DAPAGLIFLOZIN

Product NDC
62332-392
11-digit product format
623320392
Labeler code
62332
Product ID
62332-392_befb2492-ced0-4523-9051-6d766b2fdb69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPAGLIFLOZIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA211560
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
62332-392-306233203923030 TABLET, FILM COATED in 1 BOTTLE (62332-392-30) 2026-04-06NoNoHistorical
62332-392-91623320392911000 TABLET, FILM COATED in 1 BOTTLE (62332-392-91) 2026-04-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DAPAGLIFLOZINAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2026-04-07Human Prescription Drug Label11