FDA.reportPublic FDA data

Ozempic

Product NDC
0169-4136
11-digit product format
001694136
Labeler code
0169
Product ID
0169-4136_89435b5f-007a-4880-954e-a870b8922b42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
semaglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk
Application
NDA209637
Marketing category
NDA
Marketing start
2017-12-06
Marketing end
0000-00-00
Substance
SEMAGLUTIDE
Active strength
1 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
2023-12-31
Current FDA listing
Historical FDA.report record

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
0169-4136-02Ozempic2 in 1 CARTONINJECTION, SOLUTION219
0169-4136-11Ozempic1.5 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION1.519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-4136-02ML - Milliliter0169-41363fdaa81b-641e-43a4-aa52-f79ab12d19d712018-01-12
0169-4136-11ML - Milliliter0169-4136c6d21a74-218e-45a7-9d89-8a91835fb93312019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-4136OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK]16Legacy NDC, 2 package rows20250210_adec4fd2-6858-4c99-91d4-531f5f2a2d79.zip

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
1991317OZEMPIC 2 MG in 1.5 ML Pen Injector, 1 MG DosePSN35902e95-e00c-47ae-8f4e-ba17d41881ce1
1991316semaglutide 2 MG in 1.5 ML Pen Injector, 1 MG DosePSN35902e95-e00c-47ae-8f4e-ba17d41881ce1
19913171 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]SBD35902e95-e00c-47ae-8f4e-ba17d41881ce1
19913161 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen InjectorSCD35902e95-e00c-47ae-8f4e-ba17d41881ce1
19913171 MG Dose 1.5 ML Ozempic 1.34 MG/ML Pen InjectorSY35902e95-e00c-47ae-8f4e-ba17d41881ce1
1991317OZEMPIC 2 MG per 1.5 ML Pen Injector, 1 MG DoseSY35902e95-e00c-47ae-8f4e-ba17d41881ce1
1991316semaglutide 2 MG per 1.5 ML Pen Injector, 1 MG DoseSY35902e95-e00c-47ae-8f4e-ba17d41881ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0169-4136-02001694136022 SYRINGE, PLASTIC in 1 CARTON (0169-4136-02) > 1.5 mL in 1 SYRINGE, PLASTIC (0169-4136-11) 2017-12-062023-10-31NoNoCurrent
0169-4136-11001694136111.5 mL in 1 SYRINGE, PLASTIC1.5 mlHistorical