Ozempic

Product NDC
50090-5949
11-digit product format
500905949
Labeler code
50090
Product ID
50090-5949_a5c23c93-1c61-4768-b7f2-1e430cd21a8d
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
2020-09-30
Substance
SEMAGLUTIDE
Active strength
1.34 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
SEMAGLUTIDE1.34 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii53AXN4NNHX
Rxcui2398841, 2398842

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
50090-5949-0Ozempic3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION33
50090-5949-0Ozempic1 in 1 CARTONINJECTION, SOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5949-0ML - Milliliter50090-5949aa7d5807-5d9c-4d47-837a-2bf4e0f691bd12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5949OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20231123_979e4df4-0597-48ea-b51c-0f699fa6d166.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2398842OZEMPIC 4 MG in 3 ML Pen InjectorPSN979e4df4-0597-48ea-b51c-0f699fa6d1663
2398841semaglutide 4 MG in 3 ML Pen InjectorPSN979e4df4-0597-48ea-b51c-0f699fa6d1663
23988423 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]SBD979e4df4-0597-48ea-b51c-0f699fa6d1663
23988413 ML semaglutide 1.34 MG/ML Pen InjectorSCD979e4df4-0597-48ea-b51c-0f699fa6d1663
23988423 ML Ozempic 1.34 MG/ML Pen InjectorSY979e4df4-0597-48ea-b51c-0f699fa6d1663
2398841semaglutide 4 MG in 3 ML Pen InjectorSY979e4df4-0597-48ea-b51c-0f699fa6d1663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5949-0500905949001 SYRINGE, PLASTIC in 1 CARTON (50090-5949-0) / 3 mL in 1 SYRINGE, PLASTIC2022-04-010000-00-00NoNoCurrent