OZEMPIC

Product NDC
50090-6051
11-digit product format
500906051
Labeler code
50090
Product ID
50090-6051_52d28c75-c5a5-4389-abff-8a243ba26d99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
semaglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
NDA209637
Marketing category
NDA
Marketing start
2022-04-25
Substance
SEMAGLUTIDE
Active strength
2.68 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
OZEMPIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEMAGLUTIDE2.68 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii53AXN4NNHX
Rxcui2599362, 2599365

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
50090-6051-0OZEMPIC3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION36
50090-6051-0OZEMPIC1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6051-0ML - Milliliter50090-6051076edae7-54c2-41f7-a194-98dc4e78b0a812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6051OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20231118_e6da837c-0da0-41d6-973c-5559bf764367.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2599365OZEMPIC 8 MG in 3 ML Pen InjectorPSNe6da837c-0da0-41d6-973c-5559bf7643676
2599362semaglutide 8 MG in 3 ML Pen InjectorPSNe6da837c-0da0-41d6-973c-5559bf7643676
25993653 ML semaglutide 2.68 MG/ML Pen Injector [Ozempic]SBDe6da837c-0da0-41d6-973c-5559bf7643676
25993623 ML semaglutide 2.68 MG/ML Pen InjectorSCDe6da837c-0da0-41d6-973c-5559bf7643676
2599365Ozempic 2.68 MG/ML per 3 ML Pen InjectorSYe6da837c-0da0-41d6-973c-5559bf7643676
2599365Ozempic 8 MG per 3 ML Pen InjectorSYe6da837c-0da0-41d6-973c-5559bf7643676
2599362semaglutide 2.68 MG/ML per 3 ML Pen InjectorSYe6da837c-0da0-41d6-973c-5559bf7643676
2599362semaglutide 8 MG per 3 ML Pen InjectorSYe6da837c-0da0-41d6-973c-5559bf7643676

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6051-0500906051001 SYRINGE, PLASTIC in 1 CARTON (50090-6051-0) / 3 mL in 1 SYRINGE, PLASTIC2022-08-090000-00-00NoNoCurrent