FARXIGA

Product NDC
50090-3481
11-digit product format
500903481
Labeler code
50090
Product ID
50090-3481_de360b4e-6a91-4439-9f4d-475de2d8f08b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPAGLIFLOZIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA202293
Marketing category
NDA
Marketing start
2008-01-14
Substance
DAPAGLIFLOZIN PROPANEDIOL
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FARXIGA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN PROPANEDIOL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii887K2391VH
Rxcui1486977, 1486981, 1488569, 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
50090-3481-0FARXIGA30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3481-0EA - Each50090-3481a7f66f4c-b0b7-41eb-bcf3-8d25792416f512021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3481FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 1 package rows20231213_01f90c94-71cb-4a1f-81ff-8004b850529b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSN01f90c94-71cb-4a1f-81ff-8004b850529b15
1488574dapagliflozin 5 MG Oral TabletPSN01f90c94-71cb-4a1f-81ff-8004b850529b15
1486977farxiga 10 MG Oral TabletPSN01f90c94-71cb-4a1f-81ff-8004b850529b15
1486981farxiga 5 MG Oral TabletPSN01f90c94-71cb-4a1f-81ff-8004b850529b15
1486977dapagliflozin 10 MG Oral Tablet [Farxiga]SBD01f90c94-71cb-4a1f-81ff-8004b850529b15
1486981dapagliflozin 5 MG Oral Tablet [Farxiga]SBD01f90c94-71cb-4a1f-81ff-8004b850529b15
1488569dapagliflozin 10 MG Oral TabletSCD01f90c94-71cb-4a1f-81ff-8004b850529b15
1488574dapagliflozin 5 MG Oral TabletSCD01f90c94-71cb-4a1f-81ff-8004b850529b15
1488569dapagliflozin 10 MG Oral TabletSY01f90c94-71cb-4a1f-81ff-8004b850529b15
1488574dapagliflozin 5 MG Oral TabletSY01f90c94-71cb-4a1f-81ff-8004b850529b15
1486977Farxiga 10 MG Oral TabletSY01f90c94-71cb-4a1f-81ff-8004b850529b15
1486981Farxiga 5 MG Oral TabletSY01f90c94-71cb-4a1f-81ff-8004b850529b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3481-05009034810030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3481-0) 2018-06-150000-00-00NoNoCurrent