FDA.reportPublic FDA data

Application 209637

Type
NDA
Sponsor
NOVO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OZEMPICSEMAGLUTIDESOLUTION;SUBCUTANEOUS2MG/1.5ML (1.34MG/ML)YesYes
002OZEMPICSEMAGLUTIDESOLUTION;SUBCUTANEOUS4MG/3ML (1.34MG/ML)YesYes
003OZEMPICSEMAGLUTIDESOLUTION;SUBCUTANEOUS8MG/3ML (2.68MG/ML)YesYes
004OZEMPICSEMAGLUTIDESOLUTION;SUBCUTANEOUS2MG/3ML (0.68MG/ML)YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209637-001OZEMPICSEMAGLUTIDE2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-12-05
N209637-002OZEMPICSEMAGLUTIDE4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-09
N209637-003OZEMPICSEMAGLUTIDE8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-28
N209637-004OZEMPICSEMAGLUTIDE2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-06
N209637-005OZEMPICSEMAGLUTIDE0.25MG/0.5ML (0.25MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-05
N209637-006OZEMPICSEMAGLUTIDE0.5MG/0.5ML (0.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-05
N209637-007OZEMPICSEMAGLUTIDE1MG/0.5ML (1MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-05

Orange Book patents#

Current patent rows page 1 of 2 · 92 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209637-001103576162026-01-20Drug product, Delist requested2019-08-08
N209637-001103766522026-01-20Drug product, Delist requested2019-09-13
N209637-00191080022026-01-20Drug product, Delist requested2017-12-20
N209637-00196161802026-01-20Drug product, Delist requested2018-08-17
N209637-00198617572026-01-20Drug product, Delist requested2018-08-17
N209637-00185361222026-03-20U-2202Drug substance, Drug product2017-12-20
N209637-001102201552026-07-17Drug product, Delist requested2019-04-04
N209637-001110970632026-07-17Drug product, Delist requested2021-09-21
N209637-00189203832026-07-17Drug product, Delist requested2017-12-20
N209637-00197759532026-07-17Drug product, Delist requested2017-12-20
N209637-001RE463632026-08-03Drug product, Delist requested2017-12-20
N209637-00196876112027-02-27Drug product, Delist requested2017-12-20
N209637-00194571542027-09-29Drug product, Delist requested2017-12-20
N209637-00181293432031-12-05U-2202Drug substance, Drug product2017-12-20
N209637-00191322392032-02-01Drug product, Delist requested2017-12-20
N209637-001103354622033-06-21U-25802019-07-25
N209637-002103576162026-01-20Drug product, Delist requested2020-12-21
N209637-002103766522026-01-20Drug product, Delist requested2020-12-21
N209637-00291080022026-01-20Drug product, Delist requested2020-12-21
N209637-00296161802026-01-20Drug product, Delist requested2020-12-21
N209637-00298617572026-01-20Drug product, Delist requested2020-12-21
N209637-00285361222026-03-20U-2202Drug substance, Drug product2020-09-24
N209637-002102201552026-07-17Drug product, Delist requested2020-12-21
N209637-002110970632026-07-17Drug product, Delist requested2021-09-21
N209637-00289203832026-07-17Drug product, Delist requested2020-12-21
N209637-00297759532026-07-17Drug product, Delist requested2020-12-21
N209637-002RE463632026-08-03Drug product, Delist requested2020-12-21
N209637-00296876112027-02-27Drug product, Delist requested2020-12-21
N209637-00294571542027-09-29Drug product, Delist requested2020-12-21
N209637-00281293432031-12-05U-2202Drug substance, Drug product2020-09-24
N209637-00291322392032-02-01Drug product, Delist requested2020-12-21
N209637-002103354622033-06-21U-25802020-09-24
N209637-002125695432037-04-28U-44462026-03-31
N209637-002122959882038-10-10U-18522026-06-23
N209637-003103576162026-01-20Drug product, Delist requested2022-04-29
N209637-003103766522026-01-20Drug product, Delist requested2022-04-29
N209637-00391080022026-01-20Drug product, Delist requested2022-04-29
N209637-00396161802026-01-20Drug product, Delist requested2022-04-29
N209637-00398617572026-01-20Drug product, Delist requested2022-04-29
N209637-00385361222026-03-20U-3355Drug substance, Drug product2022-04-29
N209637-003102201552026-07-17Drug product, Delist requested2022-04-29
N209637-003110970632026-07-17Drug product, Delist requested2022-04-29
N209637-00389203832026-07-17Drug product, Delist requested2022-04-29
N209637-00397759532026-07-17Drug product, Delist requested2022-04-29
N209637-003RE463632026-08-03Drug product, Delist requested2022-04-29
N209637-00396876112027-02-27Drug product, Delist requested2022-04-29
N209637-00394571542027-09-29Drug product, Delist requested2022-04-29
N209637-00381293432031-12-05U-3355Drug substance, Drug product2022-04-29
N209637-00391322392032-02-01Drug product, Delist requested2022-04-29
N209637-003125695432037-04-28U-44462026-03-31
N209637-003122959882038-10-10U-26282025-05-29
N209637-004103576162026-01-20Drug product, Delist requested2022-11-14
N209637-004103766522026-01-20Drug product, Delist requested2022-11-14
N209637-00491080022026-01-20Drug product, Delist requested2022-11-14
N209637-00496161802026-01-20Drug product, Delist requested2022-11-14
N209637-00498617572026-01-20Drug product, Delist requested2022-11-14
N209637-00485361222026-03-20U-3469Drug substance, Drug product2022-11-14
N209637-004102201552026-07-17Drug product, Delist requested2022-11-14
N209637-004110970632026-07-17Drug product, Delist requested2022-11-14
N209637-00489203832026-07-17Drug product, Delist requested2022-11-14
N209637-00497759532026-07-17Drug product, Delist requested2022-11-14
N209637-004RE463632026-08-03Drug product, Delist requested2022-11-14
N209637-00496876112027-02-27Drug product, Delist requested2022-11-14
N209637-00494571542027-09-29Drug product, Delist requested2022-11-14
N209637-00481293432031-12-05U-3469Drug substance, Drug product2022-11-14
N209637-00491322392032-02-01Drug product, Delist requested2022-11-14
N209637-004103354622033-06-21U-2580Drug product2022-11-14
N209637-004125695432037-04-28U-44462026-03-31
N209637-004122959882038-10-10U-18522026-06-23
N209637-00581293432031-12-05U-3355Drug substance, Drug product2026-06-23
N209637-005125695432037-04-28U-44462026-06-23
N209637-005108886052038-08-24U-1852Drug product2026-06-23
N209637-005117521982038-08-24U-1852Drug product2026-06-23
N209637-005122140172038-08-24U-1852Drug product2026-06-23
N209637-005113181912041-02-17U-1852Drug product2026-06-23
N209637-005113181912041-02-17U-4561Drug product2026-06-23
N209637-00681293432031-12-05U-3355Drug substance, Drug product2026-06-23
N209637-006125695432037-04-28U-44462026-06-23
N209637-006108886052038-08-24U-1852Drug product2026-06-23
N209637-006117521982038-08-24U-1852Drug product2026-06-23

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N209637-001I-9612028-01-28
N209637-002I-9612028-01-28
N209637-003I-9612028-01-28
N209637-004I-9612028-01-28

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.

Product history page 1 of 4 · 149 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-12-0584e616aacf4f…
2026-09-14 22:38:342026-08N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-0984e616aacf4f…
2026-09-14 22:38:342026-08N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-2884e616aacf4f…
2026-09-14 22:38:342026-08N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-0684e616aacf4f…
2026-09-14 22:38:342026-08N209637-005OZEMPIC0.25MG/0.5ML (0.25MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-0584e616aacf4f…
2026-09-14 22:38:342026-08N209637-006OZEMPIC0.5MG/0.5ML (0.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-0584e616aacf4f…
2026-09-14 22:38:342026-08N209637-007OZEMPIC1MG/0.5ML (1MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-0584e616aacf4f…
2026-08-18 06:07:402026-07N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-12-05caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-005OZEMPIC0.25MG/0.5ML (0.25MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-006OZEMPIC0.5MG/0.5ML (0.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-007OZEMPIC1MG/0.5ML (1MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-092680178bc6a6…

Observed Orange Book patent history#

Patent history page 1 of 74 · 2,924 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N209637-001103576162026-01-20Drug product, Delist requested2019-08-0884e616aacf4f…
2026-09-14 22:38:342026-08N209637-001103766522026-01-20Drug product, Delist requested2019-09-1384e616aacf4f…
2026-09-14 22:38:342026-08N209637-00191080022026-01-20Drug product, Delist requested2017-12-2084e616aacf4f…
2026-09-14 22:38:342026-08N209637-00196161802026-01-20Drug product, Delist requested2018-08-1784e616aacf4f…
2026-09-14 22:38:342026-08N209637-00198617572026-01-20Drug product, Delist requested2018-08-1784e616aacf4f…
2026-09-14 22:38:342026-08N209637-00185361222026-03-20U-2202Drug substance, Drug product2017-12-2084e616aacf4f…
2026-09-14 22:38:342026-08N209637-001102201552026-07-17Drug product, Delist requested2019-04-0484e616aacf4f…
2026-09-14 22:38:342026-08N209637-001110970632026-07-17Drug product, Delist requested2021-09-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-00189203832026-07-17Drug product, Delist requested2017-12-2084e616aacf4f…
2026-09-14 22:38:342026-08N209637-00197759532026-07-17Drug product, Delist requested2017-12-2084e616aacf4f…
2026-09-14 22:38:342026-08N209637-001RE463632026-08-03Drug product, Delist requested2017-12-2084e616aacf4f…
2026-09-14 22:38:342026-08N209637-00196876112027-02-27Drug product, Delist requested2017-12-2084e616aacf4f…
2026-09-14 22:38:342026-08N209637-00194571542027-09-29Drug product, Delist requested2017-12-2084e616aacf4f…
2026-09-14 22:38:342026-08N209637-00181293432031-12-05U-2202Drug substance, Drug product2017-12-2084e616aacf4f…
2026-09-14 22:38:342026-08N209637-00191322392032-02-01Drug product, Delist requested2017-12-2084e616aacf4f…
2026-09-14 22:38:342026-08N209637-001103354622033-06-21U-25802019-07-2584e616aacf4f…
2026-09-14 22:38:342026-08N209637-002103576162026-01-20Drug product, Delist requested2020-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-002103766522026-01-20Drug product, Delist requested2020-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-00291080022026-01-20Drug product, Delist requested2020-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-00296161802026-01-20Drug product, Delist requested2020-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-00298617572026-01-20Drug product, Delist requested2020-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-00285361222026-03-20U-2202Drug substance, Drug product2020-09-2484e616aacf4f…
2026-09-14 22:38:342026-08N209637-002102201552026-07-17Drug product, Delist requested2020-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-002110970632026-07-17Drug product, Delist requested2021-09-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-00289203832026-07-17Drug product, Delist requested2020-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-00297759532026-07-17Drug product, Delist requested2020-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-002RE463632026-08-03Drug product, Delist requested2020-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-00296876112027-02-27Drug product, Delist requested2020-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-00294571542027-09-29Drug product, Delist requested2020-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-00281293432031-12-05U-2202Drug substance, Drug product2020-09-2484e616aacf4f…
2026-09-14 22:38:342026-08N209637-00291322392032-02-01Drug product, Delist requested2020-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N209637-002103354622033-06-21U-25802020-09-2484e616aacf4f…
2026-09-14 22:38:342026-08N209637-002125695432037-04-28U-44462026-03-3184e616aacf4f…
2026-09-14 22:38:342026-08N209637-002122959882038-10-10U-18522026-06-2384e616aacf4f…
2026-09-14 22:38:342026-08N209637-003103576162026-01-20Drug product, Delist requested2022-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N209637-003103766522026-01-20Drug product, Delist requested2022-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N209637-00391080022026-01-20Drug product, Delist requested2022-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N209637-00396161802026-01-20Drug product, Delist requested2022-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N209637-00398617572026-01-20Drug product, Delist requested2022-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N209637-00385361222026-03-20U-3355Drug substance, Drug product2022-04-2984e616aacf4f…

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209637-002I-8222023-01-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209637-003NCE2022-12-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209637-003D-1852025-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209637-001NCE2022-12-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209637-001I-8222023-01-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209637-002NCE2022-12-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209637-002I-8222023-01-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209637-001NCE2022-12-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N209637-001I-8222023-01-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N209637-002NCE2022-12-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N209637-002I-8222023-01-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209637-001NCE2022-12-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209637-001NCE2022-12-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N209637-001I-8222023-01-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N209637-002NCE2022-12-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N209637-002I-8222023-01-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209637-001NCE2022-12-05782e0a99824c…
2021-12-28 21:50 UTC2021-12N209637-001I-8222023-01-16782e0a99824c…
2021-12-28 21:50 UTC2021-12N209637-002NCE2022-12-05782e0a99824c…
2021-12-28 21:50 UTC2021-12N209637-002I-8222023-01-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209637-001NCE2022-12-0587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209637-001I-8222023-01-1687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209637-002NCE2022-12-0587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209637-002I-8222023-01-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N209637-001NCE2022-12-055aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N209637-001I-8222023-01-165aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N209637-002NCE2022-12-055aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N209637-002I-8222023-01-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209637-001NCE2022-12-058869cabd3fbd…
2020-12-22 03:56 UTC2020-12N209637-001I-8222023-01-168869cabd3fbd…
2020-12-22 03:56 UTC2020-12N209637-002NCE2022-12-058869cabd3fbd…
2020-12-22 03:56 UTC2020-12N209637-002I-8222023-01-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209637-001NCE2022-12-05c0c555d07b60…
2020-11-12 02:37 UTC2020-11N209637-001I-8222023-01-16c0c555d07b60…
2020-11-12 02:37 UTC2020-11N209637-002I-8222023-01-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209637-001NCE2022-12-053f01610625f2…
2019-09-15 20:21 UTC2019-09N209637-001NCE2022-12-05b00525d2431f…
2019-07-19 19:46 UTC2019-07N209637-001NCE2022-12-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209637-003D-1852025-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209637-003D-1852025-03-281c564ffb4f44…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OzempicSEMAGLUTIDEA-S Medication Solutions42bdd912-2393-44c4-b7e0-47672ca289912026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209637
application number: NDA209637
OzempicSEMAGLUTIDEA-S Medication Solutions979e4df4-0597-48ea-b51c-0f699fa6d1662023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209637
application number: NDA209637
ndc (product): 50090-5949
OZEMPICSEMAGLUTIDEA-S Medication Solutionse6da837c-0da0-41d6-973c-5559bf7643672023-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209637
application number: NDA209637
ndc (product): 50090-6051

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-4130OzempicsemaglutideNovo NordiskNDACurrent
0169-4130OzempicsemaglutideNovo NordiskNDACurrent
0169-4130OzempicsemaglutideNovo NordiskNDACurrent
0169-4130OzempicsemaglutideNovo NordiskNDACurrent
0169-4130OzempicsemaglutideNovo NordiskNDACurrent
0169-4130OzempicsemaglutideNovo NordiskNDACurrent
0169-4130OzempicsemaglutideNovo NordiskNDACurrent
0169-4132OzempicsemaglutideNovo NordiskNDACurrent
0169-4132OzempicsemaglutideNovo NordiskNDACurrent
0169-4132OzempicsemaglutideNovo NordiskNDACurrent
0169-4132OzempicsemaglutideNovo NordiskNDACurrent
0169-4132OzempicsemaglutideNovo NordiskNDACurrent
0169-4132OzempicsemaglutideNovo NordiskNDACurrent
0169-4132OzempicsemaglutideNovo NordiskNDACurrent
0169-4132OzempicsemaglutideNovo NordiskNDACurrent
0169-4132OzempicsemaglutideNovo NordiskNDACurrent
0169-4132OzempicsemaglutideNovo NordiskNDACurrent
0169-4132OzempicsemaglutideNovo NordiskNDACurrent
0169-4136OzempicsemaglutideNovo NordiskNDACurrent
0169-4136OzempicsemaglutideNovo NordiskNDACurrent
0169-4136OzempicsemaglutideNovo NordiskNDACurrent
0169-4136OzempicsemaglutideNovo NordiskNDACurrent
0169-4136OzempicsemaglutideNovo NordiskNDACurrent
0169-4136OzempicsemaglutideNovo NordiskNDACurrent
0169-4136OzempicsemaglutideNovo NordiskNDACurrent
0169-4136OzempicsemaglutideNovo NordiskNDACurrent
0169-4136OzempicsemaglutideNovo NordiskNDACurrent
0169-4136OzempicsemaglutideNovo NordiskNDACurrent
0169-4136OzempicsemaglutideNovo NordiskNDACurrent
0169-4181OzempicsemaglutideNovo NordiskNDACurrent
0169-4772OzempicsemaglutideNovo NordiskNDACurrent
0169-4772OzempicsemaglutideNovo NordiskNDACurrent
0169-4772OzempicsemaglutideNovo NordiskNDACurrent
50090-5138OzempicsemaglutideA-S Medication SolutionsNDACurrent
50090-5139OzempicsemaglutideA-S Medication SolutionsNDACurrent
50090-5949OzempicsemaglutideA-S Medication SolutionsNDACurrent
50090-6051OZEMPICsemaglutideA-S Medication SolutionsNDACurrent
50090-6051OZEMPICsemaglutideA-S Medication SolutionsNDACurrent
70518-2143OzempicsemaglutideREMEDYREPACK INC.NDACurrent
70518-2143OzempicsemaglutideREMEDYREPACK INC.NDACurrent
70518-2143OzempicsemaglutideREMEDYREPACK INC.NDACurrent
70518-2143OzempicsemaglutideREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85146SUPPL 2026-02-24
85119SUPPL 2026-02-24
85118SUPPL 2026-02-24
83783SUPPL 2025-10-15
83782SUPPL 2025-10-15
83781SUPPL 2025-10-15
83776SUPPL 2025-10-15
83775SUPPL 2025-10-15
81169SUPPL 2025-02-07
80998SUPPL 2025-02-05
80142SUPPL 2024-11-05
80127SUPPL 2024-11-05
75556SUPPL 2023-09-25
75555SUPPL 2023-09-25
75551SUPPL 2023-09-25
75550SUPPL 2023-09-25
72296SUPPL2022-10-11
72295SUPPL2022-10-11
72275SUPPL2022-10-07
70645SUPPL2022-03-29
70644SUPPL2022-03-29
70639SUPPL2022-03-29
67061SUPPL2021-04-14
67060SUPPL2021-04-14
67048SUPPL2021-04-13
61599SUPPL2020-01-17
61594SUPPL2020-01-17
61593SUPPL2020-01-17
61112SUPPL2019-12-02
61113SUPPL2019-11-29
61094SUPPL2019-11-29
58289SUPPL2019-04-11
58271SUPPL2019-04-10
51050ORIG2018-01-16
50623ORIG2017-12-07
50622ORIG2017-12-06