FDA.reportPublic FDA data

WEGOVY

Product NDC
0169-4415
11-digit product format
001694415
Labeler code
0169
Product ID
0169-4415_2cf550fd-3019-4202-b112-2009de398600
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
semaglutide
Dosage form
TABLET
Route
ORAL
Labeler
Novo Nordisk Pharmaceutical Industries, LP
Application
NDA218316
Marketing category
NDA
Marketing start
2026-01-06
Substance
SEMAGLUTIDE
Active strength
1.5 mg/1
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
WEGOVY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEMAGLUTIDE1.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii53AXN4NNHX
Rxcui2553501, 2553506, 2553601, 2553603, 2553802, 2553803, 2553901, 2553903, 2554102, 2554104, 2707547, 2707551, 2707555, 2730161, 2730163, 2730165, 2730167, 2730169, 2739768, 2739771

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
0169-4415-31WEGOVY30 in 1 BOTTLE, PLASTICTABLET3018
0169-4415-92WEGOVY30 in 1 BOTTLE, PLASTICTABLET3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-4415-31EA - Each0169-4415a468273d-233c-4977-91a4-d22b70ff5d6612026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2553501semaglutide 0.25 MG in 0.5 ML Auto-InjectorPSNee06186f-2aa3-4990-a760-757579d8f77b18
2553601semaglutide 0.5 MG in 0.5 ML Auto-InjectorPSNee06186f-2aa3-4990-a760-757579d8f77b18
2553802semaglutide 1 MG in 0.5 ML Auto-InjectorPSNee06186f-2aa3-4990-a760-757579d8f77b18
2707547semaglutide 1.5 MG Oral TabletPSNee06186f-2aa3-4990-a760-757579d8f77b18
2553901semaglutide 1.7 MG in 0.75 ML Auto-InjectorPSNee06186f-2aa3-4990-a760-757579d8f77b18
2554102semaglutide 2.4 MG in 0.75 ML Auto-InjectorPSNee06186f-2aa3-4990-a760-757579d8f77b18
2730163semaglutide 25 MG Oral TabletPSNee06186f-2aa3-4990-a760-757579d8f77b18
2707551semaglutide 4 MG Oral TabletPSNee06186f-2aa3-4990-a760-757579d8f77b18
2739768semaglutide 7.2 MG in 0.75 ML Auto-InjectorPSNee06186f-2aa3-4990-a760-757579d8f77b18
2707555semaglutide 9 MG Oral TabletPSNee06186f-2aa3-4990-a760-757579d8f77b18
2553506wegovy 0.25 MG in 0.5 ML Auto-InjectorPSNee06186f-2aa3-4990-a760-757579d8f77b18
2553603wegovy 0.5 MG in 0.5 ML Auto-InjectorPSNee06186f-2aa3-4990-a760-757579d8f77b18
2553803wegovy 1 MG in 0.5 ML Auto-InjectorPSNee06186f-2aa3-4990-a760-757579d8f77b18
2730161wegovy 1.5 MG Oral TabletPSNee06186f-2aa3-4990-a760-757579d8f77b18
2553903wegovy 1.7 MG in 0.75 ML Auto-InjectorPSNee06186f-2aa3-4990-a760-757579d8f77b18
2554104wegovy 2.4 MG in 0.75 ML Auto-InjectorPSNee06186f-2aa3-4990-a760-757579d8f77b18
2730165wegovy 25 MG Oral TabletPSNee06186f-2aa3-4990-a760-757579d8f77b18
2730167wegovy 4 MG Oral TabletPSNee06186f-2aa3-4990-a760-757579d8f77b18
2730169wegovy 9 MG Oral TabletPSNee06186f-2aa3-4990-a760-757579d8f77b18
2739771wegovy HD 7.2 MG in 0.75 ML Auto-InjectorPSNee06186f-2aa3-4990-a760-757579d8f77b18
25535060.5 ML semaglutide 0.5 MG/ML Auto-Injector [Wegovy]SBDee06186f-2aa3-4990-a760-757579d8f77b18
25536030.5 ML semaglutide 1 MG/ML Auto-Injector [Wegovy]SBDee06186f-2aa3-4990-a760-757579d8f77b18
25538030.5 ML semaglutide 2 MG/ML Auto-Injector [Wegovy]SBDee06186f-2aa3-4990-a760-757579d8f77b18
25539030.75 ML semaglutide 2.27 MG/ML Auto-Injector [Wegovy]SBDee06186f-2aa3-4990-a760-757579d8f77b18
25541040.75 ML semaglutide 3.2 MG/ML Auto-Injector [Wegovy]SBDee06186f-2aa3-4990-a760-757579d8f77b18
27397710.75 ML semaglutide 9.6 MG/ML Auto-Injector [Wegovy]SBDee06186f-2aa3-4990-a760-757579d8f77b18
2730161semaglutide 1.5 MG Oral Tablet [Wegovy]SBDee06186f-2aa3-4990-a760-757579d8f77b18
2730165semaglutide 25 MG Oral Tablet [Wegovy]SBDee06186f-2aa3-4990-a760-757579d8f77b18
2730167semaglutide 4 MG Oral Tablet [Wegovy]SBDee06186f-2aa3-4990-a760-757579d8f77b18
2730169semaglutide 9 MG Oral Tablet [Wegovy]SBDee06186f-2aa3-4990-a760-757579d8f77b18
25535010.5 ML semaglutide 0.5 MG/ML Auto-InjectorSCDee06186f-2aa3-4990-a760-757579d8f77b18
25536010.5 ML semaglutide 1 MG/ML Auto-InjectorSCDee06186f-2aa3-4990-a760-757579d8f77b18
25538020.5 ML semaglutide 2 MG/ML Auto-InjectorSCDee06186f-2aa3-4990-a760-757579d8f77b18
25539010.75 ML semaglutide 2.27 MG/ML Auto-InjectorSCDee06186f-2aa3-4990-a760-757579d8f77b18
25541020.75 ML semaglutide 3.2 MG/ML Auto-InjectorSCDee06186f-2aa3-4990-a760-757579d8f77b18
27397680.75 ML semaglutide 9.6 MG/ML Auto-InjectorSCDee06186f-2aa3-4990-a760-757579d8f77b18
2707547semaglutide 1.5 MG Oral TabletSCDee06186f-2aa3-4990-a760-757579d8f77b18
2730163semaglutide 25 MG Oral TabletSCDee06186f-2aa3-4990-a760-757579d8f77b18
2707551semaglutide 4 MG Oral TabletSCDee06186f-2aa3-4990-a760-757579d8f77b18
2707555semaglutide 9 MG Oral TabletSCDee06186f-2aa3-4990-a760-757579d8f77b18
2553501semaglutide 0.25 MG per 0.5 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18
2553601semaglutide 0.5 MG per 0.5 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18
2553802semaglutide 1 MG per 0.5 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18
2553901semaglutide 1.7 MG per 0.75 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18
2554102semaglutide 2.4 MG per 0.75 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18
2739768semaglutide 7.2 MG per 0.75 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18
2739768semaglutide 9.6 MG/ML per 0.75 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18
2553506Wegovy 0.25 MG per 0.5 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18
2553603Wegovy 0.5 MG per 0.5 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18
2553803Wegovy 1 MG per 0.5 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18
2730161Wegovy 1.5 MG Oral TabletSYee06186f-2aa3-4990-a760-757579d8f77b18
2553903Wegovy 1.7 MG per 0.75 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18
2554104Wegovy 2.4 MG per 0.75 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18
2730165Wegovy 25 MG Oral TabletSYee06186f-2aa3-4990-a760-757579d8f77b18
2730167Wegovy 4 MG Oral TabletSYee06186f-2aa3-4990-a760-757579d8f77b18
2739771Wegovy 7.2 MG per 0.75 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18
2730169Wegovy 9 MG Oral TabletSYee06186f-2aa3-4990-a760-757579d8f77b18
2739771Wegovy 9.6 MG/ML per 0.75 ML Auto-InjectorSYee06186f-2aa3-4990-a760-757579d8f77b18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0169-4415-310016944153130 TABLET in 1 BOTTLE, PLASTIC (0169-4415-31) 30 tablet2026-01-06NoNoHistorical
0169-4415-920016944159230 TABLET in 1 BOTTLE, PLASTIC (0169-4415-92) 30 tablet2026-01-06YesNoHistorical