FDA.reportPublic FDA data

Victoza

Product NDC
0169-4060
11-digit product format
001694060
Labeler code
0169
Product ID
0169-4060_0d10d10e-0fe0-47ee-b9da-628e34907e98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
liraglutide
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-4060-12Victoza2 in 1 CARTONINJECTION231
0169-4060-12Victoza3 mL in 1 SYRINGE, PLASTICINJECTION331
0169-4060-13Victoza3 in 1 CARTONINJECTION331
0169-4060-13Victoza3 mL in 1 SYRINGE, PLASTICINJECTION331
0169-4060-90Victoza3 mL in 1 SYRINGE, PLASTICINJECTION331
0169-4060-90Victoza1 in 1 CARTONINJECTION131
0169-4060-97Victoza1 in 1 CARTONINJECTION131
0169-4060-97Victoza3 mL in 1 SYRINGE, PLASTICINJECTION331
0169-4060-98Victoza1 in 1 CARTONINJECTION131
0169-4060-98Victoza3 mL in 1 SYRINGE, PLASTICINJECTION331
0169-4060-99Victoza3 mL in 1 SYRINGE, PLASTICINJECTION331
0169-4060-99Victoza1 in 1 CARTONINJECTION131

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-4060-12ML - Milliliter0169-4060711a4e55-c1cd-49f5-93d5-1b5bcf5a72a912012-07-24
0169-4060-13ML - Milliliter0169-4060860580e3-1dc3-47cb-9cf5-2e6fc396150512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIRAGLUTIDEACTIVE INGREDIENT839I73S42AVICTOZA (LIRAGLUTIDE (RDNA ORIGIN) INJECTION) INJECTION, SOLUTION [NOVO NORDISK]15
LIRAGLUTIDEACTIVE MOIETY839I73S42AVICTOZA (LIRAGLUTIDE (RDNA ORIGIN) INJECTION) INJECTION, SOLUTION [NOVO NORDISK]15
PHENOLINACTIVE INGREDIENT339NCG44TVVICTOZA (LIRAGLUTIDE (RDNA ORIGIN) INJECTION) INJECTION, SOLUTION [NOVO NORDISK]15
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VICTOZA (LIRAGLUTIDE (RDNA ORIGIN) INJECTION) INJECTION, SOLUTION [NOVO NORDISK]15
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TVICTOZA (LIRAGLUTIDE (RDNA ORIGIN) INJECTION) INJECTION, SOLUTION [NOVO NORDISK]15
WATERINACTIVE INGREDIENT059QF0KO0RVICTOZA (LIRAGLUTIDE (RDNA ORIGIN) INJECTION) INJECTION, SOLUTION [NOVO NORDISK]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-4060VICTOZA (LIRAGLUTIDE) INJECTION [NOVO NORDISK]29Current NDC, Legacy NDC, 12 package rows20250223_5a9ef4ea-c76a-4d34-a604-27c5b505f5a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897122liraglutide 6 MG/ML in 3 ML Pen InjectorPSN5a9ef4ea-c76a-4d34-a604-27c5b505f5a431
897126Victoza 6 MG/ML in 3 ML Pen InjectorPSN5a9ef4ea-c76a-4d34-a604-27c5b505f5a431
8971263 ML liraglutide 6 MG/ML Pen Injector [Victoza]SBD5a9ef4ea-c76a-4d34-a604-27c5b505f5a431
8971223 ML liraglutide 6 MG/ML Pen InjectorSCD5a9ef4ea-c76a-4d34-a604-27c5b505f5a431
8971263 ML Victoza 6 MG/ML Pen InjectorSY5a9ef4ea-c76a-4d34-a604-27c5b505f5a431
897122liraglutide 18 MG per 3 ML Pen InjectorSY5a9ef4ea-c76a-4d34-a604-27c5b505f5a431
897126Victoza 18 MG per 3 ML Pen InjectorSY5a9ef4ea-c76a-4d34-a604-27c5b505f5a431
897122liraglutide 6 MG/ML in 3 ML Pen InjectorPSN1d18f106-0584-4fee-97ab-32771a64b8099
897126Victoza 6 MG/ML in 3 ML Pen InjectorPSN1d18f106-0584-4fee-97ab-32771a64b8099
8971263 ML liraglutide 6 MG/ML Pen Injector [Victoza]SBD1d18f106-0584-4fee-97ab-32771a64b8099
8971223 ML liraglutide 6 MG/ML Pen InjectorSCD1d18f106-0584-4fee-97ab-32771a64b8099
8971263 ML Victoza 6 MG/ML Pen InjectorSY1d18f106-0584-4fee-97ab-32771a64b8099
897122liraglutide 18 MG per 3 ML Pen InjectorSY1d18f106-0584-4fee-97ab-32771a64b8099
897126Victoza 18 MG per 3 ML Pen InjectorSY1d18f106-0584-4fee-97ab-32771a64b8099
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
0169-4060-12001694060122 SYRINGE, PLASTIC in 1 CARTON (0169-4060-12) / 3 mL in 1 SYRINGE, PLASTIC2010-01-250000-00-00NoNoCurrent
0169-4060-13001694060133 SYRINGE, PLASTIC in 1 CARTON (0169-4060-13) / 3 mL in 1 SYRINGE, PLASTIC2010-01-250000-00-00NoNoCurrent
0169-4060-90001694060901 SYRINGE, PLASTIC in 1 CARTON (0169-4060-90) / 3 mL in 1 SYRINGE, PLASTIC2010-01-250000-00-00YesNoCurrent
0169-4060-97001694060971 in 1 CARTONHistorical
0169-4060-98001694060981 in 1 CARTONHistorical
0169-4060-99001694060991 SYRINGE, PLASTIC in 1 CARTON (0169-4060-99) / 3 mL in 1 SYRINGE, PLASTIC2015-02-130000-00-00YesNoCurrent