xultophy 100/3.6

Generic: insulin degludec and liraglutide

Labeler: novo nordisk
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name xultophy 100/3.6
Generic Name insulin degludec and liraglutide
Labeler novo nordisk
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin degludec 100 [iU]/mL, liraglutide 3.6 mg/mL

Manufacturer
Novo Nordisk

Identifiers & Regulatory

Product NDC 0169-2911
Product ID 0169-2911_7ade72ef-d354-430d-afad-3b63b95f5b39
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA208583
Listing Expiration 2026-12-31
Marketing Start 2016-11-21

Pharmacologic Class

Established (EPC)
insulin analog [epc] glp-1 receptor agonist [epc]
Mechanism of Action
glucagon-like peptide-1 (glp-1) agonists [moa]
Chemical Structure
insulin [cs] glucagon-like peptide 1 [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01692911
Hyphenated Format 0169-2911

Supplemental Identifiers

RxCUI
1860167 1860172
UNII
54Q18076QB 839I73S42A
NUI
M0011417 N0000175453 N0000178480 M0160181 N0000020058

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 xultophy 100/3.6 (source: ndc)
Generic Name insulin degludec and liraglutide (source: ndc)
Application Number BLA208583 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 [iU]/mL
  • 3.6 mg/mL
source: ndc
Packaging
  • 5 SYRINGE, PLASTIC in 1 CARTON (0169-2911-15) / 3 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (1)

0169-2911-15 5 SYRINGE, PLASTIC in 1 CARTON (0169-2911-15) / 3 mL in 1 SYRINGE, PLASTIC

Ingredients (2)

insulin degludec (100 [iU]/mL) liraglutide (3.6 mg/mL)

Linked Drug Pages (1)

Xultophy 100/3.6 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "7ade72ef-d354-430d-afad-3b63b95f5b39", "openfda": {"nui": ["M0011417", "N0000175453", "N0000178480", "M0160181", "N0000020058"], "unii": ["54Q18076QB", "839I73S42A"], "rxcui": ["1860167", "1860172"], "spl_set_id": ["21335fe4-d395-4501-ac2a-2f20d7520da9"], "pharm_class_cs": ["Insulin [CS]", "Glucagon-Like Peptide 1 [CS]"], "pharm_class_epc": ["Insulin Analog [EPC]", "GLP-1 Receptor Agonist [EPC]"], "pharm_class_moa": ["Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]"], "manufacturer_name": ["Novo Nordisk"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 SYRINGE, PLASTIC in 1 CARTON (0169-2911-15)  / 3 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0169-2911-15", "marketing_start_date": "20161121"}], "brand_name": "Xultophy 100/3.6", "product_id": "0169-2911_7ade72ef-d354-430d-afad-3b63b95f5b39", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["GLP-1 Receptor Agonist [EPC]", "Glucagon-Like Peptide 1 [CS]", "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]", "Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "0169-2911", "generic_name": "insulin degludec and liraglutide", "labeler_name": "Novo Nordisk", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xultophy 100/3.6", "active_ingredients": [{"name": "INSULIN DEGLUDEC", "strength": "100 [iU]/mL"}, {"name": "LIRAGLUTIDE", "strength": "3.6 mg/mL"}], "application_number": "BLA208583", "marketing_category": "BLA", "marketing_start_date": "20161121", "listing_expiration_date": "20261231"}