Dapagliflozin

Product NDC
50090-7971
11-digit product format
500907971
Labeler code
50090
Product ID
50090-7971_a927d507-82ba-4f9b-bb5a-6ee0f6cba923
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
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
1ULL0QJ8UCDAPAGLIFLOZIN461432-26-8DAPAGLIFLOZIN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7971-05009079710030 TABLET, FILM COATED in 1 BOTTLE (50090-7971-0) 2026-05-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DapagliflozinA-S Medication Solutions2026-05-18Human Prescription Drug Label1