FDA.reportPublic FDA data

JARDIANCE

Product NDC
50090-4492
11-digit product format
500904492
Labeler code
50090
Product ID
50090-4492_1415572d-8ed7-4dc7-9506-764952ce7438
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
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
JARDIANCE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMPAGLIFLOZIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDC1R2M35U
Rxcui1545658, 1545664

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
50090-4492-0JARDIANCE90 in 1 BOTTLETABLET, FILM COATED909
50090-4492-1JARDIANCE30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4492-0EA - Each50090-44929d5e3fe5-3aef-4567-a1d3-4580a6bfe9ed12022-07-06
50090-4492-1EA - Each50090-44925ba0147d-52d3-40aa-8623-219406fc35e512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4492JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20230725_942a82a4-cbbd-4e44-9965-8d03f767912b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1545658empagliflozin 10 MG Oral TabletPSN942a82a4-cbbd-4e44-9965-8d03f767912b9
1545664Jardiance 10 MG Oral TabletPSN942a82a4-cbbd-4e44-9965-8d03f767912b9
1545664empagliflozin 10 MG Oral Tablet [Jardiance]SBD942a82a4-cbbd-4e44-9965-8d03f767912b9
1545658empagliflozin 10 MG Oral TabletSCD942a82a4-cbbd-4e44-9965-8d03f767912b9
1545664Jardiance 10 MG Oral TabletSY942a82a4-cbbd-4e44-9965-8d03f767912b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4492-05009044920090 TABLET, FILM COATED in 1 BOTTLE (50090-4492-0) 2019-08-290000-00-00NoNoCurrent
50090-4492-15009044920130 TABLET, FILM COATED in 1 BOTTLE (50090-4492-1) 2023-07-18NoNoHistorical