FDA.reportPublic FDA data

Saxenda

Product NDC
50090-4257
11-digit product format
500904257
Labeler code
50090
Product ID
50090-4257_f65e201b-a65f-4e28-af27-5292380ee09d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
liraglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Saxenda
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIRAGLUTIDE6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii839I73S42A
Rxcui1598268, 2735350

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4257-02024-01-29C16284748780-1f386c649-de7e-0266-e053-dadaa90a7c1aThese 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 use Initial U.S. Approval: 2010
50090-4257-02023-01-30C16284748780-1f386c649-de7e-0266-e053-dadaa90a7c1aThese 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 use Initial U.S. Approval: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4257-0Saxenda3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION36
50090-4257-0Saxenda5 in 1 CARTONINJECTION, SOLUTION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4257-0ML - Milliliter50090-42576987eafd-0586-4701-8845-3cb1fcc5a69f12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4257SAXENDA (LIRAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20240131_7b11f6ac-4c27-4748-9e65-22d4cf3adfb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
50090-4257-0500904257005 SYRINGE, PLASTIC in 1 CARTON (50090-4257-0) / 3 mL in 1 SYRINGE, PLASTIC2019-04-090000-00-00NoNoCurrent