jardiance

Generic: empagliflozin

Labeler: boehringer ingelheim pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name jardiance
Generic Name empagliflozin
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

empagliflozin 25 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0153
Product ID 0597-0153_09daa78d-f417-436c-a29e-029c015ca6d6
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 05970153
Hyphenated Format 0597-0153

Supplemental Identifiers

RxCUI
1545658 1545664 1545666 1545668
UNII
HDC1R2M35U
NUI
N0000187059 N0000187058

Packaging Origin

Original Packager
true

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
  • 1 BOTTLE in 1 CARTON (0597-0153-07) / 7 TABLET, FILM COATED in 1 BOTTLE
  • 30 TABLET, FILM COATED in 1 BOTTLE (0597-0153-30)
  • 30 BLISTER PACK in 1 CARTON (0597-0153-37) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 90 TABLET, FILM COATED in 1 BOTTLE (0597-0153-90)
source: ndc

Packages (4)

0597-0153-07 1 BOTTLE in 1 CARTON (0597-0153-07) / 7 TABLET, FILM COATED in 1 BOTTLE 0597-0153-30 30 TABLET, FILM COATED in 1 BOTTLE (0597-0153-30) 0597-0153-37 30 BLISTER PACK in 1 CARTON (0597-0153-37) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0597-0153-90 90 TABLET, FILM COATED in 1 BOTTLE (0597-0153-90)

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": "09daa78d-f417-436c-a29e-029c015ca6d6", "openfda": {"nui": ["N0000187059", "N0000187058"], "unii": ["HDC1R2M35U"], "rxcui": ["1545658", "1545664", "1545666", "1545668"], "spl_set_id": ["faf3dd6a-9cd0-39c2-0d2e-232cb3f67565"], "pharm_class_epc": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (0597-0153-07)  / 7 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0597-0153-07", "marketing_start_date": "20140801"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0597-0153-30)", "package_ndc": "0597-0153-30", "marketing_start_date": "20140801"}, {"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0597-0153-37)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0597-0153-37", "marketing_start_date": "20140801"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0597-0153-90)", "package_ndc": "0597-0153-90", "marketing_start_date": "20140801"}], "brand_name": "Jardiance", "product_id": "0597-0153_09daa78d-f417-436c-a29e-029c015ca6d6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "0597-0153", "generic_name": "Empagliflozin", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "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"}