FDA.reportPublic FDA data

Victoza

Product NDC
50090-4503
11-digit product format
500904503
Labeler code
50090
Product ID
50090-4503_a934a344-0ee2-420c-980c-ae69581875fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
liraglutide
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
NDA022341
Marketing category
NDA
Marketing start
2010-01-25
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
Victoza
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIRAGLUTIDE6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii839I73S42A
Rxcui897122, 897126

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
50090-4503-02023-02-07C16284748780-1f386c649-affc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VICTOZA safely and effectively. See full prescribing information for VICTOZA. VICTOZA ® (liraglutide) injection, for subcutaneous use Initial U.S. Approval: 2010
50090-4503-02023-01-30C16284748780-1f386c649-affc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VICTOZA safely and effectively. See full prescribing information for VICTOZA. VICTOZA ® (liraglutide) injection, for subcutaneous use Initial U.S. Approval: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4503-0Victoza3 mL in 1 SYRINGE, PLASTICINJECTION35
50090-4503-0Victoza3 in 1 CARTONINJECTION35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4503-0ML - Milliliter50090-45037d381500-a536-40c7-a729-5325d81d77b312022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4503VICTOZA (LIRAGLUTIDE) INJECTION [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230208_35e613e3-7aae-4152-b827-99d1ee7841be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897122liraglutide 6 MG/ML in 3 ML Pen InjectorPSN35e613e3-7aae-4152-b827-99d1ee7841be5
897126Victoza 6 MG/ML in 3 ML Pen InjectorPSN35e613e3-7aae-4152-b827-99d1ee7841be5
8971263 ML liraglutide 6 MG/ML Pen Injector [Victoza]SBD35e613e3-7aae-4152-b827-99d1ee7841be5
8971223 ML liraglutide 6 MG/ML Pen InjectorSCD35e613e3-7aae-4152-b827-99d1ee7841be5
8971263 ML Victoza 6 MG/ML Pen InjectorSY35e613e3-7aae-4152-b827-99d1ee7841be5
897122liraglutide 18 MG per 3 ML Pen InjectorSY35e613e3-7aae-4152-b827-99d1ee7841be5
897126Victoza 18 MG per 3 ML Pen InjectorSY35e613e3-7aae-4152-b827-99d1ee7841be5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4503-0500904503003 SYRINGE, PLASTIC in 1 CARTON (50090-4503-0) / 3 mL in 1 SYRINGE, PLASTIC2019-09-040000-00-00NoNoCurrent