FDA.reportPublic FDA data

Jardiance

Product NDC
71610-900
11-digit product format
716100900
Labeler code
71610
Product ID
71610-900_334f174d-fe96-517d-e063-6394a90a8d4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Empagliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
71610-900-09Jardiance9000 in 1 BOTTLETABLET, FILM COATED90001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-900-09EA - Each71610-900c26e3acf-7015-4ad8-a9c8-b5c18c7bbe2912025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-900JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 1 package rows20250424_334f1b3d-5670-6685-e063-6294a90a7e47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1545658empagliflozin 10 MG Oral TabletPSN334f1b3d-5670-6685-e063-6294a90a7e471
1545664Jardiance 10 MG Oral TabletPSN334f1b3d-5670-6685-e063-6294a90a7e471
1545664empagliflozin 10 MG Oral Tablet [Jardiance]SBD334f1b3d-5670-6685-e063-6294a90a7e471
1545658empagliflozin 10 MG Oral TabletSCD334f1b3d-5670-6685-e063-6294a90a7e471
1545664Jardiance 10 MG Oral TabletSY334f1b3d-5670-6685-e063-6294a90a7e471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-900-09716100900099000 TABLET, FILM COATED in 1 BOTTLE (71610-900-09) 2025-04-17NoNoHistorical