glyxambi

Generic: empagliflozin and linagliptin

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

Drug Facts

Product Profile

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

empagliflozin 25 mg/1, linagliptin 5 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0164
Product ID 0597-0164_16f275d5-7526-4e7a-8776-665a9a6ae37a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206073
Listing Expiration 2027-12-31
Marketing Start 2015-01-30

Pharmacologic Class

Established (EPC)
sodium-glucose cotransporter 2 inhibitor [epc] dipeptidyl peptidase 4 inhibitor [epc]
Mechanism of Action
sodium-glucose transporter 2 inhibitors [moa] dipeptidyl peptidase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970164
Hyphenated Format 0597-0164

Supplemental Identifiers

RxCUI
1602109 1602115 1602118 1602120
UNII
HDC1R2M35U 3X29ZEJ4R2
NUI
N0000187059 N0000187058 N0000175912 N0000175913

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 glyxambi (source: ndc)
Generic Name empagliflozin and linagliptin (source: ndc)
Application Number NDA206073 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0597-0164-30)
  • 30 BLISTER PACK in 1 CARTON (0597-0164-39) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 90 TABLET, FILM COATED in 1 BOTTLE (0597-0164-90)
source: ndc

Packages (3)

0597-0164-30 30 TABLET, FILM COATED in 1 BOTTLE (0597-0164-30) 0597-0164-39 30 BLISTER PACK in 1 CARTON (0597-0164-39) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0597-0164-90 90 TABLET, FILM COATED in 1 BOTTLE (0597-0164-90)

Ingredients (2)

empagliflozin (25 mg/1) linagliptin (5 mg/1)

Linked Drug Pages (1)

Glyxambi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "16f275d5-7526-4e7a-8776-665a9a6ae37a", "openfda": {"nui": ["N0000187059", "N0000187058", "N0000175912", "N0000175913"], "unii": ["HDC1R2M35U", "3X29ZEJ4R2"], "rxcui": ["1602109", "1602115", "1602118", "1602120"], "spl_set_id": ["ddbab689-f76c-488c-9613-4168d41dd730"], "pharm_class_epc": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Sodium-Glucose Transporter 2 Inhibitors [MoA]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0597-0164-30)", "package_ndc": "0597-0164-30", "marketing_start_date": "20150130"}, {"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0597-0164-39)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0597-0164-39", "marketing_start_date": "20150130"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0597-0164-90)", "package_ndc": "0597-0164-90", "marketing_start_date": "20150130"}], "brand_name": "Glyxambi", "product_id": "0597-0164_16f275d5-7526-4e7a-8776-665a9a6ae37a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]", "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "0597-0164", "generic_name": "empagliflozin and linagliptin", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glyxambi", "active_ingredients": [{"name": "EMPAGLIFLOZIN", "strength": "25 mg/1"}, {"name": "LINAGLIPTIN", "strength": "5 mg/1"}], "application_number": "NDA206073", "marketing_category": "NDA", "marketing_start_date": "20150130", "listing_expiration_date": "20271231"}