FDA.reportPublic FDA data

Ozempic

Product NDC
50090-5139
Requested package NDC
50090-5139-0
11-digit product format
500905139
Labeler code
50090
Product ID
50090-5139_c4869820-1a83-42b5-8ba0-46fa98e373fd
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
2017-12-06
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-513950090-5139-0IInactivated by FDA2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5139-02023-01-30C16284748780-1f386c64a-356b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OZEMPIC ® safely and effectively. See full prescribing information for OZEMPIC. OZEMPIC (semaglutide) injection, for subcutaneous use Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5139-0Ozempic2 in 1 CARTONINJECTION, SOLUTION21
50090-5139-0Ozempic1.5 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5139OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20210115_35902e95-e00c-47ae-8f4e-ba17d41881ce.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1991317OZEMPIC 2 MG in 1.5 ML Pen Injector, 1 MG DosePSN35902e95-e00c-47ae-8f4e-ba17d41881ce1
1991316semaglutide 2 MG in 1.5 ML Pen Injector, 1 MG DosePSN35902e95-e00c-47ae-8f4e-ba17d41881ce1
19913171 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]SBD35902e95-e00c-47ae-8f4e-ba17d41881ce1
19913161 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen InjectorSCD35902e95-e00c-47ae-8f4e-ba17d41881ce1
19913171 MG Dose 1.5 ML Ozempic 1.34 MG/ML Pen InjectorSY35902e95-e00c-47ae-8f4e-ba17d41881ce1
1991317OZEMPIC 2 MG per 1.5 ML Pen Injector, 1 MG DoseSY35902e95-e00c-47ae-8f4e-ba17d41881ce1
1991316semaglutide 2 MG per 1.5 ML Pen Injector, 1 MG DoseSY35902e95-e00c-47ae-8f4e-ba17d41881ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5139-0500905139002 SYRINGE, PLASTIC in 1 CARTON (50090-5139-0) > 1.5 mL in 1 SYRINGE, PLASTIC2020-08-310000-00-00NoNoCurrent