WEGOVY

Product NDC
0169-4404
11-digit product format
001694404
Labeler code
0169
Product ID
0169-4404_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
4 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218316-001WEGOVYSEMAGLUTIDE1.5MGTABLET / ORALRLD, RS2025-12-22
N218316-002WEGOVYSEMAGLUTIDE4MGTABLET / ORALRLD, RS2025-12-22
N218316-003WEGOVYSEMAGLUTIDE9MGTABLET / ORALRLD, RS2025-12-22
N218316-004WEGOVYSEMAGLUTIDE25MGTABLET / ORALRLD, RS2025-12-22

Orange Book patents#

Current patent rows page 1 of 1 · 34 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218316-00185361222026-03-20Drug substance, Drug product2026-02-04
N218316-00181293432031-12-05Drug substance, Drug product2026-02-04
N218316-001113829572031-12-16Drug product2026-01-16
N218316-001110334992033-06-19U-4496Drug product2026-05-07
N218316-001102789232034-05-02U-43892026-01-16
N218316-001122397392034-05-02U-43882026-01-16
N218316-001118332482039-02-01U-4387Drug product2026-01-16
N218316-001123969532039-02-01U-4387Drug product2026-01-16
N218316-00285361222026-03-20Drug substance, Drug product2026-02-04
N218316-00281293432031-12-05Drug substance, Drug product2026-02-04
N218316-002113829572031-12-16Drug product2026-01-16
N218316-002110334992033-06-19U-4496Drug product2026-05-07
N218316-002102789232034-05-02U-43892026-01-16
N218316-002122397392034-05-02U-43882026-01-16
N218316-002118332482039-02-01U-4387Drug product2026-01-16
N218316-002123969532039-02-01U-4387Drug product2026-01-16
N218316-00385361222026-03-20Drug substance, Drug product2026-02-04
N218316-00381293432031-12-05Drug substance, Drug product2026-02-04
N218316-003113829572031-12-16Drug product2026-01-16
N218316-00392781232031-12-16U-4389Drug product2026-02-05
N218316-003110334992033-06-19U-4496Drug product2026-05-07
N218316-003102789232034-05-02U-43892026-01-16
N218316-003122397392034-05-02U-43882026-01-16
N218316-003118332482039-02-01U-4387Drug product2026-01-16
N218316-003123969532039-02-01U-4387Drug product2026-01-16
N218316-00485361222026-03-20Drug substance, Drug product2026-02-04
N218316-00481293432031-12-05Drug substance, Drug product2026-02-04
N218316-004113829572031-12-16Drug product2026-01-16
N218316-00492781232031-12-16U-4389Drug product2026-01-16
N218316-004110334992033-06-19U-4496Drug product2026-05-07
N218316-004102789232034-05-02U-43892026-01-16
N218316-004122397392034-05-02U-43882026-01-16
N218316-004118332482039-02-01U-4387Drug product2026-01-16
N218316-004123969532039-02-01U-4387Drug product2026-01-16

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218316-001I-9352027-03-08
N218316-001NP2028-12-22
N218316-002I-9352027-03-08
N218316-002NP2028-12-22
N218316-003I-9352027-03-08
N218316-003NP2028-12-22
N218316-004I-9352027-03-08
N218316-004NP2028-12-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N218316-001WEGOVY1.5MGTABLET / ORALRLD, RS2025-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-002WEGOVY4MGTABLET / ORALRLD, RS2025-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-003WEGOVY9MGTABLET / ORALRLD, RS2025-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-004WEGOVY25MGTABLET / ORALRLD, RS2025-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218316-001WEGOVY1.5MGTABLET / ORALRLD2025-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218316-002WEGOVY4MGTABLET / ORALRLD2025-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218316-003WEGOVY9MGTABLET / ORALRLD2025-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218316-004WEGOVY25MGTABLET / ORALRLD, RS2025-12-22011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218316-001WEGOVY1.5MGTABLET / ORALRLD, RS2025-12-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218316-002WEGOVY4MGTABLET / ORALRLD, RS2025-12-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218316-003WEGOVY9MGTABLET / ORALRLD, RS2025-12-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218316-004WEGOVY25MGTABLET / ORALRLD, RS2025-12-22a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 98 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N218316-00185361222026-03-20Drug substance, Drug product2026-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-00181293432031-12-05Drug substance, Drug product2026-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-001113829572031-12-16Drug product2026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-001110334992033-06-19U-4496Drug product2026-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-001102789232034-05-02U-43892026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-001122397392034-05-02U-43882026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-001118332482039-02-01U-4387Drug product2026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-001123969532039-02-01U-4387Drug product2026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-00285361222026-03-20Drug substance, Drug product2026-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-00281293432031-12-05Drug substance, Drug product2026-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-002113829572031-12-16Drug product2026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-002110334992033-06-19U-4496Drug product2026-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-002102789232034-05-02U-43892026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-002122397392034-05-02U-43882026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-002118332482039-02-01U-4387Drug product2026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-002123969532039-02-01U-4387Drug product2026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-00385361222026-03-20Drug substance, Drug product2026-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-00381293432031-12-05Drug substance, Drug product2026-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-003113829572031-12-16Drug product2026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-00392781232031-12-16U-4389Drug product2026-02-05caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-003110334992033-06-19U-4496Drug product2026-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-003102789232034-05-02U-43892026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-003122397392034-05-02U-43882026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-003118332482039-02-01U-4387Drug product2026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-003123969532039-02-01U-4387Drug product2026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-00485361222026-03-20Drug substance, Drug product2026-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-00481293432031-12-05Drug substance, Drug product2026-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-004113829572031-12-16Drug product2026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-00492781232031-12-16U-4389Drug product2026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-004110334992033-06-19U-4496Drug product2026-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-004102789232034-05-02U-43892026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-004122397392034-05-02U-43882026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-004118332482039-02-01U-4387Drug product2026-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-004123969532039-02-01U-4387Drug product2026-01-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218316-00185361222026-03-20Drug substance, Drug product2026-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218316-00181293432031-12-05Drug substance, Drug product2026-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218316-001113829572031-12-16Drug product2026-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218316-001102789232034-05-02U-43892026-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218316-001122397392034-05-02U-43882026-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218316-001118332482039-02-01U-4387Drug product2026-01-16011fe1cb6892…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N218316-001I-9352027-03-08caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-001NP2028-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-002I-9352027-03-08caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-002NP2028-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-003I-9352027-03-08caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-003NP2028-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-004I-9352027-03-08caaa826d4ba7…
2026-08-18 06:07:402026-07N218316-004NP2028-12-22caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218316-001I-9352027-03-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218316-001NP2028-12-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218316-002I-9352027-03-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218316-002NP2028-12-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218316-003I-9352027-03-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218316-003NP2028-12-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218316-004I-9352027-03-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218316-004NP2028-12-22a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
WEGOVY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEMAGLUTIDE4 mg/1

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
0169-4404-31WEGOVY30 in 1 BOTTLE, PLASTICTABLET3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-4404-31EA - Each0169-4404b59a5a43-a867-4680-9cf1-22f53b77059c12026-01-08

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
0169-4404-310016944043130 TABLET in 1 BOTTLE, PLASTIC (0169-4404-31) 30 tablet2026-01-06NoNoCurrent