FDA.reportPublic FDA data

Jardiance

Product NDC
71610-177
11-digit product format
716100177
Labeler code
71610
Product ID
71610-177_422a084f-5495-2335-e063-6394a90a8736
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
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
71610-177-09Jardiance9000 in 1 BOTTLETABLET, FILM COATED90004
71610-177-15Jardiance15 in 1 BOTTLETABLET, FILM COATED154
71610-177-42Jardiance1800 in 1 BOTTLETABLET, FILM COATED18004
71610-177-45Jardiance45 in 1 BOTTLETABLET, FILM COATED454
71610-177-81Jardiance1080 in 1 BOTTLETABLET, FILM COATED10804
71610-177-99Jardiance5040 in 1 BOTTLETABLET, FILM COATED50404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-177-09EA - Each71610-177d7d7e785-3b97-4c2e-b84f-2914fc2c9ed712019-01-24
71610-177-15EA - Each71610-177396baa66-67ca-42e9-9106-d315afc3cb3f12025-05-14
71610-177-42EA - Each71610-177e59fc200-04a1-4820-a0b6-276f6d8db68212023-08-08
71610-177-45EA - Each71610-177f8f3e3ec-9110-469d-96dd-23eda06cd67612025-05-14
71610-177-81EA - Each71610-17752083dde-55c2-4cf0-b302-3fdae2c841ab12025-06-13
71610-177-99EA - Each71610-1772c04ed69-bd2a-4912-9c70-afb0bfc1ac5912025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-177JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 6 package rows20250429_8b6261f6-4bdc-462e-8af1-4064664c62f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1545666empagliflozin 25 MG Oral TabletPSN8b6261f6-4bdc-462e-8af1-4064664c62f34
1545668Jardiance 25 MG Oral TabletPSN8b6261f6-4bdc-462e-8af1-4064664c62f34
1545668empagliflozin 25 MG Oral Tablet [Jardiance]SBD8b6261f6-4bdc-462e-8af1-4064664c62f34
1545666empagliflozin 25 MG Oral TabletSCD8b6261f6-4bdc-462e-8af1-4064664c62f34
1545668Jardiance 25 MG Oral TabletSY8b6261f6-4bdc-462e-8af1-4064664c62f34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-177-09716100177099000 TABLET, FILM COATED in 1 BOTTLE (71610-177-09) 2018-10-240000-00-00NoNoCurrent
71610-177-157161001771515 TABLET, FILM COATED in 1 BOTTLE (71610-177-15) 2019-09-18NoNoHistorical
71610-177-42716100177421800 TABLET, FILM COATED in 1 BOTTLE (71610-177-42) 2022-12-090000-00-00NoNoCurrent
71610-177-457161001774545 TABLET, FILM COATED in 1 BOTTLE (71610-177-45) 2019-10-03NoNoHistorical
71610-177-81716100177811080 TABLET, FILM COATED in 1 BOTTLE (71610-177-81) 2025-04-22NoNoHistorical
71610-177-99716100177995040 TABLET, FILM COATED in 1 BOTTLE (71610-177-99) 2025-10-27NoNoHistorical