jardiance

Generic: empagliflozin

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name jardiance
Generic Name empagliflozin
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

empagliflozin 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-177
Product ID 71610-177_422a084f-5495-2335-e063-6394a90a8736
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204629
Listing Expiration 2026-12-31
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 71610177
Hyphenated Format 71610-177

Supplemental Identifiers

RxCUI
1545666 1545668
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
  • 9000 TABLET, FILM COATED in 1 BOTTLE (71610-177-09)
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-177-15)
  • 1800 TABLET, FILM COATED in 1 BOTTLE (71610-177-42)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-177-45)
  • 1080 TABLET, FILM COATED in 1 BOTTLE (71610-177-81)
  • 5040 TABLET, FILM COATED in 1 BOTTLE (71610-177-99)
source: ndc

Packages (6)

71610-177-09 9000 TABLET, FILM COATED in 1 BOTTLE (71610-177-09) 71610-177-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-177-15) 71610-177-42 1800 TABLET, FILM COATED in 1 BOTTLE (71610-177-42) 71610-177-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-177-45) 71610-177-81 1080 TABLET, FILM COATED in 1 BOTTLE (71610-177-81) 71610-177-99 5040 TABLET, FILM COATED in 1 BOTTLE (71610-177-99)

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": "422a084f-5495-2335-e063-6394a90a8736", "openfda": {"nui": ["N0000187059", "N0000187058"], "unii": ["HDC1R2M35U"], "rxcui": ["1545666", "1545668"], "spl_set_id": ["8b6261f6-4bdc-462e-8af1-4064664c62f3"], "pharm_class_epc": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 TABLET, FILM COATED in 1 BOTTLE (71610-177-09)", "package_ndc": "71610-177-09", "marketing_start_date": "20181024"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-177-15)", "package_ndc": "71610-177-15", "marketing_start_date": "20190918"}, {"sample": false, "description": "1800 TABLET, FILM COATED in 1 BOTTLE (71610-177-42)", "package_ndc": "71610-177-42", "marketing_start_date": "20221209"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-177-45)", "package_ndc": "71610-177-45", "marketing_start_date": "20191003"}, {"sample": false, "description": "1080 TABLET, FILM COATED in 1 BOTTLE (71610-177-81)", "package_ndc": "71610-177-81", "marketing_start_date": "20250422"}, {"sample": false, "description": "5040 TABLET, FILM COATED in 1 BOTTLE (71610-177-99)", "package_ndc": "71610-177-99", "marketing_start_date": "20251027"}], "brand_name": "Jardiance", "product_id": "71610-177_422a084f-5495-2335-e063-6394a90a8736", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "71610-177", "generic_name": "Empagliflozin", "labeler_name": "Aphena Pharma Solutions - Tennessee, 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": "20261231"}