JARDIANCE

Product NDC
50090-6452
11-digit product format
500906452
Labeler code
50090
Product ID
50090-6452_46a68ec5-d52b-46dd-920f-38eff4165301
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
50090-6452-0JARDIANCE90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6452-0EA - Each50090-6452b34d114a-6fcb-44e3-89fe-d8bb92df101b12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6452JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20230504_1782b947-4a72-4feb-a488-1469d9af82bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1545658empagliflozin 10 MG Oral TabletPSN1782b947-4a72-4feb-a488-1469d9af82bd1
1545664Jardiance 10 MG Oral TabletPSN1782b947-4a72-4feb-a488-1469d9af82bd1
1545664empagliflozin 10 MG Oral Tablet [Jardiance]SBD1782b947-4a72-4feb-a488-1469d9af82bd1
1545658empagliflozin 10 MG Oral TabletSCD1782b947-4a72-4feb-a488-1469d9af82bd1
1545664Jardiance 10 MG Oral TabletSY1782b947-4a72-4feb-a488-1469d9af82bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6452-05009064520090 TABLET, FILM COATED in 1 BOTTLE (50090-6452-0) 2023-04-27NoNoCurrent