FDA.reportPublic FDA data

Jardiance

Product NDC
50090-4384
11-digit product format
500904384
Labeler code
50090
Product ID
50090-4384_3d4cc600-beb6-4409-b15e-2014a2d94363
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Empagliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA204629
Marketing category
NDA
Marketing start
2014-08-01
Substance
EMPAGLIFLOZIN
Active strength
25 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
Jardiance
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMPAGLIFLOZIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDC1R2M35U
Rxcui1545666, 1545668

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
a1e505bd-ab91-46e4-b7bc-a43a10199330Product name220170214
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
24acbc89-fd6a-458c-aa62-a3485b119bedProduct name120150323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4384-0Jardiance90 in 1 BOTTLETABLET, FILM COATED9011
50090-4384-1Jardiance30 in 1 BOTTLETABLET, FILM COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4384-0EA - Each50090-4384e7de6865-29e0-46e6-b849-2118cc87f0c412022-07-06
50090-4384-1EA - Each50090-438432b9c172-5f76-4a2c-95d5-2b38cd0ccf3412023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4384JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 package rows20230810_a77214ca-572e-485e-aae9-f7950187e5fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1545666empagliflozin 25 MG Oral TabletPSNa77214ca-572e-485e-aae9-f7950187e5fb11
1545668Jardiance 25 MG Oral TabletPSNa77214ca-572e-485e-aae9-f7950187e5fb11
1545668empagliflozin 25 MG Oral Tablet [Jardiance]SBDa77214ca-572e-485e-aae9-f7950187e5fb11
1545666empagliflozin 25 MG Oral TabletSCDa77214ca-572e-485e-aae9-f7950187e5fb11
1545668Jardiance 25 MG Oral TabletSYa77214ca-572e-485e-aae9-f7950187e5fb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4384-05009043840090 TABLET, FILM COATED in 1 BOTTLE (50090-4384-0) 2019-06-250000-00-00NoNoCurrent
50090-4384-15009043840130 TABLET, FILM COATED in 1 BOTTLE (50090-4384-1) 2023-08-06NoNoHistorical