Xultophy 100/3.6
These highlights do not include all the information needed to use XULTOPHY 100/3.6 safely and effectively. See full prescribing information for . Initial U.S. Approval: 2016
Approved
Approval ID
21335fe4-d395-4501-ac2a-2f20d7520da9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 10, 2023
Manufacturers
FDA
Novo Nordisk
DUNS: 622920320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
(insulin degludec and liraglutide)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-2911
Application NumberBLA208583
Product Classification
M
Marketing Category
C73585
G
Generic Name
(insulin degludec and liraglutide)
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJune 10, 2022
FDA Product Classification
INGREDIENTS (8)
INSULIN DEGLUDECActive
Quantity: 100 [iU] in 1 mL
Code: 54Q18076QB
Classification: ACTIB
LIRAGLUTIDEActive
Quantity: 3.6 mg in 1 mL
Code: 839I73S42A
Classification: ACTIB
GLYCERINInactive
Quantity: 19.7 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
ZINCInactive
Quantity: 55 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Quantity: 5.70 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM