FDA.reportPublic FDA data

Ozempic

Product NDC
70518-2143
11-digit product format
705182143
Labeler code
70518
Product ID
70518-2143_c68a9472-9ccd-d006-e053-2a95a90a647b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
semaglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
REMEDYREPACK INC.
Application
NDA209637
Marketing category
NDA
Marketing start
2019-06-11
Marketing end
0000-00-00
Substance
SEMAGLUTIDE
Active strength
1 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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2143DDiscontinued by firm2026-08-17
excluded packagepackage70518-214370518-2143-0DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2143-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2143-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2143-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2143-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2143-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2143-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2143-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2143-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2143-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2143-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2143-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2143-0557ba5c1ecfa…9c80585c8c6e…

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

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 · 142 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-05d8e5a09893c0…

Observed Orange Book patent history#

Patent history page 1 of 71 · 2,832 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N209637-001103576162026-01-20Drug product, Delist requested2019-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-001103766522026-01-20Drug product, Delist requested2019-09-13caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00191080022026-01-20Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00196161802026-01-20Drug product, Delist requested2018-08-17caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00198617572026-01-20Drug product, Delist requested2018-08-17caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00185361222026-03-20U-2202Drug substance, Drug product2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-001102201552026-07-17Drug product, Delist requested2019-04-04caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-001110970632026-07-17Drug product, Delist requested2021-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00189203832026-07-17Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00197759532026-07-17Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-001RE463632026-08-03Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00196876112027-02-27Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00194571542027-09-29Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00181293432031-12-05U-2202Drug substance, Drug product2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00191322392032-02-01Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-001103354622033-06-21U-25802019-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002103576162026-01-20Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002103766522026-01-20Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00291080022026-01-20Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00296161802026-01-20Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00298617572026-01-20Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00285361222026-03-20U-2202Drug substance, Drug product2020-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002102201552026-07-17Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002110970632026-07-17Drug product, Delist requested2021-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00289203832026-07-17Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00297759532026-07-17Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002RE463632026-08-03Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00296876112027-02-27Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00294571542027-09-29Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00281293432031-12-05U-2202Drug substance, Drug product2020-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00291322392032-02-01Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002103354622033-06-21U-25802020-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002125695432037-04-28U-44462026-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002122959882038-10-10U-18522026-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-003103576162026-01-20Drug product, Delist requested2022-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-003103766522026-01-20Drug product, Delist requested2022-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00391080022026-01-20Drug product, Delist requested2022-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00396161802026-01-20Drug product, Delist requested2022-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00398617572026-01-20Drug product, Delist requested2022-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00385361222026-03-20U-3355Drug substance, Drug product2022-04-29caaa826d4ba7…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N209637-001I-9612028-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002I-9612028-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-003I-9612028-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-004I-9612028-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209637-001I-9612028-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-002I-9612028-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-003I-9612028-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-004I-9612028-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-001I-9612028-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-002I-9612028-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-003D-1852025-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-003I-9612028-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-004I-9612028-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N209637-001I-9612028-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-002I-9612028-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-003D-1852025-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-003I-9612028-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-004I-9612028-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-001I-9612028-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-002I-9612028-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-003D-1852025-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-003I-9612028-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-004I-9612028-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209637-003D-1852025-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209637-003D-1852025-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209637-003D-1852025-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209637-003D-1852025-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209637-003D-1852025-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209637-003D-1852025-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209637-003D-1852025-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209637-003D-1852025-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209637-003D-1852025-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209637-003D-1852025-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209637-001NCE2022-12-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209637-001I-8222023-01-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209637-002NCE2022-12-055c6f7cd8ea54…
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…

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
OZEMPICSEMAGLUTIDEA-S Medication Solutionse6da837c-0da0-41d6-973c-5559bf7643672023-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209637
application number: NDA209637

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2143-0705182143002 SYRINGE, PLASTIC in 1 CARTON (70518-2143-0) > 1.5 mL in 1 SYRINGE, PLASTIC2019-06-110000-00-00NoNoCurrent