jardiance

Generic: empagliflozin

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name jardiance
Generic Name empagliflozin
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

empagliflozin 25 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-0412
Product ID 55154-0412_9c209f5c-9a8e-40bf-abed-1b36b368c271
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204629
Listing Expiration 2027-12-31
Marketing Start 2014-08-01

Pharmacologic Class

Established (EPC)
sodium-glucose cotransporter 2 inhibitor [epc]
Mechanism of Action
sodium-glucose transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551540412
Hyphenated Format 55154-0412

Supplemental Identifiers

RxCUI
1545658 1545664 1545666 1545668
UPC
0305970153306
UNII
HDC1R2M35U
NUI
N0000187059 N0000187058

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name jardiance (source: ndc)
Generic Name empagliflozin (source: ndc)
Application Number NDA204629 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0412-8)
source: ndc

Packages (1)

55154-0412-8 990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0412-8)

Ingredients (1)

empagliflozin (25 mg/1)

Linked Drug Pages (1)

Jardiance ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9c209f5c-9a8e-40bf-abed-1b36b368c271", "openfda": {"nui": ["N0000187059", "N0000187058"], "upc": ["0305970153306"], "unii": ["HDC1R2M35U"], "rxcui": ["1545658", "1545664", "1545666", "1545668"], "spl_set_id": ["5777b8a8-ada6-4950-8548-43a1de11f075"], "pharm_class_epc": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0412-8)", "package_ndc": "55154-0412-8", "marketing_start_date": "20140801"}], "brand_name": "Jardiance", "product_id": "55154-0412_9c209f5c-9a8e-40bf-abed-1b36b368c271", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "55154-0412", "generic_name": "Empagliflozin", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Jardiance", "active_ingredients": [{"name": "EMPAGLIFLOZIN", "strength": "25 mg/1"}], "application_number": "NDA204629", "marketing_category": "NDA", "marketing_start_date": "20140801", "listing_expiration_date": "20271231"}