FDA.reportPublic FDA data

Ozempic

Product NDC
0169-1302
11-digit product format
001691302
Labeler code
0169
Product ID
0169-1302_852fff2d-704e-4b01-9244-439a28094202
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
semaglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk Pharmaceutical Industries, LP
Application
NDA209637
Marketing category
NDA
Marketing start
2022-10-07
Substance
SEMAGLUTIDE
Active strength
.25 mg/.5mL
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
Ozempic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEMAGLUTIDE.25 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii53AXN4NNHX

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9dd2abc7-744f-456b-a273-dec083824bd8Product name220240229
487bac84-7c5b-40cf-afd2-8b9674d4648eProduct name120220118
21318a8d-e167-4f44-9627-3daede9532ffProduct name120200227

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-1302-01Ozempic0.5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.519
0169-1302-14Ozempic4 in 1 CARTONINJECTION, SOLUTION419
0169-1302-90Ozempic0.5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.519
0169-1302-94Ozempic4 in 1 CARTONINJECTION, SOLUTION419

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1991311OZEMPIC 2 MG in 1.5 ML Pen Injector, 0.25 or 0.5 MG DosePSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991317OZEMPIC 2 MG in 1.5 ML Pen Injector, 1 MG DosePSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2619154OZEMPIC 2 MG in 3 ML Pen Injector, 0.25 or 0.5 MG DosePSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2398842OZEMPIC 4 MG in 3 ML Pen InjectorPSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2599365OZEMPIC 8 MG in 3 ML Pen InjectorPSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991306semaglutide 2 MG in 1.5 ML Pen Injector, 0.25 or 0.5 MG DosePSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991316semaglutide 2 MG in 1.5 ML Pen Injector, 1 MG DosePSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2619152semaglutide 2 MG in 3 ML Pen Injector, 0.25 MG, 0.5 MG DosePSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2398841semaglutide 4 MG in 3 ML Pen InjectorPSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2599362semaglutide 8 MG in 3 ML Pen InjectorPSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
19913110.25 MG, 0.5 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]SBDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
26191540.25 MG, 0.5 MG Dose 3 ML semaglutide 0.68 MG/ML Pen Injector [Ozempic]SBDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
19913171 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]SBDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
23988423 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]SBDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
25993653 ML semaglutide 2.68 MG/ML Pen Injector [Ozempic]SBDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
19913060.25 MG, 0.5 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen InjectorSCDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
26191520.25 MG, 0.5 MG Dose 3 ML semaglutide 0.68 MG/ML Pen InjectorSCDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
19913161 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen InjectorSCDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
23988413 ML semaglutide 1.34 MG/ML Pen InjectorSCDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
25993623 ML semaglutide 2.68 MG/ML Pen InjectorSCDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
19913110.25 MG, 0.5 MG Dose 1.5 ML Ozempic 1.34 MG/ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
26191540.25 MG, 0.5 MG Dose 3 ML Ozempic 0.68 MG/ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
26191520.25 MG, 0.5 MG Dose semaglutide 2 MG per 3 ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
19913171 MG Dose 1.5 ML Ozempic 1.34 MG/ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
23988423 ML Ozempic 1.34 MG/ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991311OZEMPIC 2 MG per 1.5 ML Pen Injector, 0.25 or 0.5 MG DoseSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991317OZEMPIC 2 MG per 1.5 ML Pen Injector, 1 MG DoseSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2599365Ozempic 2.68 MG/ML per 3 ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2599365Ozempic 8 MG per 3 ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991306semaglutide 2 MG per 1.5 ML Pen Injector, 0.25 or 0.5 MG DoseSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991316semaglutide 2 MG per 1.5 ML Pen Injector, 1 MG DoseSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2599362semaglutide 2.68 MG/ML per 3 ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2398841semaglutide 4 MG in 3 ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2599362semaglutide 8 MG per 3 ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0169-1302-01001691302010.5 mL in 1 SYRINGE, GLASS0.5 mlHistorical
0169-1302-14001691302144 in 1 CARTONHistorical
0169-1302-90001691302900.5 mL in 1 SYRINGE, GLASS0.5 mlHistorical
0169-1302-94001691302944 in 1 CARTONHistorical