FDA.reportPublic FDA data

dapagliflozin

Product NDC
33342-585
11-digit product format
333420585
Labeler code
33342
Product ID
33342-585_4fa5c1b8-9912-4fb8-a3b9-c105fbf641a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dapagliflozin
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA211506
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

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
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
33342-585-07dapagliflozin30 in 1 BOTTLETABLET302
33342-585-10dapagliflozin90 in 1 BOTTLETABLET902
33342-585-12dapagliflozin10 in 1 CARTONTABLET102
33342-585-66dapagliflozin10 in 1 BLISTER PACKTABLET102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSN91373924-66dc-4277-aaf2-8536e81a0e4d2
1488574dapagliflozin 5 MG Oral TabletPSN91373924-66dc-4277-aaf2-8536e81a0e4d2
1488569dapagliflozin 10 MG Oral TabletSCD91373924-66dc-4277-aaf2-8536e81a0e4d2
1488574dapagliflozin 5 MG Oral TabletSCD91373924-66dc-4277-aaf2-8536e81a0e4d2
1488569dapagliflozin 10 MG Oral TabletSY91373924-66dc-4277-aaf2-8536e81a0e4d2
1488574dapagliflozin 5 MG Oral TabletSY91373924-66dc-4277-aaf2-8536e81a0e4d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-585-073334205850730 TABLET in 1 BOTTLE (33342-585-07) 30 tablet2026-04-06NoNoCurrent
33342-585-103334205851090 TABLET in 1 BOTTLE (33342-585-10) 90 tablet2026-04-06NoNoCurrent
33342-585-123334205851210 BLISTER PACK in 1 CARTON (33342-585-12) / 10 TABLET in 1 BLISTER PACK (33342-585-66) 10 blister pack2026-04-06NoNoCurrent
33342-585-663334205856610 in 1 BLISTER PACKHistorical