Saxenda
These highlights do not include all the information needed to use SAXENDA safely and effectively. See full prescribing information for SAXENDA.SAXENDA (liraglutide) injection, for subcutaneous useInitial U.S. Approval: 2010
Approved
Approval ID
7b11f6ac-4c27-4748-9e65-22d4cf3adfb4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2024
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
liraglutide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-4257
Application NumberNDA206321
Product Classification
M
Marketing Category
C73594
G
Generic Name
liraglutide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 20, 2023
FDA Product Classification
INGREDIENTS (7)
LIRAGLUTIDEActive
Quantity: 6 mg in 1 mL
Code: 839I73S42A
Classification: ACTIB
PROPYLENE GLYCOLInactive
Quantity: 14 mg in 1 mL
Code: 6DC9Q167V3
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 1.42 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
PHENOLInactive
Quantity: 5.5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM