflozin 10 MG Oral TabletSYaddc6ead-f9e3-4b40-aed1-bc008a5c9b0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7972-05009079720030 TABLET, FILM COATED in 1 BOTTLE (50090-7972-0) 2026-05-14NoNoCurrent