Dapagliflozin

Product NDC
27241-152
11-digit product format
272410152
Labeler code
27241
Product ID
27241-152_fcd0842f-0101-4e91-93db-ca734189540b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapagliflozin
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA211482
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, 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
27241-152-01Dapagliflozin30 in 1 BOTTLETABLET3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-152-01EA - Each27241-152bcbf7f49-781c-4ff0-9c25-36ad4729791e12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSNf615d81e-d1e8-4561-a4d9-286c615d3bd210
1488574dapagliflozin 5 MG Oral TabletPSNf615d81e-d1e8-4561-a4d9-286c615d3bd210
1488569dapagliflozin 10 MG Oral TabletSCDf615d81e-d1e8-4561-a4d9-286c615d3bd210
1488574dapagliflozin 5 MG Oral TabletSCDf615d81e-d1e8-4561-a4d9-286c615d3bd210
1488569dapagliflozin 10 MG Oral TabletSYf615d81e-d1e8-4561-a4d9-286c615d3bd210
1488574dapagliflozin 5 MG Oral TabletSYf615d81e-d1e8-4561-a4d9-286c615d3bd210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
27241-152-012724101520130 TABLET in 1 BOTTLE (27241-152-01) 30 tablet2026-04-06NoNoHistorical