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
NDC Product Code0169-2911
Application NumberBLA208583
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateJune 10, 2022
Generic Name(insulin degludec and liraglutide)
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