FDA.reportPublic FDA data

Saxenda

Product NDC
0169-2800
11-digit product format
001692800
Labeler code
0169
Product ID
0169-2800_eba7f5c9-44d0-4549-ae94-daa2c5181646
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
liraglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk
Application
NDA206321
Marketing category
NDA
Marketing start
2014-12-31
Substance
LIRAGLUTIDE
Active strength
6 mg/mL
Pharmacologic classes
GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Saxenda
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIRAGLUTIDE6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii839I73S42A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d8dac6c8-0045-42cf-b357-c3350b4ada5cProduct name220251021
0dd952e2-ff48-4739-9b8d-72ae0b326834Product name220200323
ce962b7e-f9f8-43e6-8d30-41514e79f3e4Product name120190201
2f360a13-6ea8-4c2b-b2ef-10133c2836d9Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-2800-15Saxenda3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION321
0169-2800-15Saxenda5 in 1 CARTONINJECTION, SOLUTION521
0169-2800-90Saxenda3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION321
0169-2800-90Saxenda1 in 1 CARTONINJECTION, SOLUTION121
0169-2800-97Saxenda1 in 1 CARTONINJECTION, SOLUTION121
0169-2800-97Saxenda3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION321

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-2800-15ML - Milliliter0169-2800fd933a1a-3db7-4f15-8372-f314a6550bcb12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIRAGLUTIDEACTIVE INGREDIENT839I73S42ASAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK]4
LIRAGLUTIDEACTIVE MOIETY839I73S42ASAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK]4
PHENOLINACTIVE INGREDIENT339NCG44TVSAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK]4
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TSAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK]4
WATERINACTIVE INGREDIENT059QF0KO0RSAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-2800SAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK]18Current NDC, Legacy NDC, 6 package rows20241115_3946d389-0926-4f77-a708-0acb8153b143.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2735350liraglutide 6 MG/ML in 3 mL Weight Management Pen InjectorPSN3946d389-0926-4f77-a708-0acb8153b14321
1598268Saxenda 6 MG/ML in 3 mL Weight Management Pen InjectorPSN3946d389-0926-4f77-a708-0acb8153b14321
1598268Weight Management 3 ML liraglutide 6 MG/ML Pen Injector [Saxenda]SBD3946d389-0926-4f77-a708-0acb8153b14321
2735350Weight Management 3 ML liraglutide 6 MG/ML Pen InjectorSCD3946d389-0926-4f77-a708-0acb8153b14321
15982683 ML Saxenda 6 MG/ML Weight Management Pen InjectorSY3946d389-0926-4f77-a708-0acb8153b14321
2735350liraglutide 18 MG per 3 ML Weight Management Pen InjectorSY3946d389-0926-4f77-a708-0acb8153b14321
1598268Saxenda 18 MG per 3 ML Weight Management Pen InjectorSY3946d389-0926-4f77-a708-0acb8153b14321
1598268Weight Management Saxenda 6 MG/ML Pen InjectorSY3946d389-0926-4f77-a708-0acb8153b14321
2735350liraglutide 6 MG/ML in 3 mL Weight Management Pen InjectorPSN7b11f6ac-4c27-4748-9e65-22d4cf3adfb46
1598268Saxenda 6 MG/ML in 3 mL Weight Management Pen InjectorPSN7b11f6ac-4c27-4748-9e65-22d4cf3adfb46
1598268Weight Management 3 ML liraglutide 6 MG/ML Pen Injector [Saxenda]SBD7b11f6ac-4c27-4748-9e65-22d4cf3adfb46
2735350Weight Management 3 ML liraglutide 6 MG/ML Pen InjectorSCD7b11f6ac-4c27-4748-9e65-22d4cf3adfb46
15982683 ML Saxenda 6 MG/ML Weight Management Pen InjectorSY7b11f6ac-4c27-4748-9e65-22d4cf3adfb46
2735350liraglutide 18 MG per 3 ML Weight Management Pen InjectorSY7b11f6ac-4c27-4748-9e65-22d4cf3adfb46
1598268Saxenda 18 MG per 3 ML Weight Management Pen InjectorSY7b11f6ac-4c27-4748-9e65-22d4cf3adfb46
1598268Weight Management Saxenda 6 MG/ML Pen InjectorSY7b11f6ac-4c27-4748-9e65-22d4cf3adfb46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0169-2800-15001692800155 SYRINGE, PLASTIC in 1 CARTON (0169-2800-15) / 3 mL in 1 SYRINGE, PLASTIC2015-01-190000-00-00NoNoCurrent
0169-2800-90001692800901 SYRINGE, PLASTIC in 1 CARTON (0169-2800-90) / 3 mL in 1 SYRINGE, PLASTIC2015-01-190000-00-00NoNoCurrent
0169-2800-97001692800971 SYRINGE, PLASTIC in 1 CARTON (0169-2800-97) / 3 mL in 1 SYRINGE, PLASTIC2015-01-190000-00-00NoNoCurrent