Jardiance

Product NDC
55154-0412
11-digit product format
551540412
Labeler code
55154
Product ID
55154-0412_9c209f5c-9a8e-40bf-abed-1b36b368c271
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Empagliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Jardiance
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMPAGLIFLOZIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDC1R2M35U
Rxcui1545658, 1545664, 1545666, 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
55154-0412-8Jardiance990 in 1 BOTTLE, PLASTICTABLET, FILM COATED99013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-0412-8EA - Each55154-04122ab53912-711e-4ef6-81c9-649357c15db612024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-0412JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]11Current NDC, Legacy NDC, 1 package rows20250503_5777b8a8-ada6-4950-8548-43a1de11f075.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1545658empagliflozin 10 MG Oral TabletPSN5777b8a8-ada6-4950-8548-43a1de11f07513
1545666empagliflozin 25 MG Oral TabletPSN5777b8a8-ada6-4950-8548-43a1de11f07513
1545664Jardiance 10 MG Oral TabletPSN5777b8a8-ada6-4950-8548-43a1de11f07513
1545668Jardiance 25 MG Oral TabletPSN5777b8a8-ada6-4950-8548-43a1de11f07513
1545664empagliflozin 10 MG Oral Tablet [Jardiance]SBD5777b8a8-ada6-4950-8548-43a1de11f07513
1545668empagliflozin 25 MG Oral Tablet [Jardiance]SBD5777b8a8-ada6-4950-8548-43a1de11f07513
1545658empagliflozin 10 MG Oral TabletSCD5777b8a8-ada6-4950-8548-43a1de11f07513
1545666empagliflozin 25 MG Oral TabletSCD5777b8a8-ada6-4950-8548-43a1de11f07513
1545664Jardiance 10 MG Oral TabletSY5777b8a8-ada6-4950-8548-43a1de11f07513
1545668Jardiance 25 MG Oral TabletSY5777b8a8-ada6-4950-8548-43a1de11f07513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-0412-855154041208990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0412-8) 2014-08-010000-00-00NoNoCurrent